Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
154
Countries
8
Sites
28
Chemotherapy-induced Thrombocytopenia in Adult Subjects with Gastrointestinal, Pancreatic, or Colorectal Cancer
To evaluate the efficacy of romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of gastrointestinal, pancreatic, or colorectal cancer, measured by the ability to administer on-time, full-dose chemotherapy
Key facts
- Sponsor
- Amgen Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 3 Oct 2019 → 10 Jan 2025
- Decision date (initial)
- 2023-12-21
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Amgen Inc.
External identifiers
- EU CT number
- 2023-507148-35-00
- EudraCT number
- 2017-002992-25
- WHO UTN
- U1111-1295-1928
- ClinicalTrials.gov
- NCT03362177
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To evaluate the efficacy of romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of gastrointestinal, pancreatic, or colorectal cancer, measured by the ability to administer on-time, full-dose chemotherapy
Secondary objectives 7
- To compare the treatment effect of romiplostim with that of placebo on the depth of platelet nadir
- To compare the treatment effect of romiplostim with that of placebo on the time to first platelet response
- To compare the treatment effect of romiplostim with that of placebo on the incidence of ≥ grade 2 bleeding events
- To compare the treatment effect of romiplostim with that of placebo on overall survival
- To compare the treatment effect of romiplostim with that of placebo on the incidence of platelet transfusions
- To compare the treatment effect of romiplostim with that of placebo on the proportion of patients achieving platelet response
- Overall safety of Romiplostim
Conditions and MedDRA coding
Chemotherapy-induced Thrombocytopenia in Adult Subjects with Gastrointestinal, Pancreatic, or Colorectal Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10053548 | Gastrointestinal cancer metastatic | 100000004864 |
| 21.0 | PT | 10052360 | Colorectal adenocarcinoma | 100000004864 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Study of Romiplostim for CIT in in Adult Subjects with Gastrointestinal or Colorectal Cancer. This study is to learn more about the study drug romiplostim in people with chemotherapy-induced thrombocytopenia (CIT) receiving chemotherapy for the treatment of gastrointestinal, pancreatic or colorectal cancer.
|
Randomised Controlled | Double | [{"id":131779,"code":1,"name":"Subject"},{"id":131778,"code":4,"name":"Analyst"},{"id":131777,"code":3,"name":"Monitor"},{"id":131775,"code":2,"name":"Investigator"},{"id":131776,"code":5,"name":"Carer"}] | Romiplostim/Treatment Arm: This is a phase 3, randomized, placebo-controlled, multicenter, international study for the treatment of CIT in adult subjects receiving oxaliplatin-based chemotherapy for the treatment of gastrointestinal, pancreatic, or colorectal cancer. Subjects must have a platelet count ≤ 85 x 109/L on day 1 of the study. The study will consist of a screening period of up to 4 weeks, a treatment period long enough to allow for assessment of 3 planned cycles of chemotherapy, a follow-up visit, and long-term follow-up (LTFU). Given that subjects will be assessed for 3 planned cycles of chemotherapy, the oxaliplatin-based chemotherapy cycles are 2-3 weeks in duration, and the investigational product dose adjustment guidelines allow for up to 12 weeks of dosing before a subject is declared a non-responder, the majority of study subjects will receive investigational product for a range of between 7-21 weeks. Once eligibility is confirmed, subjects will be randomized on day 1 of the study in a 2 to 1 ratio to receive either romiplostim or placebo, espectively. Randomization will be stratified by tumor type and baseline platelet count (< 50 x 109/L, ≥ 50 x 109/L). Baseline platelet count is defined as platelet count measured most prior to the time of the planned investigational product administration. Gastrointestinal denocarcinomas, including tumors of the esophagus and stomach, will be included in one stratum, pancreatic cancers in a second stratum, and colorectal cancers, including adenocarcinomas of the colon or rectum, will be included in a third stratum. Subjects will then enter the treatment period, during which time they will return to the clinic weekly for local platelet counts, undergo dose titrations as needed, and investigational product administration. If there are multiple platelet values performed on a study visit date, the platelet value from the test performed most immediately prior to the time of the planned investigational product and/or non-investigational product