Phase II Study of CAP-232 in Patients With Refractory Metastatic Renal Cell Carcinoma
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multi-Centre, Open Label, Phase II Study of the Safety, Efficacy and Pharmacokinetic (PK) Profile of CAP-232 Administered Through Continuous Intravenous Infusion in Patients With Metastatic Kidney Cancer|
- The primary efficacy parameter was the response rate based on RECIST criteria after 3 cycles
- Safety (through clinical and biological evaluations)
- Other efficacy parameters (progression-free survival rate, time to progression and overall survival)
- Pharmacokinetic (PK) characteristics of the first 15 recruited patients
- Quality of life
- Biological modulation (through potential blood and/or urine biomarkers including M2PK)
|Study Start Date:||March 2007|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period.
Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period
Other Name: TLN-232
This was a multi-center, open label, single arm study. Approximately 40 patients were initially planned to be recruited.
Each patient was to receive a treatment cycle consisting of CAP-232 via continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period. Treatment cycles to be repeated in the absence of disease progression or unacceptable toxicity.
Quality of Life questionnaires were to be administered at baseline, after each visit and at the end of the study.
Signs and symptoms of adverse events were closely monitored during treatment cycles. Safety laboratory measures were done at Screening, during the 72hr hospitalization (first cycle), at every interim visit , and at the end of the study. A follow-up safety visit was to be scheduled at least 30 days after the end of treatment.
CAP-232 plasma levels were also determined.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422786
|CRLC Val d'Aurelle Paul-Lamarque|
|Montpellier, France, 34298|
|Institut de Cancérologie de la Loire|
|St-Priest en Jarez, France, 42270|
|Principal Investigator:||Aline Guillot, MD||Institut de Cancérologie de la Loire, Dpt Oncologie Médicale, Saint-Priest en Jarez, France|
|Principal Investigator:||Damien Pouessel, MD||CRLC Val d'Aurelle Paul-Lamarque, Montpellier, France|