From Cynthia Chua, M.D., OHC Principal Investigator, Gynecology Oncology Clinical Trials
March 3, 2016
The OHC Department of Clinical Research is offering a clinical trial, GYN41, utilizing Doxil with or without Trabectedin (YONDELIS), a DNA-binding agent that inhibits inducible transcription.
This trial is enrolling advanced relapsed patients with Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube cancer. Currently, there are few prospective studies that have examined the third-line treatment of patients with refractory epithelial ovarian cancer.
- Single-agent activity of Trabectedin has been studied in several Phase 1 and 2 clinical studies. Trabectedin had a favorable safety profile and promising activity in recurrent ovarian cancer patients. The pooled analysis of three Phase 2 studies showed a response rate of 34 percent and time-to-progression of 5.8 months in subjects who had a progression free interval of 6 months or more after the last platinum-based therapy. No efficacy difference was seen between the patients with two prior lines of platinum-based therapy and patients with only one prior platinum-based therapy.
- On the basis of prior clinical experience, the combination of non-platinum agents, Trabectedin and DOXIL, is expected to provide improved efficacy compared with DOXIL monotherapy and an acceptable safety profile in subjects with platinum-sensitive advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who have received two prior lines of platinum-based chemotherapy.
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