Advanced or metastatic predominantly transitional cell carcinoma of the urothelial tract. MedDRA version: 16.1 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: L00070
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: VINFLUNINE
CAS Number: 162652-95-1
Current Sponsor code: L0
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged = 18 years 2) Histologically confirmed diagnosis of locally advanced or metastatic predominantly transitional cell carcinoma of the urothelium (TCCU) [urinary bladder, kidney, renal pelvis, or ureter]. Not amenable to definitive local/regional therapy. 3) Stable Disease, Partial Response or Complete Response as outcome of 1st line treatment with the gemcitabine-cisplatin combination for advanced/metastatic TCCU (confirmed or not). 4) Completion of 4 cycles of 1st line treatment with the gemcitabine-cisplatin combination for the chemo-naïve advanced/metastatic TCCU patient and no persistence of any adverse event > Grade 1 related to this treatment. 5) Last administration of gemcitabine and cisplatin (i.e. last day of administration of both compounds) = 6 weeks before registration. 6) The patient must give written (personally signed and dated) informed consent before completing any study-related procedure which means any assessment or evaluation that would not be part of the routine medical care of the patient. 7) Women of childbearing potential must be using a medically accepted method of contraception (i.e. hormonal 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 minimised. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment. 8) Fertile men must be using an effective method of birth control, if their partners are women of childbearing potential, during the study period and up to 3 months after last administration of study medication. 9) ECOG performance status of 0 or 1 (patients aged = 80 years with ECOG performance status 1 or ECOG performance status 0 and prior irradiation of the pelvic area are not eligible) 10) Estimated life expectancy of at least 3 months 11) Adequate haematological, renal and hepatic functions as evidenced by: - Absolute Neutrophil Count = 1,500/mm³ (=1.5 x 10^9/L) - Haemoglobin = 9 g/dL - Platelet count = 100,000/mm³ - Serum total bilirubin =1.5 x upper limit of normal (ULN) - Transaminases = 2.5 x ULN [ = 5 times ULN only in case of liver metastasis] - Alkaline phosphatase = 5 x ULN - Calculated creatinine clearance (CrCL) (Cockroft-Gault): • = 20 mL/min for age 60 mL/min for age = 80 years 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 77 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 77
Exclusion criteria
Exclusion criteria: 1) Patients aged Grade 1 related to this treatment. 12) Major surgery or trauma within 28 days before registration or presence of any major non-healing wound, fracture or ulcer. 13) Prior participation in an interventional clinical study investigating drugs within 30 days before registration, during the treatment period. 14) Current treatment with any potent CYP3A4-inhibitor or -inducer 15) Pregnant or lactating women or women with positive pregnancy test at screening. 16) Any serious and/or unstable pre-existing medical, psychiatric, psychological, familial, sociological, geographical or other condition that could interfere with the patient’s safety, provision of informed consent, or compliance with the study protocol. 17) Prisoners or persons who are compulsory detained (involuntary incarcerated).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Progression-free survival rate (PFS-R) at 3 months after registration;Secondary Objective: - Overall response rate(ORR); duration of response; duration of stable disease - Response upgrade rate;disease control rate (DCR); duration of disease control - Progression free survival time (PFS); Time to treatment failure (TTF) - Overall survival time (OS) - Quality of life (EORTC QLQ-C30 questionnaire) - Safety and tolerability;Primary end point(s): The primary endpoint is to determine the Progression-free survival rate (PFS-R) at 3 months after registration;Timepoint(s) of evaluation of this end point: 3 months after registration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): · Overall response rate(ORR); duration of response; duration of stable disease · Response upgrade rate;disease control rate (DCR); duration of disease control · Progression free survival time (PFS); Time to treatment failure (TTF) · Overall survival time (OS) · Quality of life (EORTC QLQ-C30 questionnaire) · Safety and tolerability;Timepoint(s) of evaluation of this end point: - | — |
Countries
Austria, Germany, Italy
Contacts
Public ContactRIGGI
Pierre Fabre Medicament
Outcome results
None listed