Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
84
Countries
1
Sites
8
Endometrial cancer
To evaluate effectiveness of a single oral dose of NEPA in terms of complete response (CR: no emesis, no rescue medication) in the overall phase (0-120h) at cycle 1 in chemotherapy-naïve patients with endometrial cancer receiving paclitaxel and carboplatin with or without immunotherapy.
Key facts
- Sponsor
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
- Trial duration
- 21 Feb 2024 → ongoing
- Decision date (initial)
- 2023-11-07
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Italfarmaco S.p.A.
External identifiers
- EU CT number
- 2023-504150-35-00
- WHO UTN
- U0000-0000-0000
- ClinicalTrials.gov
- NCT00000000
- ISRCTN
- ISRCTN00000000
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
To evaluate effectiveness of a single oral dose of NEPA in terms of complete response (CR: no emesis, no rescue medication) in the overall phase (0-120h) at cycle 1 in chemotherapy-naïve patients with endometrial cancer receiving paclitaxel and carboplatin with or without immunotherapy.
Secondary objectives 5
- Effectiveness of a single oral dose of NEPA in terms of CR and complete control (CC: no rescue medication, no emesis and no nausea (VAS score of <25 mm) during the acute (0-24 hours), delayed (>24 to 120 hours), and overall (0-120 hours) phases after the start of chemotherapy of each cycle.
- Effectiveness of a single dose of NEPA in terms of no rescue medication, no emesis and no significant nausea (VAS score of <25 mm) during the acute (0-24 hours), delayed (>24 to 120 hours), and overall (0-120 hours) after the start of chemotherapy of each cycle.
- Effectiveness of a single oral dose of NEPA in terms of CR and complete control during the acute (0-24 hours), delayed (>24 to 120 hours), and overall (0-120 hours) phases after the start of each cycle according to Patient Emetogenicity Risk Profile assessed with CINV Risk Assessment tool in patients with endometrial cancer receiving paclitaxel and carboplatin regimen with or without immunotherapy.
- To evaluate safety of NEPA when given in multiple treatment cycles in patients with endometrial cancer receiving paclitaxel and carboplatin with or without immunotherapy.
- To evaluate QoL of patients with endometrial cancer treated with paclitaxel and carboplatin regimen receiving NEPA as antiemetic treatment in terms of FLIE scores during each cycle.
Conditions and MedDRA coding
Endometrial cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10008448 | Chemotherapy induced emesis prophylaxis | 10042613 |
| 21.1 | LLT | 10008449 | Chemotherapy inducted emesis prophylaxis | 10042613 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Subject is at least 18 years of age, able to understand the study procedures, and agrees to participate in the study by providing written informed consent.
- Subject has histologically or cytologically proven endometrial cancer.
- Patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Adequate organ function allowing the patient to receive taxane-platinum combination therapy with or without immunotherapy according to clinical practice and opinion of treating physician.
- Naive to chemotherapy.
Exclusion criteria 8
- Patients will experience emesis within the 24 hours before receipt of 1 course of chemotherapy.
- Patients will be scheduled to radiation therapy to the abdomen or pelvis within 1 week before day 1 or between day 1 and 5.
- Patients will be scheduled to undergo bone marrow or stem-cell transplant.
- Chronic systemic corticosteroid use.
- Brain metastasis.
- Subject is considered a poor medical risk due to a serious, uncontrolled medical disorder.
- History or predisposition to cardiac conduction abnormalities, torsade des pointes or severe cardiovascular diseases.
- Subject is pregnant or breastfeeding or is expecting to conceive children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of study treatment.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Proportion of patients achieving complete response (CR: no emesis, no rescue medication) during the overall phase (0-120h) at cycle 1.
Secondary endpoints 4
- Proportion of patients achieving a complete response and complete control during the acute (0–24 h), delayed phase (>24 to 120 h) and overall (0-120h) phases of each cycle after the start of chemotherapy.
- Proportion of patients achieving no rescue medication, no emesis and no significant nausea (VAS score of <25 mm) during the acute (0-24 hours), delayed (>24 to 120 hours), and overall (0-120 hours) after the start of chemotherapy of each cycle.
- Proportion of patients achieving CR and complete control during the acute (0-24 hours), delayed (>24 to 120 hours), and overall (0-120 hours) phases after the start of each cycle according to Patient Emetogenicity Risk Profile assessed with 10 CINV Risk Assessment tool in patients with endometrial cancer receiving paclitaxel and carboplatin regimen with or without immunotherapy.