administration will be recorded as the platelet value for that study visit date and will be used to determine the subject’s dose of investigational product and, when applicable, chemotherapy dose modifications, which include dose reductions, delays, omissions, and discontinuations. Subjects will receive weekly subcutaneous injections of investigational product throughout the treatment period, starting at 2 microgram/kg and increasing by increments of 1 microgramg/kg to a maximum dose of 10 microgramg/kg to reach a target platelet count of≥100 x 10-*9/L. If the subject will be receiving concomitant chemotherapy on a study visit date, investigational product will be administered immediately after the completion of chemotherapy infusion on chemotherapy day 1. If continuous infusion 5-FU over 46-48 hours is part of the chemotherapy regimen the investigational product may be administered prior to beginning or during the continuous infusion 5-FU.Subjects will have a follow-up Visit 1 week after the last dose of investigational product. Subjects will have their first in-clinic LTFU Visit 30 (+5) days after the last dose of investigational product (Safety Follow-up 1). Subjects will be contacted 30 (+5) days after the last dose of the last on-study cycle of chemotherapy (up to 3 cycles) to collect adverse event information except for females who are in addition required to come to clinic for a highly sensitive urine or serum pregnancy test (Safety Follow-up 2). Subjects will remain in LTFU until the last subject in the trial completes the LTFU Visit 1 year after the last dose of investigational product.During the LTFU period, all subjects will be followed by phone or in clinic every 12 weeks (± 2 weeks) from the last dose of investigational product until the end of study (EOS) visit. All subjects should complete EOS Visit up to 2 weeks after the last subject in the trial completes their LTFU Visit at 1 year after the last dose of investigational product." Placebo Arm: "This is a phase 3, randomized, placebo-controlled, multicenter, international study for the treatment of CIT in adult subjects receiving oxaliplatin-based chemotherapy for the treatment of gastrointestinal, pancreatic, or colorectal cancer. Subjects must have a platelet count ≤ 85 x 109/L on day 1 of the study. The study will consist of a screening period of up to 4 weeks, a treatment period long enough to allow for assessment of 3 planned cycles of chemotherapy, a follow-up visit, and long-term follow-up (LTFU). Given that subjects will be assessed for 3 planned cycles of chemotherapy, the oxaliplatin-based chemotherapy cycles are 2-3 weeks in duration, and the investigational product dose adjustment guidelines allow for up to 12 weeks of dosing before a subject is declared a non-responder, the majority of study subjects will receive investigational product for a range of between 7-21 weeks. Once eligibility is confirmed, subjects will be randomized on day 1 of the study in a 2 to 1 ratio to receive either romiplostim or placebo, respectively. Randomization will be stratified by tumor type and baseline platelet count (< 50 x 109/L, ≥ 50 x 109/L). Baseline platelet count is defined as platelet count measured most prior to the time of the planned investigational product administration. Gastrointestinal adenocarcinomas, including tumors of the esophagus and stomach, will be included in one stratum, pancreatic cancers in a second stratum, and colorectal cancers, including adenocarcinomas of the colon or rectum, will be included in a third stratum. Subjects will then enter the treatment period, during which time they will return to the clinic weekly for local platelet counts, undergo dose titrations as needed, and investigational product administration. If there are multiple platelet values performed on a study visit date, the platelet value from the test performed most immediately prior to the time of the planned investigational product and/or non-investigational product administration will be recorded as the platelet value for that study visit date and will be used to determine the subject’s dose of investigational product and, when applicable, chemotherapy dose modifications, which include dose reductions, delays, omissions, and discontinuations. Subjects will receive weekly subcutaneous injections of investigational product throughout the treatment period, starting at 2 microgram/kg and increasing by increments of 1 microgramg/kg to a maximum dose of 10 microgramg/kg to reach a target platelet count of≥100 x 10-*9/L. If the subject will be receiving concomitant chemotherapy on a study visit date, investigational product will be administered immediately