A Randomized, Open Label Study Comparing the Combination of YONDELIS® and DOXIL®/CAELYX® with DOXIL®/CAELYX® Monotherapy for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
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- STATUS
- Recruiting
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- sponsor
- Janssen R&D LLC
Summary
A Randomized, Open Label Study Comparing the Combination of YONDELIS® and DOXIL®/CAELYX® with DOXIL®/CAELYX® Monotherapy for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Description
This is an open label study, active-controlled, multi-center study. The total duration of the study will be approximately 64 months. The screening phase may last up to 30 days. If the results of the procedures done during the screening period allow study participation, there will be randomization into 1 of 2 study groups. Group A will receive 20 mg dexamethasone to help prevent side effects of the combined chemotherapy, DOXIL®/CAELYX® which is the standard of care chemotherapy regimen to treat advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer, and trabectedin. Participants in Group B will only receive DOXIL®/CAELYX®. Treatment will be given in cycles in either 21 or 28 days depending on the group. In Group A, each cycle is 21 days and the participant will need to come to the study clinic on Days 1, 8, and 15. Study drug will be given on Day 1 of each cycle. In Group B, each cycle is 28 days and participants will need to come to the study clinic on Days 1, 8, 15, and 22. Study drug will be given on Day 1 of each cycle.
Details
| Condition | Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer |
|---|---|
| Clinical Study Identifier | TX145692 |
| Sponsor | Janssen R&D LLC |
| Last Modified on | 8 November 2020 |
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