We're sorry, but this trial is no longer enrolling volunteers.
5GYN-12-2-A Phase II Randomized Open Label Study of MM-121 in combination with Paclitaxel versus Paclitaxel alone in participants with Platinum Resistant/ Refractory Advanced Ovarian Cancers
This is a multicenter, open-label, randomized, Phase II study of MM-121 in patients with
platinum resistant or refractory recurrent/advanced ovarian cancers. Up to 210 patients will
be randomized (2:1) to receive MM-121 plus paclitaxel or paclitaxel alone.
Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.
Inclusion and Exclusion Criteria
- Locally advanced/metastatic or recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
- Received at least one prior platinum based chemotherapy regimen
- Platinum-resistant or refractory
- Eligible for weekly paclitaxel
- Adequate liver and kidney function
- 18 years of age or above
- Evidence of any other active malignancy
- History of severe allergic reactions to paclitaxel or other drugs formulated in Cremophor
- Wilshire Oncology Medical Group, Corona, California, 92879
- North County Oncology, Oceanside, California, 92056
- Comprehensive Blood and Cancer Center, Bakersfield, California, 93309
- Central Coast Medical Oncology, Santa Maria, California, 93454
- Pinnacle Oncology, Scottsdale, Arizona, 85258
- Chattanooga GYN Oncology, Chattanooga, Tennessee, 37403