Malignant pleural mesothelioma MedDRA version: 11.1 Level: LLT Classification code 10027406 Term:
Conditions
Interventions
Product Name: VINFLUNINE DITARTRATE
Product Code: L00070
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Vinflunine ditartrate
Current Sponsor code: L00070
Concentration unit: mg milligram(s)
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically proven diagnosis of malignant pleural mesothelioma. 2. Only one prior systemic chemotherapy regimen that included pemetrexed with a platinum analogue. A minimum interval of 4 weeks should have elapsed between the last administration of chemotherapy and study entry 3. Documented progressive disease that occurs during or after first-line chemotherapy. Patients must have received at least 2 cycles of first-line chemotherapy. 4. Presence of at least one measurable target lesion according to modified RECIST. 5. Male or female at least 18 years of age 6. Performance status 0, 1 or 2 7. No radiotherapy for 3 weeks ; at least 2 weeks for pleurodesis, targeted therapy and immunotherapy 8. Adequate bone marrow function defined as : - Haemoglobin >or=10 g/dL - Absolute neutrophil count >1.5 x 10 9/L - Platelet count >100 x 10 9/L 9. Adequate liver function tests defined as total bilirubin or= 50 mL/min according to Cockroft and Gault formula. 11. Women of childbearing potential must be using a medically accepted method of contraception (i.e. oral contraceptives, intrauterine devices) to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment in such a manner that the risk of pregnancy is minimized. Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the start of study treatment 12. Fertile men must be using an effective method of birth control if their partners are women of childbearing potential 13. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial 14. The patient must give written (personally signed and dated) informed consent before completing any study-related procedure which means assessment or evaluation that would not form part of the normal medical care of the patient 15. Ability to swallow capsules 16. The patient must have access to a social insurance according to local regulations. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. A female is not eligible to enter the study if : - Pregnant or lactating - With positive pregnancy test at inclusion 2. Male or female of childbearing potential who is unwilling or unable to use a medically accepted method to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and at least 3 months following the last dose of study treatment 3. Known hypersensitivity to the study drug or to drugs with similar chemical structures 4. History of CNS metastases, unless the patient has been previously treated for CNS metastases, is stable for at least 4 weeks by CT scan without evidence of cerebral oedema, and has no requirement for corticosteroids or anticonvulsivants 5. Patients with any underlying medical condition that might be aggravated by treatment or which cannot be controlled i.e active serious infection, diabetes mellitus, concurrent heart failure [New York Heart Association (NYHA) class III-IV] or with progressive or unstable angina, myocardial infarction within 6 months, and/or poorly controlled hypertension, or pericardial effusion 6. History of significant neurologic or psychiatric disorders, precluding understanding and giving of informed consent 7. History of other cancers with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin or other cancer curatively treated with surgery and/or radiotherapy and with no evidence of disease for at least 5 years 8. Grade = 2 peripheral neuropathy at study entry according to NCI-CTC AE (version 3.0) 9. Prior extensive radiotherapy up to more than 25% of bone marrow reserve 10. Prior treatment with a vinca alkaloid 11. Patients with grade = 2 dysphagia; 12. Participation into a clinical study of an investigational agent within 28 days before study entry 13. Concurrent treatment with any other anti-cancer therapy except bisphosphonates 14. Any alteration of gastro-intestinal tract likely to impact on absorption and elimination of oral drugs like: - malabsorption syndrome - extensive surgery of the stomach or the small bowel - major alterations of gastro intestinal transit such as subocclusive syndrome whatever the aetiology.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the overall survival (OS) in the oral VFL plus best supportive care (BSC) arm versus the placebo plus best supportive care (BSC) arm.;Secondary Objective: - To evaluate the response rate and response duration in the 2 study arms, - To assess the progression-free survival in the 2 study arms, - To assess the safety profile of oral VFL plus BSC in comparison with the control arm, - To compare the change in disease-related symptoms in the 2 study arms.;Primary end point(s): The primary efficacy endpoint will be the overall survival defined as time from randomisation to death or last follow-up. | — |
Countries
France
Outcome results
None listed