after the completion of chemotherapy infusion on chemotherapy day 1. If continuous infusion 5-FU over 46-48 hours is part of the chemotherapy regimen the investigational product may be administered prior to beginning or during the continuous infusion 5-FU.Subjects will have a follow-up Visit 1 week after the last dose of investigational product. Subjects will have their first in-clinic LTFU Visit 30 (+5) days after the last dose of investigational product (Safety Follow-up 1). Subjects will be contacted 30 (+5) days after the last dose of the last on-study cycle of chemotherapy (up to 3 cycles) to collect adverse event information except for females who are in addition required to come to clinic for a highly sensitive urine or serum pregnancy test (Safety Follow-up 2). Subjects will remain in LTFU until the last subject in the trial completes the LTFU Visit 1 year after the last dose of investigational product.During the LTFU period, all subjects will be followed by phone or in clinic every 12 weeks (± 2 weeks) from the last dose of investigational product until the end of study (EOS) visit. All subjects should complete EOS Visit up to 2 weeks after the last subject in the trial completes their LTFU Visit at 1 year after the last dose of investigational product." |
Regulatory references
- Scientific advice from competent authorities
- The Spanish Agency Of Medicines And Medical Devices, European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Subject has provided informed consent prior to initiation of any study specific activities/procedures or subject’s legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.
- Males or females ≥ 18 years of age at signing of the informed consent.
- Histologically or cytologically confirmed diagnosis of gastrointestinal, pancreatic, or colorectal adenocarcinoma, defined as cancers of the esophagus (including esophagogastric junction [EGJ] cancer), stomach, pancreas, colon, or rectum. Tumor stage will not affect eligibility.
- Subjects must be receiving one of the following regimens: An oxaliplatin-based chemotherapy regimen, containing 5 FU or capecitabine plus oxaliplatin (irinotecan may be added for FOLFIRINOX or FOLFOXIRI) on a 14- or 21-day schedule, respectively. OR Subjects must have CIT from a non-protocol chemotherapy regimen, planning to start treatment with 1 of the above protocol chemotherapy regimens which has been delayed ≥ 1 week due to CIT. Note: Use of these regimens are permitted with (1) anti angiogenic agents (such as bevacizumab) or (2) targeted therapy (such as anti epidermal growth factor receptor agents)"
- Subjects must have a local platelet count ≤ 85 x 109/L on study day 1.
- Subjects must be at least 14 days removed from the start of the chemotherapy cycle immediately prior to study day 1 if they received FOLFOX, FOLFIRINOX or FOLFOXIRI, and 21 days removed if they received CAPEOX.
- Subjects must have at least 3 remaining planned cycles of chemotherapy at study enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Exclusion criteria 29
- Previous Medical Conditions : Acute Lymphoblastic Leukemia
- History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months of screening.
- Evidence of active infection within 2 weeks prior to first dose of study treatment.
- Known human immunodeficiency virus infection. Subjects without a documented diagnosis in their medical history will require a local laboratory assessment at screening. If local laboratory results are not available, use central laboratory results.
- Known active chronic hepatitis B or C infection. Subjects without a documented diagnosis in their medical history will require a local laboratory assessment at screening. If local laboratory results are not available, use central laboratory results. Hepatitis B and C infection is based on the following results: - Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B). - Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B.
- Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C. In addition to the conditions listed in exclusion criteria 201 to 206, secondary malignancy within the past 5 years except: - Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. - Adequately treated cervical carcinoma in situ without evidence of disease. - Adequately treated breast ductal carcinoma in situ without evidence of disease. - Prostatic intraepithelial neoplasia without evidence of prostate cancer. - Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ. - Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment and felt to be at low risk for recurrence by the treating physician (excluding malignancies listed in exclusion criteria 201 – 206).
