Fallopian Tube Cancer Clinical Trial
Official 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
| Verified date | June 2013 |
| Source | Merrimack Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
To determine whether the combination of MM-121 plus paclitaxel is more effective than paclitaxel alone
| Status | Active, not recruiting |
| Enrollment | 210 |
| Est. completion date | April 2015 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Comprehensive Blood and Cancer Center | Bakersfield | California |
| United States | Carolinas Medical Center/Blumenthal Cancer Center | Charlotte | North Carolina |
| United States | Chattanooga GYN Oncology | Chattanooga | Tennessee |
| United States | Wilshire Oncology Medical Group | Corona | California |
| United States | Arizona Center for Cancer Care | Glendale | Arizona |
| United States | Indiana University Simon Cancer Center | Indianapolis | Indiana |
| United States | North County Oncology | Oceanside | California |
| United States | Central Coast Medical Oncology | Santa Maria | California |
| United States | Pinnacle Oncology | Scottsdale | Arizona |
| United States | ProMedica Health System, Inc. | Toledo | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Merrimack Pharmaceuticals | Sanofi |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression Free Survival | 38 months | No |
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