Clinical Trial VICCGYN1206
Title
A phase II randomized open label study of MM-121 in combination with paclitaxel versus paclitaxel alone in patients with platinum resistant/refractory advanced ovarian cancers
Principal Investigator(s)
Details
- Protocol No. VICCGYN1206
- Open Date: 09/25/2012
- Staging: Phase II
- Age Group: Adults
- Scope: International
- Objective: To determine whether the combination of MM-121 plus paclitaxel is more effective than paclitaxel alone based on Progression Free Survival (PFS) in advanced ovarian cancers resistant or refractory to platinum agents.
- Disease Sites: Gynecologic; Ovarian
- Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: MM-121 (SAR256212); Paclitaxel
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01447706
- Secondary Protocol No: MM-121-04-02-08
Description
Participants are being asked to take part in this study because they have a type of advanced gynecological cancer (women-s cancer, which includes ovarian cancer, fallopian tube cancer, and primary peritoneal). Participants are being considered for this study because research has shown that many gynecological cancers have an excess of a certain growth factor receptor (ErbB3) on their surfaces. The purpose of this study is to see if women with gynecological cancer will respond to the combination of a new drug not approved by the Food and Drug Administration, MM-121, plus a drug that is already in use for the treatment of gynecological cancers, paclitaxel.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
|---|---|
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion 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
Exclusion Criteria:
• Evidence of any other active malignancy
• History of severe allergic reactions to paclitaxel or other drugs formulated in Cremophor®EL
Learn More
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