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

This study is currently recruiting participants.
Verified March 2013 by Merrimack Pharmaceuticals
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01451632
First received: October 7, 2011
Last updated: March 28, 2013
Last verified: March 2013
History of Changes
  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: 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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 45
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01451632

Locations
United States, California
Recruiting
San Francisco, California, United States, 94115
Contact: Paula Fiermonte     415-885-7605     fiermontep@cc.ucsf.edu    
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02115
Contact: James Cleary, MD, PhD     617-632-6261     jcleary@partners.org    
United States, North Carolina
Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Julie White, RN, OCN     919-843-7115     julie_white@med.unc.edu    
United States, Utah
Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Scott Ellis     801-587-7604     Scott.ellis@hci.utah.edudu    
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: NCT01451632     History of Changes
Other Study ID Numbers: MM-121-05-01-05 (TCD11696)
Study First Received: October 7, 2011
Last Updated: March 28, 2013
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
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Head and Neck Neoplasms
Lung Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Cetuximab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 19, 2013