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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary efficacy parameter was the response rate based on RECIST criteria after 3 cycles
Aline Guillot, MD
Institut de Cancérologie de la Loire, Dpt Oncologie Médicale, Saint-Priest en Jarez, France
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)