- Thrombocytopenia due to another etiology other than CIT (eg, chronic liver disease, prior history of immune thrombocytopenia purpura).
- Previous use of romiplostim, pegylated recombinant human megakaryocyt growth and development factor, eltrombopag, recombinant human TPO, any other TPO receptor agonist, or any investigational platelet producing agent.
- Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
- Acute myeloid leukemia.
- Any myeloid malignancy.
- Myelodysplastic syndrome. Baseline bone marrow biopsy is not required to rule out MDS. However, if a bone marrow biopsy and cytogenetics were performed as part of diagnostic or staging work-up, these results will be collected to confirm.
- Myeloproliferative disease.
- Multiple Myeloma
- Within 4 months prior to enrollment, any history of active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significant electrocardiogram (ECG) abnormalities, screening ECG with corrected QT (QTc) interval of > 470 msec, pericardial disease, or myocardial infarction.
- Major surgery ≤ 28 days or minor surgery ≤ 3 days prior to enrollment.
- New or uncontrolled venous thromboembolism or thrombotic events within 3 months prior to screening. To be eligible, subjects must have received at least 14 days of anticoagulation for a new thrombotic event and considered to be both stable and suitable for continued therapeutic anticoagulation during trial participation.
- Anemia (hemoglobin < 80 g/L [8 g/dL]) on the day of initiation of investigational product as assessed by local labs. Use of red cell transfusions and erythropoietic stimulating agents is permitted throughout the study as per institutional guidelines.
- Neutropenia (absolute neutrophil count < 1 x 109/L) on the day of initiation of investigational product as assessed by local labs. Use of granulocyte-colony stimulating factor is permitted throughout the study as per institutional guidelines.
- Abnormal renal function with creatinine clearance < 30 mL/min using the Cockcroft-Gault estimated creatinine clearance as assessed by local laboratory during screening. If local laboratory results are not available, use central laboratory results.
- Abnormal liver function (total bilirubin >3 X ULN; alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3 X ULN for subjects without liver metastases or ≥ 5 X ULN for subjects with liver metastases) as assessed by local laboratory during screening. If local laboratory results are not available, use central laboratory results.
- Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 6 months after treatment (and chemotherapy) discontinuation (females of childbearing potential should only be included after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test.)
- Females of childbearing potential unwilling to use a highly effective method of contraception during treatment and for an additional 6 months after treatment (and chemotherapy) discontinuation.
- Males unwilling to use contraception* (male condom or sexual abstinence) or their female partner(s) of childbearing potential who are unwilling to use a highly effective method of contraception during treatment (and chemotherapy) and for an additional 6 months after treatment (and chemotherapy) discontinuation. *If the male’s sole partner is of non-childbearing potential, he is not required to use additional forms of contraception during the study.
- Subject has known sensitivity to any of the products to be administered during dosing.
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, COAs) to the best of the subject and investigator’s knowledge.
- History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment (and chemotherapy) and for an additional period of 6 months after treatment (and chemotherapy) discontinuation.
