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: February 3, 2016
Last verified: February 2016

October 7, 2011
February 3, 2016
October 2011
November 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01451632 on ClinicalTrials.gov Archive Site
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A Safety Study of MM-121 With Cetuximab and Irinotecan in Patients With Advanced Cancers
A Phase 1 Study of MM-121 in Combination With Cetuximab and Irinotecan in Patients With Advanced Cancers
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.
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.
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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)
    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)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
June 2014
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01451632
MM-121-05-01-05 (TCD11696)
No
Not Provided
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Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
Sanofi
Study Director: Victor Moyo, MD Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP