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Trial of Exemestane +/- MM-121 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive and/or Progesterone Receptor Positive Her2 Negative Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01151046
First received: June 24, 2010
Last updated: April 11, 2016
Last verified: April 2016
  Purpose
To determine whether the combination MM-121 + Exemestane in ER+ and/or PR+ breast cancer patients is more effective than Exemestane alone

Condition Intervention Phase
Her2 Negative Breast Cancer Patients
Drug: MM-121
Drug: Placebo
Drug: Exemestane
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Phase 2 Trial of Exemestane +/- MM-121 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive (ER+) and/or Progesterone Receptor Positive (PR+) Her2 Negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by Merrimack Pharmaceuticals:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Time from first dose to date of progression, the longest time frame of 79.1 weeks ] [ Designated as safety issue: No ]
    To determine whether MM-121 + exemestane was more effective than placebo + exemestane in prolonging progression-free survival. 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, over approximately 2 years ] [ Designated as safety issue: No ]
    To determine whether MM-121 + exemestane is more effective than placebo + exemestane in prolonging overall survival. This was a time-to-event analysis of time from first dose to date of death.


Enrollment: 118
Study Start Date: June 2010
Study Completion Date: September 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MM-121 (SAR256212) + exemestane Drug: MM-121
MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week
Other Name: SAR256212
Drug: Exemestane
Exemestane (25 mg) administered orally once per day
Other Name: Aromasin
Placebo Comparator: Placebo + exemestane Drug: Placebo
Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week and exemestane (25 mg) administered orally once per day
Drug: Exemestane
Exemestane (25 mg) administered orally once per day
Other Name: Aromasin

Detailed Description:
The study is a double-blind, randomized Phase 2 trial of Exemestane +/- MM-121. The trial is designed to demonstrate whether MM-121 + Exemestane is more effective than Exemestane alone in ER+ and/or PR+ and Her2 negative breast cancer patients that have failed first-line anti-estrogen therapy in the locally advanced or metastatic setting and patients that have progressed during (or within 6 months of completing) adjuvant treatment with a non-steroidal aromatase inhibitor (AI)and/or tamoxifen. Patients will be treated until radiologic or clinical progression of their disease is documented. Local radiologist and/or PI assessment is accepted.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Locally advanced or metastatic breast cancer
  • Histologically or cytologically confirmed ER+ and/or PgR+ and Her2 negative breast cancer
  • ≥ 18 years of age

Exclusion Criteria:

  • Received prior treatment with exemestane
  • Extensive visceral disease (rapidly progressive, life-threatening metastases, including symptomatic lymphangitic metastases)
  • Symptomatic CNS disease
  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: NCT01151046

  Hide Study Locations
Locations
United States, Alabama
Achieve Clinical Research
Birmingham, Alabama, United States, 35209
Achieve Clinical Research
Birmingham, Alabama, United States, 35216
United States, Arizona
Arizona Center for Cancer Care
Glendale, Arizona, United States, 85306
United States, California
Pacific Cancer Medical Center
Anaheim, California, United States, 92801
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
Wilshire Oncology Medical Group, Inc.
Corona, California, United States, 92879
Southwest Cancer Center
Escondido, California, United States, 92025
Hematology Oncology Associates, INC.
Oakland, California, United States, 94609
San Jose Medical Center
San Jose, California, United States, 95124
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
United States, Florida
Pasco-Pinellas Oncology
New Port Richey, Florida, United States, 34652
Hematology Oncology Associates of the Treasure Coast
Port St. Lucie, Florida, United States, 34952
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Horizon Oncology Center
Lafayette, Indiana, United States, 47905
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Tennessee
Tennessee Cancer Specialists Oncology Clinical Trials Center for Biomedical Research
Knoxville, Tennessee, United States, 37909
Tennessee Cancer Specialists, Oncology Clincial Trials Center for Biomedical Research
Knoxville, Tennessee, United States, 37909
Canada, Quebec
Hopital Maissoneuve-Rosemont
Montreal, Quebec, Canada, H1T2M4
McGill University Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Canada, H4J 1C5
CHA St. Sacrement
Quebec, Canada, G1S 4L8
Germany
Onkogologisches zentrum Munich
Munich, Germany, 80836
Brustzentrum HS Kliniken Wiesbaden
Wiesbaden, Germany, 65189
Russian Federation
Medico-Diagnostically Center of International Institution of biological systems n.a.S.M.
Berezina, Russian Federation
Railway Clinical Hospital
St. Petersburg, Russian Federation, 125271
Leningrad Regional Oncology Center
St. Petersburg, Russian Federation, 188663
City Clinical Oncology Center
St. Petersburg, Russian Federation, 197022
Spain
Vall d'Hebrón University Hospital
Barcelona, Spain, 8035
Hospital Clinic (Barcelona)
Barcelona, Spain, 8036
Hospital Parc Tauli - Barcelona
Barcelona, Spain, 8208
Servicio de Oncología Médica / Hospital Universitario Gregorio Marañón
Madrid, Spain, 28007
Puerta de Hierro
Madrid, Spain, 28220
Sponsors and Collaborators
Merrimack Pharmaceuticals
Investigators
Study Director: Victor Moyo, MD Merrimack Pharmaceuticals, Inc.
  More Information

Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01151046     History of Changes
Other Study ID Numbers: MM-121-02-02-03 (ARD11588) 
Study First Received: June 24, 2010
Results First Received: February 14, 2016
Last Updated: April 11, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Merrimack Pharmaceuticals:
Breast Cancer
Her2 negative
Estrogen Receptor Positive
Progesterone Receptor Positive
MM-121
Exemestane
Postmenopausal Women

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
Exemestane
Progesterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Progestins

ClinicalTrials.gov processed this record on September 30, 2016