- Male subjects unwilling to abstain from donating sperm during treatment (and chemotherapy) and for an additional 6 months after treatment (and chemotherapy) discontinuation.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- No thrombocytopenia-induced modification of any myelosuppressive treatment agent in the second and third cycles of the planned on-study chemotherapy regimen. Thrombocytopenia-induced modifications include chemotherapy dose reduction, delay, omission, or chemotherapy treatment discontinuation due to platelet counts below 100 x 109/L
Secondary endpoints 7
- The depth of the platelet count nadir from the start of the first on-study chemotherapy cycle through the end of the treatment period
- The time to first platelet response, defined by platelet count ≥ 100 x 109/L in the absence of platelet transfusions during the preceding 7 days
- The duration-adjusted event rate of ≥ grade 2 bleeding events, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading scale
- Overall Survival
- Platelet transfusion(s) during the treatment period
- achieving a platelet count ≥ 100 x 109/L at any time after study day 1 to week 4 (ie, 7 days after the planned third dose of investigational product) and in the absence of platelet transfusions during the preceding 7 days
- Adverse events, including treatment-emergent adverse events, fatal adverse events, serious adverse events, and clinically significant changes in laboratory values. Anti-romiplostim antibodies and antibodies to thrombopoietin (TPO) myelodysplastic syndromes and secondary malignancies
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Nplate 500 micrograms powder and solvent for solution for injection
PRD386643 · Product
- Active substance
- Romiplostim
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 10 µg/Kg microgram(s)/kilogram
- Max total dose
- 210 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 21 Week(s)
- Authorisation status
- Authorised
- ATC code
- B02BX04 — -
- Marketing authorisation
- EU/1/08/497/007
- MA holder
- AMGEN EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amgen Inc.
- Sponsor organisation
- Amgen Inc.
- Address
- 1 Amgen Center Drive
- City
- Thousand Oaks
- Postcode
- 91320-1799
- Country
- United States
Scientific contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Public contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| PPD Development LP ORG-100011560
|
Richmond, United States | Other |
| Q Squared Solutions Limited ORG-100042527
|
Reading, United Kingdom | Laboratory analysis |
| Medical Equipment Supplies And Management Limited ORG-100044212
|
Chorley, United Kingdom | Other |
| Clariness GmbH ORG-100045306
|
Hamburg, Germany | Other |
| Wuxi Apptec Co. Ltd. ORG-100012470
|
Shanghai, China | Other |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Excelya Greece CRO Single Member S.A. ORG-100009224
|
Vrilissia, Greece | On site monitoring |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Reify Health ORL-000000515
|
Boston, United States | Other |
Locations
8 EU/EEA countries · 28 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 8 | 1 |
| France | Ended | 10 | 4 |
| Greece | Ended | 8 | 5 |
| Italy | Ended | 7 | 2 |
| Poland | Ended | 8 | 3 |
| Portugal | Ended | 6 | 4 |
| Romania | Ended | 8 | 4 |
| Spain | Ended | 5 | 5 |
| Rest of world
Ukraine, Brazil, Argentina, Mexico, United States, Colombia, Russian Federation, Canada, Peru
|
— | 94 | — |
Investigational sites
Complex Oncology Center Ruse EOOD
Department of Medical Oncology, 2 Nezavisimost street, 7000, Ruse
Hospital Foch
ONCOLOGY, 40 Rue Worth, 92150, Suresnes
Institut Gustave Roussy
ONCOLOGY, 114 Rue Edouard Vaillant, 94800, Villejuif
Assistance Publique Hopitaux De Paris
ONCOLOGY, 20 Rue Leblanc, 75015, Paris
Centre Hospitalier Regional Et Universitaire De Brest
ONCOLOGY, 5 Avenue Marechal Foch, Bp 824, Brest Cedex 2
General University Hospital Of Patras
Division of Oncology, Rio, 265 04, Patras
Areteio Hospital
Oncology Unit, B Surgery Clinic, Vassilissas Sofias Avenue 76, 115 28, Athens
St. Luke's Hospital S.A.
Oncology Department, Harilaou Trikoupi Str. 3, 552 36, Thessaloniki
Evgenidion Clinic Agia Trias S.A.
Oncology Department, Papadiamadopoulou 20, 115 28, Athens
University General Hospital Attikon
2nd Propaedeutic Pathology Clinic, Rimini Street 1, 124 62, Athens
Azienda Istituti Ospitalieri Di Cremona
Department of Oncology, Viale Concordia 1, 26100, Cremona
ASST Grande Ospedale Metropolitano Niguarda
Department of Hematology and Oncology, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Uniwersytecki Szpital Kliniczny W Poznaniu
Hematology, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Powiatowe Centrum Zdrowia W Brzezinach Sp. z o.o.
