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Trial record 1 of 1 for:    MM-121-01-101
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A Study of MM-121 Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer

This study is currently recruiting participants.
Verified February 2013 by Merrimack Pharmaceuticals
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00994123
First received: October 13, 2009
Last updated: February 21, 2013
Last verified: February 2013
History of Changes

October 13, 2009
February 21, 2013
February 2010
April 2013   (final data collection date for primary outcome measure)
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 ]
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: December 2009 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00994123 on ClinicalTrials.gov Archive Site
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 ]
Phase 2: To estimate the Non-Progression Rate of the MM-121 + erlotinib combination at >/= 24 weeks in patients with NSCLC. [ Time Frame: January 2011 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of MM-121 Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer
A Phase 1-2 Trial of MM-121 in Combination With Erlotinib in Three Groups of Patients With Non-Small Cell Lung Cancer

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

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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
  • Drug: MM-121 (SAR256212) + erlotinib
    MM-121 (SAR256212) = intravenous solution erlotinib = daily oral tablet
    Other Name: MM-121 (SAR256212) + Tarceva
  • Drug: Erlotinib
    erlotinib = daily oral tablet
    Other Name: Tarceva
  • Experimental: MM-121+erlotinib
    Intervention: Drug: MM-121 (SAR256212) + erlotinib
  • Active Comparator: Erlotinib (Tarceva)
    Intervention: Drug: Erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
260
July 2013
April 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Not Provided
United States,   Canada,   Germany,   Korea, Republic of,   Spain,   Taiwan
 
NCT00994123
MM-121-01-101 (ARD11585)
No
Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
Sanofi
Study Director: Victor Moyo, MD Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
February 2013

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