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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01447706
First received: October 3, 2011
Last updated: April 11, 2016
Last verified: April 2016
  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
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: Time from first dose to date of progression, the longest time frame of 3.9 years ] [ Designated as safety issue: No ]
    To determine whether MM-121 + paclitaxel was more effective than paclitaxel alone in prolonging progression-free survival in advanced ovarian cancers resistant or refractory to platinum agents. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), "as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD).


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Time from first dose to date of death, with a median of approximately 13 months ] [ Designated as safety issue: No ]
    To determine whether MM-121 + paclitaxel is more effective than paclitaxel alone in prolonging overall survival. This was a time-to-event analysis of time from first dose to date of death.


Enrollment: 223
Study Start Date: October 2011
Study Completion Date: June 2015
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Paclitaxel
Standard dosing paclitaxel: 80 mg/m2 QW intravenously)
Drug: Paclitaxel
Standard dosing Paclitaxel (IV)
Experimental: MM-121 (SAR256212) + Paclitaxel
administered intravenously at 40 mg/kg loading dose on Cycle 1, Week 1 followed by 20 mg/kg QW for all subsequent doses
Drug: MM-121
MM-121 (SAR256212) (IV)
Other Name: SAR256212
Drug: Paclitaxel
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Results First Received: February 17, 2016
Last Updated: April 11, 2016
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:
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Albumin-Bound Paclitaxel
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators

ClinicalTrials.gov processed this record on May 25, 2016