Hematology, Ul. Marii Sklodowskiej-Curie 6, 95-060, Brzeziny
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
Hematology, Ul. Terebelska 57/65, 21-500, Biala Podlaska
Unidade Local De Saude De Matosinhos E.P.E.
Servico de Oncologia, Rua Doutor Eduardo Torres, 4464-513, Senhora Da Hora
Unidade Local De Saude De Santa Maria E.P.E.
Servico de Oncologia Medica, Avenida Professor Egas Moniz, 1649-035, Lisbon
Centro Hospitalar De Tras-Os-Montes E Alto Douro E.P.E.
Servico Oncologia, Avenida Da Noruega, 5000-508, Vila Real
Unidade Local de Saude de Sao Joao E.P.E.
Servico de Oncologia Medica, Alameda Professor Hernani Monteiro, 4200-319, Porto
CF Clinical Hospital
Oncology, Strada Republicii 18, 400015, Cluj-Napoca
Medisprof S.R.L.
Oncology, Bulevardul Muncii 96, 400641, Cluj-Napoca
Oncomed S.R.L.
Oncology, Strada Porumbescu Ciprian Nr 59, 300239, Timisoara
Institutul Clinic Fundeni
Oncology, Soseaua Fundeni 258, 022328, Bucharest
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Servicio de Oncología Médica, Avinguda De L'alcalde Rovira Roure 80, 25196, Lleida
Salut Sant Joan De Reus
Servicio de Oncología Médica, Avinguda Del Doctor Josep Laporte 2, 43204, Reus
Complejo Hospitalario Universitario De Ourense
Servicio de Oncología Médica, Calle De Ramon Puga Noguerol Nº 52, 32005, Ourense
Hospital Universitario Hm Sanchinarro
Servicio de Oncología Médica, Calle Ona 10, 28050, Madrid
Hospital Universitario Clinico San Cecilio
Servicio de Oncología Médica, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Bulgaria | 2020-07-03 | 2025-01-07 | 2020-07-06 | ||
| France | 2021-03-08 | 2023-11-30 | 2021-06-25 | 2023-11-30 | |
| Greece | 2019-10-03 | 2025-01-08 | 2019-11-21 | 2024-01-12 | |
| Italy | 2020-01-23 | 2024-12-27 | 2020-03-13 | 2023-12-01 | |
| Poland | 2019-11-08 | 2024-10-31 | 2020-10-08 | 2023-12-21 | |
| Portugal | 2020-07-27 | 2025-01-09 | 2020-07-31 | 2023-11-14 | |
| Romania | 2020-01-30 | 2024-12-30 | 2020-07-03 | 2023-12-12 | |
| Spain | 2019-12-12 | 2025-01-09 | 2020-01-15 | 2023-11-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Romiplostim_20140346_Technical Results Summary_Final Analysis SUM-110384
|
2025-12-12T13:45:34 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Romiplostim_20140346_Final Summary of Results_Plain Language Summary | 2025-12-12T13:45:51 | Submitted | Laypersons Summary of Results |
Documents 88 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Romiplostim_20140346_Final Summary of Results_Plain Language Summary_BG | 1 |
| Laypersons summary of results (for publication) | Romiplostim_20140346_Final Summary of Results_Plain Language Summary_EN | 1 |
| Laypersons summary of results (for publication) | Romiplostim_20140346_Final Summary of Results_Plain Language Summary_ES | 1 |
| Laypersons summary of results (for publication) | Romiplostim_20140346_Final Summary of Results_Plain Language Summary_GR | 1 |
| Laypersons summary of results (for publication) | Romiplostim_20140346_Final Summary of Results_Plain Language Summary_IT | 1 |
| Laypersons summary of results (for publication) | Romiplostim_20140346_Final Summary of Results_Plain Language Summary_PL | 1 |
| Laypersons summary of results (for publication) | Romiplostim_20140346_Final Summary of Results_Plain Language Summary_PT | 1 |
| Laypersons summary of results (for publication) | Romiplostim_20140346_Final Summary of Results_Plain Language Summary_RO | 1 |
| Protocol (for publication) | D1_Protocol_ENG_2023-507148-35_20140346_For Publication | 5 |
| Recruitment arrangements (for publication) | K_Recruitment arrangement_dummy document_for publication | 1.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_For Publication | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_Dummy_For Publication | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_For Publication | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_For Publication | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_For Publication | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_For Publication | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Patient flyer | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Doctor to Doctor Letter_For Publication | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Dosing Guide_For Publication | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dosing Guide_For Publication | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dosing guide_FP | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dr to Dr refferal letter_For publication | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Information given to trial subjects_Patient Flyer_For Publication | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Flyer EU Subject Facing_For publication | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Flyer_For Publication | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Flyer_For Publication | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Flyer_FP | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Visit Guide_For Publication | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Visit Tool_For Publication | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient visit Tool_FP | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Site visit Tool_FP | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Study Guide_For Publication | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Guide_For Publication | 5.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study guide_FP | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Team Visit Guide_For Publication | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Study Visit Guide_For Publication | 4 |
