Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
92
Countries
1
Sites
1
relapsing vulvar carcinoma already subjected to multiple treatments
The primary objective of this study is to evaluate whether BLM + AUC2-CARBOPLATIN is superior to BLM alone in terms of local progression-free survival (LPFS) in women with relapsed VC after multimodal treatments (surgery and radiotherapy/chemoradiation)
Key facts
- Sponsor
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-11-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- IRCCS AOUBO Policlinico di S.Orsola (donation Associazione Loto Onlus)
External identifiers
- EU CT number
- 2024-518370-14-00
- EudraCT number
- 2021-002614-13
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy
The primary objective of this study is to evaluate whether BLM + AUC2-CARBOPLATIN is superior to BLM alone in terms of local progression-free survival (LPFS) in women with relapsed VC after multimodal treatments (surgery and radiotherapy/chemoradiation)
Secondary objectives 1
- - To compare Health-Related Quality of life (HR-QoL) in patients undergoing BLM + AUC2-CARBOPLATIN vs BLM alone assessed with questionnaires (FACT-V, FACIT-PAL, E5-5L-D5). - To compare the tumor response rates in patients undergoing BLM + AUC2-CARBOPLATIN vs BLM alone (based on RECIST 1.1 criteria). - To compare OS in the two study arms. - To compare local and systemic toxicity, morbidity and mortality, intraoperative and post-operative complications among the two study arms. - To compare costs and cost-effectiveness between the two study arms.
Conditions and MedDRA coding
relapsing vulvar carcinoma already subjected to multiple treatments
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10026642 | Malignant neoplasm of vulva recurrent | 10029104 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Overall trial Randomization with equal probability of assignment to each treatment regimen
|
Randomised Controlled | None | Arm A: Arm A (experimental arm): patients will receive intravenous administration of BLM + AUC2-CARBOPLATIN Arm B: Arm B (reference arm): patients will receive intravenous administration of BLM alone |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- - Age ≥ 18 years old - Recurrent VC confirmed by histological examination - Patient who underwent multiple treatments (surgery and radiation therapy or chemoradiation, radiation therapy or chemoradiation and chemotherapy). - Patient not eligible for standard therapies (surgery, radiation therapy and systemic chemotherapy in case of metastatic disease) due to the performance status (ECOG Performance Status ≥ 3 ) - Life expectancy more than three months - Measurable disease according to RECIST 1.1 - Adequate bone marrow, liver, and kidney function (creatinine <1.5 mg/dl), and coagulation parameters as follows: o Bone marrow (Hemoglobin ≥ 8.0 g/dL with or without transfusion support, Platelet count ≥ 75 × 109/L?) o INR >1.5; o Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvate transaminase (SGPT) ≤3.0 × upper limit of normal (ULN) o Total bilirubin ≤2.0 × ULN or ≤3 × ULN except for subjects with Gilbert’s syndrome o Serum creatinine <1.5 mg/dl and creatinine clearance > 30 ml/min All blood assessments must be performed within 15 days from ECT treatment. - For females of childbearing potential, a negative serum pregnancy human chorionic gonadotropin (hCG) pregnancy test within 72 hours of study Day 1. - Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient’s awareness and willingness to comply the study requirements.
Exclusion criteria 1
- - History of other malignancies in the previous five years, except basal cell carcinoma of the skin. - History of psychological, familial, sociological, or geographical condition potentially preventing compliance with the study protocol and follow-up schedule. - Allergic reactions to the two chemotherapy drugs (BLM and AUC2-CARBOPLATIN) and/or their excipients. - Evidence of pulmonary fibrosis. - History of clinically significant cardiovascular abnormalities such as congestive heart failure (New York Heart Association classification ≥ II [NYHA 1994]), myocardial infarction within 6 months of study entry. - Patients requiring treatment for systemic bacterial, fungal, or viral infection ongoing at the day of the procedure. (Patients on antimicrobial, antifungal, or antiviral prophylaxis are not excluded). - Pregnant or breastfeeding. - Disability to understand and complete the questionnaire due to language difficulties, severe psychiatric illness or dementia. Unstable or severe uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the Investigator’s judgment, increase the risk to the patient associated with his or her participation in the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- local progression free survival
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Carboplatino AHCL 10 mg/ml Concentrato per soluzione per infusione
PRD11440570 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 70 mg/m2 milligram(s)/square meter
- Max total dose
- 140 mg/m2 milligram(s)/square meter
- Max treatment duration
- 4 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 039263013
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
BLEOPRIM 15 mg polvere per soluzione iniettabile
PRD431183 · Product
- Active substance
- Bleomycin Sulfate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 15 mg/m2 milligram(s)/square meter
- Max total dose
- 30 mg/m2 milligram(s)/square meter
- Max treatment duration
- 4 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01DC01 — BLEOMYCIN
- Marketing authorisation
- 022395026
- MA holder
- SANOFI S.R.L.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Sponsor organisation
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Address
- Via Pietro Albertoni 15
- City
- Bologna
- Postcode
- 40138
- Country
- Italy
Scientific contact point
- Organisation
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Contact name
- Anna Myriam Perrone
Public contact point
- Organisation
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Contact name
- Barbara Lotito
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Authorised, recruitment pending | 92 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2021-002614-13_FP | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_placeholder_FP | 1 |
| Subject information and informed consent form (for publication) | L1_GP LETTER_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_data_protection_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_participation_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS_data_protection_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_participation_FP | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_BLEOPRIM | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_CARBOPLATINO AHCL | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2021-002614-13_EN_FP | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2021-002614-13_IT_FP | 2.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-14 | Italy | Acceptable 2024-11-07
|
2024-11-27 |