- The safety and tolerability of study drug (NEPA) will be evaluated based on AE reports, physical examination results (including vital signs), and clinical laboratory results by means of the occurrence, nature and severity of AEs.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
Akynzeo 300 mg/0.5 mg hard capsules
PRD2825038 · Product
- Active substance
- Palonosetron
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 1 U unit(s)
- Max total dose
- 1 U unit(s)
- Max treatment duration
- 4 Day(s)
- Authorisation status
- Authorised
- ATC code
- A04AA55 — -
- Marketing authorisation
- EU/1/15/1001/001
- MA holder
- HELSINN BIREX PHARMACEUTICALS LTD.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Akynzeo 300 mg/0.5 mg hard capsules
PRD3492024 · Product
- Active substance
- Palonosetron
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 1 U unit(s)
- Max total dose
- 1 U unit(s)
- Max treatment duration
- 4 Day(s)
- Authorisation status
- Authorised
- ATC code
- A04AA55 — -
- Marketing authorisation
- EU/1/15/1001/001
- MA holder
- HELSINN BIREX PHARMACEUTICALS LTD.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Akynzeo 300 mg/0.5 mg hard capsules
PRD3492074 · Product
- Active substance
- Palonosetron
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 1 U unit(s)
- Max total dose
- 1 U unit(s)
- Max treatment duration
- 4 Day(s)
- Authorisation status
- Authorised
- ATC code
- A04AA55 — -
- Marketing authorisation
- EU/1/15/1001/001
- MA holder
- HELSINN BIREX PHARMACEUTICALS LTD.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Akynzeo 300 mg/0.5 mg hard capsules
PRD3492125 · Product
- Active substance
- Palonosetron
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 1 U unit(s)
- Max total dose
- 1 U unit(s)
- Max treatment duration
- 4 Day(s)
- Authorisation status
- Authorised
- ATC code
- A04AA55 — -
- Marketing authorisation
- EU/1/15/1001/001
- MA holder
- HELSINN BIREX PHARMACEUTICALS LTD.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 10
Paclitaxel Kabi 6 mg/ml concentrato per soluzione per infusione
PRD2058281 · Product
- Active substance
- Paclitaxel
- Substance synonyms
- ONCOGEL, ABI-007, MBT 0206
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 175 mg/m2 milligram(s)/sq. meter
- Max total dose
- 175 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 4 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- 039405055
- MA holder
- FRESENIUS KABI ITALIA S.R.L.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
CARBOPLATINO Pfizer 10 mg/ml soluzione per infusione
PRD411761 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 400 mg/m2 milligram(s)/sq. meter
- Max total dose
- 400 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 4 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 032776039
- MA holder
- PFIZER ITALIA S.R.L.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
JEMPERLI 500 mg concentrate for solution for infusion
PRD8877508 · Product
- Active substance
- Dostarlimab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FF07 — -
- Marketing authorisation
- EU/1/21/1538/001
- MA holder
- GLAXOSMITHKLINE (IRELAND) LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323105 · Product
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Tecentriq 1 200 mg concentrate for solution for infusion
PRD5434939 · Product
- Active substance
- Atezolizumab
- Substance synonyms
- RO5541267
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FF05 — -
- Marketing authorisation
- EU/1/17/1220/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Decadron “4 mg/1 ml Soluzione iniettabile”
PRD7535050 · Product
- Active substance
- Dexamethasone Phosphate
- Substance synonyms
- DEXAMETHASONE 21-(DIHYDROGEN PHOSPHATE)
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTABLE SOLUTION
- Max daily dose
- 12 mg milligram(s)
- Max total dose
- 12 mg milligram(s)
- Max treatment duration
- 4 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 014729204
- MA holder
- I.B.N. SAVIO S.R.L.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ogivri 150 mg powder for concentrate for solution for infusion
PRD11000552 · Product
- Active substance
- Trastuzumab
- Substance synonyms
- PF-05280014, TX05, BP02, ABP-980, SYD-977
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENUS USE
- Max daily dose
- 21 mg/ml milligram(s)/millilitre
- Max total dose
- 21 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FD01 — -
- Marketing authorisation
- EU/1/18/1341/001
- MA holder
- BIOSIMILAR COLLABORATIONS IRELAND LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ogivri 420 mg powder for concentrate for solution for infusion
PRD11000556 · Product
- Active substance
- Trastuzumab
- Substance synonyms
- PF-05280014, TX05, BP02, ABP-980, SYD-977
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 21 mg/ml milligram(s)/millilitre
- Max total dose
- 21 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FD01 — -
- Marketing authorisation
- EU/1/18/1341/002
- MA holder
- BIOSIMILAR COLLABORATIONS IRELAND LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
IMFINZI 50 mg/mL concentrate for solution for infusion.
