A Safety Study of MM-121 With Cetuximab and Irinotecan in Patients With Advanced Cancers

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01451632
First received: October 7, 2011
Last updated: April 28, 2016
Last verified: April 2016
  Purpose
The purpose of this study is to evaluate the safety and tolerability of escalating doses of the MM-121 plus cetuximab and the MM-121 plus cetuximab plus irinotecan combination.

Condition Intervention Phase
Colorectal Cancer
Squamous Cell Head and Neck Cancer
Non-small Cell Lung Cancer
Triple Negative Breast Cancer
Other Tumors With EGFR Dependence
Drug: MM-121 (SAR256212)
Drug: Irinotecan
Drug: Cetuximab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of MM-121 in Combination With Cetuximab and Irinotecan in Patients With Advanced Cancers

Resource links provided by NLM:


Further study details as provided by Merrimack Pharmaceuticals:

Primary Outcome Measures:
  • Number of dose limiting toxicity (DLT) events with MM-121 plus cetuximab and the MM-121 plus cetuximab plus irinotecan combination [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: October 2011
Study Completion Date: June 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1: MM-121 + cetuximab
increasing doses of weekly MM-121 + weekly cetuximab
Drug: MM-121 (SAR256212)
MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)
Drug: Cetuximab
MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)
Experimental: Part 2: MM-121 + cetuximab + irinotecan
increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1
Drug: MM-121 (SAR256212)
MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)
Drug: Irinotecan
MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)
Drug: Cetuximab
MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)

Detailed Description:
This study is a Phase 1 and pharmacologic dose-escalation trial of MM-121 plus cetuximab plus irinotecan. The study will assess the safety, tolerability, and pharmacokinetics of MM-121, cetuximab and irinotecan.
  Eligibility

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

Inclusion Criteria:

  • No standard options remaining
  • Adequate liver and kidney functions
  • 18 years of age or above

Exclusion Criteria:

  • History of any secondary active cancer in the last 3 years.
  • Pregnant or breast feeding
  • History of severe allergic reactions or contraindications to cetuximab or irinotecan
  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: NCT01451632

Locations
United States, California
San Francisco, California, United States, 94115
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Merrimack Pharmaceuticals
Sanofi
Investigators
Study Director: Victor Moyo, MD Merrimack Pharmaceuticals
  More Information

Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01451632     History of Changes
Other Study ID Numbers: MM-121-05-01-05 (TCD11696) 
Study First Received: October 7, 2011
Last Updated: April 28, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Merrimack Pharmaceuticals:
Metastatic Colorectal cancer
Kras wild-type
Squamous cell head and neck cancer
Non-small cell lung cancer
Triple negative breast cancer
EGFR
ErbB3
MM-121
Cetuximab
Irinotecan

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Head and Neck Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Camptothecin
Cetuximab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors

ClinicalTrials.gov processed this record on July 28, 2016