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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

Description

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

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

Sites

  • California

    • 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
  • Arizona

    • Pinnacle Oncology, Scottsdale, Arizona, 85258
  • Tennessee

    • Chattanooga GYN Oncology, Chattanooga, Tennessee, 37403
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