TLK286 in Combination With Doxil in Platinum Refractory or Resistant Ovarian Cancer

Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Doxil in Platinum Refractory or Resistant Ovarian Cancer

This is a dose-ranging, open-label, Phase 1-2a study of TLK286 in combination with Doxil in patients with platinum refractory or resistant ovarian cancer.

Inclusion Criteria

• Histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube cancer or primary peritoneal cancer
• Recurrent epithelial ovarian cancer or persistent disease following primary treatment
• At least one, but no more than four, prior platinum-containing chemotherapy regimens
• At least one prior taxane-containing regimen

Exclusion Criteria

• A history of prior malignancy except for adequately treated carcinoma in situ of the uterine cervix, basal cell or squamous cell skin cancer, or other cancer for which the patient has been disease-free for 2 years
• Known leptomeningeal metastases or carcinomatous meningitis
• Have received prior Doxil or other liposomal doxorubicin
• Having received whole pelvis radiation therapy