NCT00422786

Phase II Study of CAP-232 in Patients With Refractory Metastatic Renal Cell Carcinoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Thallion Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the safety and efficacy of CAP-232 in the treatment of patients with previously treated (refractory) renal cell carcinoma

Detailed description

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.

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
DRUG	CAP-232	Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2007-01-17
• Last updated: 2008-07-15

Locations

2 sites across 1 country: France