PRD6651400 · Product
- Active substance
- Durvalumab
- Substance synonyms
- MEDI4736
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 50 mg/ml milligram(s)/millilitre
- Max total dose
- 50 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FF03 — -
- Marketing authorisation
- EU/1/18/1322/002
- MA holder
- ASTRAZENECA AB
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
IMFINZI 50 mg/mL concentrate for solution for infusion.
PRD6651398 · Product
- Active substance
- Durvalumab
- Substance synonyms
- MEDI4736
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 50 mg/ml milligram(s)/millilitre
- Max total dose
- 50 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FF03 — -
- Marketing authorisation
- EU/1/18/1322/001
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fondazione IRCCS Istituto Nazionale Dei Tumori
- Sponsor organisation
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Address
- Via Giacomo Venezian 1
- City
- Milan
- Postcode
- 20133
- Country
- Italy
Scientific contact point
- Organisation
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Contact name
- Dr. Monika Ducceschi
Public contact point
- Organisation
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Contact name
- Public Relation Office
Locations
1 EU/EEA country · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 84 | 8 |
| Rest of world | — | 0 | — |
Investigational sites
Alessandro Manzoni Hospital
Oncologia Medica, Via Dell' Eremo 9, 23900, Lecco
European Institute Of Oncology S.r.l.
Ginecologia Oncologica, Via Giuseppe Ripamonti 435, 20141, Milan
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Ostetricia e Ginecologia, Corso Bramante 88, 10126, Turin
Istituto Oncologico Veneto
UOC Oncologia 2, Via Gattamelata 64, 35128, Padova
Centro Di Riferimento Oncologico Di Aviano
Oncologia Medica, Via Franco Gallini 2, 33081, Aviano
Azienda Ospedaliera Ordine Mauriziano Di Torino
SCDU Ginecologia ed Ostetricia, Via Ferdinando Magellano 1, 10128, Turin
Fondazione IRCCS Istituto Nazionale Dei Tumori
Ginecologia Oncologica, Via Giacomo Venezian 1, 20133, Milan
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Ostetricia e Ginecologia, Piazzale Spedali Civili 1, 25123, Brescia
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 |
|---|---|---|---|---|---|
| Italy | 2024-02-21 | 2024-02-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 20 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-504150-35_redacted | 1 |
| Protocol (for publication) | D1_Protocol 2023504150-35_Clean_redacted | 4 |
| Protocol (for publication) | D1_Protocol 2023504150-35_TC_redacted | 4 |
| Protocol (for publication) | D4_Patient Questionnaire-Diary | 2 |
| Protocol (for publication) | Protocol Signature Page_red | 3.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | 1 |
| Subject information and informed consent form (for publication) | L1_Informativa e ICF_Clean_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_Informativa e ICF_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Informativa e ICF_redacted | 4 |
| Subject information and informed consent form (for publication) | L1_Informativa e ICF_TC_redacted | 3 |
| Subject information and informed consent form (for publication) | L2_Informativa e ICF privacy_Clean_redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Informativa e ICF privacy_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Informativa e ICF privacy_TC_redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Lettera MMG_redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Lettera MMG_redacted | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC akynzeo | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC akynzeo_EN | 1 |
| Synopsis of the protocol (for publication) | D1_Synopsis 2023-504150-35_redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Synopsis 2023504150-35_Clean_redacted | 4 |
| Synopsis of the protocol (for publication) | D1_Synopsis 2023504150-35_TC_redacted | 4 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-19 | Italy | Acceptable 2023-10-16
|
2023-11-07 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-05 | Italy | Acceptable 2023-10-16
|
2024-03-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-28 | Italy | Acceptable 2024-08-05
|
2024-08-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-18 | Italy | Acceptable 2025-05-12
|
2025-05-19 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-01 | Italy | Acceptable 2025-05-12
|
2025-12-01 |