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CAELYX vs Paclitaxel in Platinum-Refractory Ovarian Carcinoma
NCT00653952Phase 3
Key facts
- Status
- Terminated
- Start
- May 1997
- Sponsor
- Johnson & Johnson
- Modality
- Targeted Liposomes, Stealth (PEGylated) Liposomes, Conventional Liposomes
- Conditions
- ovarian carcinoma
01
Overview
Phase 3, randomised, open-label trial of pegylated liposomal doxorubicin in ovarian carcinoma (2 arms), sponsored by Johnson & Johnson. Primary endpoint: Time to Progression. Started May 1997; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
CAELYX
CAELYX 50 mg/m2 IV every 28 days
Paclitaxel HCl
Paclitaxel HCl 175 mg/m2 IV every 21 days
03
Endpoints
Primary
Time to Progression
Secondary
Response Rates
Time to Response
Duration of Response
Quality of Life Assessment
Survival
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