A Study of MM-121 With Paclitaxel in Platinum Resistant/ Refractory Advanced Ovarian Cancers
This study is currently recruiting participants.
Verified February 2013 by Merrimack Pharmaceuticals
Sponsor:
Merrimack Pharmaceuticals
Collaborator:
Sanofi
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01447706
First received: October 3, 2011
Last updated: February 27, 2013
Last verified: February 2013
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Purpose
To determine whether the combination of MM-121 plus paclitaxel is more effective than paclitaxel alone
| Condition | Intervention | Phase |
|---|---|---|
|
Epithelial Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer |
Drug: MM-121 (SAR256212) + Paclitaxel Drug: Paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Merrimack Pharmaceuticals:
Primary Outcome Measures:
- Progression Free Survival [ Time Frame: 38 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 210 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Paclitaxel |
Drug: Paclitaxel
Standard dosing Paclitaxel (IV)
|
| Experimental: MM-121 (SAR256212) + Paclitaxel |
Drug: MM-121 (SAR256212) + Paclitaxel
MM-121 (SAR256212) (IV) plus standard dosing Paclitaxel (IV)
|
Detailed 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.
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447706
Locations
| United States, Arizona | |
| Arizona Center for Cancer Care | Recruiting |
| Glendale, Arizona, United States, 85306 | |
| Contact: Victoria Noboa vnoboa@arizonaccc.com | |
| Pinnacle Oncology | Recruiting |
| Scottsdale, Arizona, United States, 85258 | |
| Contact: Patricia Shannon pshannon@azpoh.com | |
| United States, California | |
| Comprehensive Blood and Cancer Center | Recruiting |
| Bakersfield, California, United States, 93309 | |
| Contact: Bobbie Wyatt bwyatt@cbccusa.com | |
| Wilshire Oncology Medical Group | Recruiting |
| Corona, California, United States, 92879 | |
| Contact: Lilia Jaramillo-Palomo Lilia.jaramillo-palomo@womgi.com | |
| North County Oncology | Recruiting |
| Oceanside, California, United States, 92056 | |
| Contact: Marina Marinine NCOMC.Clinical.Research@gmail.com | |
| Central Coast Medical Oncology | Recruiting |
| Santa Maria, California, United States, 93454 | |
| Contact: Nicki Tieken nicki.tieken@gmail.com | |
| United States, Indiana | |
| Indiana University Simon Cancer Center | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Carol Kulesavage ckulesav@iupui.edu | |
| United States, North Carolina | |
| Carolinas Medical Center/Blumenthal Cancer Center | Recruiting |
| Charlotte, North Carolina, United States, 28203 | |
| Contact: Sarah Norek 740-355-1520 sarah.norek@carolinashealthcare.org | |
| United States, Ohio | |
| ProMedica Health System, Inc. | Recruiting |
| Toledo, Ohio, United States, 43606 | |
| Contact: Julie Moon julie.moon@promedica.org | |
| United States, Tennessee | |
| Chattanooga GYN Oncology | Recruiting |
| Chattanooga, Tennessee, United States, 37403 | |
| Contact: Jennifer Wiggs Jennifer@chatgynonc.com | |
Sponsors and Collaborators
Merrimack Pharmaceuticals
Sanofi
Investigators
| Study Director: | Victor Moyo, MD | Merrimack Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Merrimack Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01447706 History of Changes |
| Other Study ID Numbers: | MM-121-04-02-08 (ARD11586) |
| Study First Received: | October 3, 2011 |
| Last Updated: | February 27, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Merrimack Pharmaceuticals:
|
Ovarian Cancer Platinum-resistant Platinum-refractory Fallopian tube cancer Peritoneal Cancer |
Paclitaxel ErbB3 Phase II locally advanced/metastatic or recurrent |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Neoplasms by Histologic Type Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013