| Recruitment arrangements (for publication) | K2_recrutiment material_Patient Flyer_For Publication | 4 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Adults Main_For Publication | 13.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Pregnancy FUP_Father_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Pregnancy FUP_Mother_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Withdrawal_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Informed consent procedure | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main Study_For publication | 12.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_For Publication | 13 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_English_For Publication | 13.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_French_For Publication | 11.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_French_Romiplostim_For Publication | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_Translation Bulgarian_For Publication | 13.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research | 11.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research_For Publication | 12 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main | 11.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main EN_FP | 13.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main RO_ FP | 13.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Patient Information Sheet EU CTR_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_For Publication | 13.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Initial Pregnancy Mother-Partner Authorization Form_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_For Publication | 13.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Partial Withdrawal of ICF Future Research_For Publication | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Partial Withdrawal of ICF Main_For Publication | 3.1 |
| Subject information and informed consent form (for publication) | L1_Site specific SIS and ICF adults_BG_VYordanov_KOC-Ruse_For Publication | 11.1 |
| Subject information and informed consent form (for publication) | L2_ Informed Consent Procedure_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_Informed Consent Procedure_Dummy | 1 |
| Subject information and informed consent form (for publication) | L2_Informed Consent Procedure_For Publication | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Patient Sheet_EN_FP | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Patient Sheet_RO_FP | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Patient information sheet_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GP Letter_For Publication | 7.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Informed Consent Procedure_For Publication | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Informed consent procedure_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Informed consent procedure_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card_For Publication | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Information Sheet_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject information sheet_Bulgarian_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject information sheet_English_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_Subject information sheet_Spanish_For Publication | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Fluorouracil_For Publication | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Nplate_For Publication | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Oxaliplatin Medac_For Publication | 1 |
| Summary of results (for publication) | Romiplostim_20140346_Technical Results Summary_Final Analysis | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BG_2023-507148-35_20140346_For Publication | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES_2023-507148-35_20140346_For Publication | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_2023-507148-35_20140346_For Publication | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_GR_2023-507148-35_20140346_For Publication | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2023-507148-35_20140346_For Publication | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PL_2023-507148-35_20140346_For Publication | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_RO_2023-507148-35_20140346_For Publication | 1 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-06 | Spain | Acceptable 2023-11-13
|
2023-11-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-05 | Spain | Acceptable 2023-11-13
|
2024-03-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-25 | Acceptable | 2024-06-03 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-05 | Spain | Acceptable 2024-10-29
|
2024-10-31 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-06-26 | Spain | Acceptable 2024-10-29
|
2025-06-26 |