Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Long-term Safety of Irinotecan and Carboplatin in Pediatric Refractory Solid Tumors
NCT00990912Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2004
- Primary completion
- Nov 2005
- Sponsor
- Bristol Myers Squibb
- Modality
- Nanoparticles, Monoclonal Antibodies, Small Molecules
- Conditions
- solid tumor
01
Overview
Phase 2, open-label trial of irinotecan hydrochloride liposome injection (II) + temozolomide + bevacizumab in solid tumor (3 arms), sponsored by Bristol Myers Squibb. Primary endpoint: Assessment of safety and tolerability at 22 months. Started Jan 2004; status: completed.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
Carboplatin (+ Irinotecan)
Carboplatin IV every 21 days (likely with Irinotecan)
Irinotecan (12 mg/m2)
Irinotecan IV daily x 10 days every 21 days
Irinotecan (10 mg/m2)
Irinotecan IV daily x 10 days every 21 days
03
Who it enrols
Patients 1-21 years old with refractory solid tumors who completed at least 6 cycles of therapy on BMS protocols CA124-001 or CA124-002 and continue to derive clinical benefit.
04
Endpoints
Primary
Assessment of safety and tolerability
Secondary
Assessment of duration of clinical benefit
Beyond the preview
Go deeper on NCT00990912.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00990912.