The trial concerns patients suffering from advanced or metastatic Transitional Cell Carcinoma of the Urothelium (TCCU) who are unfit for Cisplatin-containing first-line treatment due to reduced renal function (GFR 30-60 mL/min) MedDRA version: 18.0 Level: LLT Classification code 10046722 Term: Urothelial carcinoma bladder stage IV System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Javlor®
Product Name: Javlor
Product Code: L0070
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: VINFLUNINE
CAS Number: 162652-95-1
Concentration unit: mg/m
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed diagnosis of locally advanced or metastatic predominantly transitional cell carcinoma of the urothelium (TCC) [urinary bladder, kidney, renal pelvis, or ureter], - Man or woman aged > or equal to 18 years and or equal to 6 months after the last dose of chemotherapy, - Adequate bone marrow and hepatic functions as evidenced by: o Absolute Neutrophil Count > or equal to 2.0 x 10(9)/L, Platelet count > or equal to 100 x 10(9)/L, Haemoglobin > or equal to 10.0 g/dL o Serum total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 81
Exclusion criteria
Exclusion criteria: - ECOG performance status > or equal to 2, - Calculated creatinine clearance or equal to 2 by National Cancer Institute Common Toxicity Criteria [NCI CTC], - Prior radiation to > or equal to 30% of the bone marrow or completed or equal to 5 years, - Patients who require treatment with ketoconazole, itraconazole, ritonavir, amprenavir, indinavir, rifampicine (any potent CYP3A4 inhibitor or inducer), phenytoine ormedicinal products known to prolong QT/QTc interval, - Known hypersensitivity to the study drugs or to drugs with similar chemical structures, - Any previous organ allograft or any chronic system disease requiring concurrent immune therapy, - Woman if pregnant or lactating or with positive pregnancy test at inclusion; woman of child-bearing potential who did not use or is unwilling or unable to use an acceptable method to avoid pregnancy during the 2 months preceding the start of study treatment, for the entire study period and for up to 6 months after the last dose of study treatment, - Sexually active fertile man not using effective birth control during the study and up to 6 months after the last dose of study treatment if his partner is a woman of childbearing potential.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the median Progression Free Survival without related Severe Acute Toxicity* between arms (called SAT-PFS). *[enlarged definition of the Severe Acute Toxicity (SAT) from the EORTC study 30986 adding vinflunine specific risks: neutropenia G4 > 7 days, neutropenic fever G3/4, neutropenic systemic sepsis G3/G4 (neutropenia G3/4), G3/G4 thrombocytopenia with bleeding, G3/4 renal toxicity, G3/4 mucositis, constipation G4 requiring surgery, and death].;Secondary Objective: - To evaluate the Disease Control Rate (DCR) and the Objective Response Rate (ORR), - To estimate the Duration of Response of Disease Control and of Stable Disease, - To estimate the Progression-Free Survival (PFS), Time To Treatment Failure (TTF), - To estimate the Overall Survival (OS). - To assess the Tolerance. - To assess the Quality of Life.;Primary end point(s): The primary endpoint is to compare the median Progression Free Survival without related Severe Acute Toxicity* between arms (called SAT-PFS).;Timepoint(s) of evaluation of this end point: Tumour assessment will be performed according to the RECIST guideline (version 1.1). Assessment of measurable and non-measurable disease will be carried out at baseline and every 6 weeks until disease progression. Survival data and post-study treatments will be reported every 3 months after progression. Progression and tumour response will be evaluated for all randomized patients by the investigators. Duration of disease control and response will be evaluated for all patients with disease control and responding patients, respectively. Moreover, clinical parameters such as pain intensity will be assessed every 2 cycles. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To evaluate the Disease Control Rate (DCR) and the Objective Response Rate (ORR), - To estimate the Duration of Response of Disease Control and of Stable Disease, - To estimate the Progression-Free Survival (PFS), Time To Treatment Failure (TTF), - To estimate the Overall Survival (OS). - To assess the Tolerance. - To assess the Quality of Life.;Timepoint(s) of evaluation of this end point: as timepoints for primary endpoint evaluation | — |
Countries
Austria, Czech Republic, France, Italy, Poland, Spain, Taiwan, United Kingdom
Contacts
Public ContactResponsable ensayos clínicos intern
Pierre Fabre Ibérica, S. A.
Outcome results
None listed