A Study of MM-121 With Paclitaxel in Platinum Resistant/ Refractory Advanced Ovarian Cancers

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01447706
First received: October 3, 2011
Last updated: June 18, 2013
Last verified: June 2013
  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
Glendale, Arizona, United States, 85306
Pinnacle Oncology
Scottsdale, Arizona, United States, 85258
United States, California
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
Wilshire Oncology Medical Group
Corona, California, United States, 92879
North County Oncology
Oceanside, California, United States, 92056
Central Coast Medical Oncology
Santa Maria, California, United States, 93454
United States, Indiana
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, North Carolina
Carolinas Medical Center/Blumenthal Cancer Center
Charlotte, North Carolina, United States, 28203
United States, Ohio
ProMedica Health System, Inc.
Toledo, Ohio, United States, 43606
United States, Tennessee
Chattanooga GYN Oncology
Chattanooga, Tennessee, United States, 37403
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: June 18, 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 April 17, 2014