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A Phase 1 Study of MM-121 in Combination With Cetuximab and Irinotecan in Patients With Advanced Cancers


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer, Squamous Cell Head and Neck Cancer, Non-small Cell Lung Cancer, Triple Negative Breast Cancer, Other Tumors With EGFR Dependence

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Trial Information

A Phase 1 Study of MM-121 in Combination With Cetuximab and Irinotecan in Patients With Advanced Cancers


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of dose limiting toxicity (DLT) events with MM-121 plus cetuximab and the MM-121 plus cetuximab plus irinotecan combination

Outcome Time Frame:

16 months

Safety Issue:

Yes

Principal Investigator

Victor Moyo, MD

Investigator Role:

Study Director

Investigator Affiliation:

Merrimack Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

MM-121-05-01-05 (TCD11696)

NCT ID:

NCT01451632

Start Date:

October 2011

Completion Date:

October 2013

Related Keywords:

  • Colorectal Cancer
  • Squamous Cell Head and Neck Cancer
  • Non-Small Cell Lung Cancer
  • Triple Negative Breast Cancer
  • Other Tumors With EGFR Dependence
  • 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
  • Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Colorectal Neoplasms
  • Head and Neck Neoplasms
  • Lung Neoplasms

Name

Location
Fountain Valley, California  92708
Boston, Massachusetts  
Charlotte, North Carolina  
Salt Lake City, Utah  84112