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
18 Years
N/A
Female
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival
Outcome Time Frame:
38 months
Safety Issue:
No
Principal Investigator
Victor Moyo, MD
Investigator Role:
Study Director
Investigator Affiliation:
Merrimack Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
MM-121-04-02-08 (ARD11586)
NCT ID:
NCT01447706
Start Date:
October 2011
Completion Date:
April 2015
Related Keywords:
- Epithelial Ovarian Cancer
- Fallopian Tube Cancer
- Peritoneal Cancer
- Ovarian Cancer
- Platinum-resistant
- Platinum-refractory
- Fallopian tube cancer
- Peritoneal Cancer
- Paclitaxel
- ErbB3
- Phase II
- locally advanced/metastatic or recurrent
- Ovarian Neoplasms
- Peritoneal Neoplasms
- Fallopian Tube Neoplasms
- Neoplasms, Glandular and Epithelial
Name | Location |
|---|---|
| Comprehensive Blood and Cancer Center | Bakersfield, California 93309 |
| Wilshire Oncology Medical Group | Glendora, California 91741 |
| Chattanooga GYN Oncology | Chattanooga, Tennessee 37403 |
| Carolinas Medical Center/Blumenthal Cancer Center | Charlotte, North Carolina 28203 |
| North County Oncology | Oceanside, California 92056 |
| Central Coast Medical Oncology | Santa Maria, California 93454 |
| Indiana University Simon Cancer Center | Indianapolis, Indiana 46202 |
| Pinnacle Oncology | Scottsdale, Arizona 85258 |
| Arizona Center for Cancer Care | Glendale, Arizona 85306 |
| ProMedica Health System, Inc. | Toledo, Ohio 43606 |
