A Study of MM-121 Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00994123
First received: October 13, 2009
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

A Phase 1-2 study of MM-121 in combination with standard therapy for non-small cell lung cancer (NSCLC).


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: MM-121 (SAR256212) + erlotinib
Drug: Erlotinib
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1-2 Trial of MM-121 in Combination With Erlotinib in Three Groups of Patients With Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Merrimack Pharmaceuticals:

Primary Outcome Measures:
  • Phase 1: To determine the recommended Phase 2 dose of the MM-121 + erlotinib combination based upon either the maximum tolerated dose (MTD) or the maximum feasible dose of the combination in patients with NSCLC. [ Time Frame: June 2011 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Phase 2: To estimate the progression-free survival of the MM-121 + erlotinib combination in patients with NSCLC. [ Time Frame: December 2012 ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: February 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MM-121+erlotinib Drug: MM-121 (SAR256212) + erlotinib
MM-121 (SAR256212) = intravenous solution erlotinib = daily oral tablet
Other Name: MM-121 (SAR256212) + Tarceva
Active Comparator: Erlotinib (Tarceva) Drug: Erlotinib
erlotinib = daily oral tablet
Other Name: Tarceva

Detailed Description:

Phase 1: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to evaluate the safety, tolerability and recommended Phase 2 dose of MM-121 in combination with standard therapy.

Phase 2: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to estimate the progression-free survival of the MM-121 + standard therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with locally advanced or metastatic non-small cell lung cancer.
  • Patients must be >/= 18 years of age.
  • Patients must have adequate Performance Status (PS) as measured by ECOG and adequate end organ function.

Exclusion Criteria:

  • Patients with a recent history (within 5 years) of another malignancy.
  • Patients who are pregnant or nursing.
  • Patients with clinically significant heart failure.
  • Patients with clinically significant eye or gastrointestinal abnormalities.
  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: NCT00994123

  Show 38 Study Locations
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: NCT00994123     History of Changes
Other Study ID Numbers: MM-121-01-101 (ARD11585)
Study First Received: October 13, 2009
Last Updated: September 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merrimack Pharmaceuticals:
Non-Small Cell Lung Cancer
NSCLC
Advanced Non-Small Cell Lung Cancer
Metastatic Non-Small Cell Lung Cancer
Lung Cancer
Erlotinib
Tarceva
MM-121
ErbB3
Her3
Epidermal Growth Factor Receptor
anti-ErbB3 human monoclonal antibody
ErbB3 antagonist

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Erlotinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on October 22, 2014