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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00994123
Recruitment Status : Completed
First Posted : October 14, 2009
Results First Posted : August 22, 2016
Last Update Posted : August 22, 2016
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE October 13, 2009
First Posted Date  ICMJE October 14, 2009
Results First Submitted Date  ICMJE February 14, 2016
Results First Posted Date  ICMJE August 22, 2016
Last Update Posted Date August 22, 2016
Study Start Date  ICMJE February 2010
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2016)
  • 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: From date of first dose to 30 days after termination, the longest 175 weeks ]
    To establish the safety of escalating doses of MM-121 in combination with erlotinib in order to determine the recommended phase 2 dose of the combination for the second part of the study. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.
  • Phase 1: Determine the Maximum Tolerated Dose Dependent on Reports of Dose-limiting Toxicities [ Time Frame: From date of first dose to 30 days after termination, the longest 175 weeks ]
    Using a 3+3 dose escalation model, the maximum tolerated dose was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in the expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was used as the recommended Phase 2 dose.
  • Phase 2: Progression-free Survival of the MM-121 + Erlotinib Combination [ Time Frame: Time from first dose to date of progression, with a median of 8.1 weeks ]
    This was a time-to-event measure using Progression-Free Survival (PFS) comparing MM-121 + erlotinib vs.erlotinib alone. Progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression free survival was defined as the number of weeks from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD).
Original Primary Outcome Measures  ICMJE
 (submitted: October 13, 2009)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2009)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of MM-121 Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer
Official Title  ICMJE A Phase 1-2 Trial of MM-121 in Combination With Erlotinib in Three Groups of Patients With Non-Small Cell Lung Cancer
Brief Summary A Phase 1-2 study of MM-121 in combination with standard therapy for non-small cell lung cancer (NSCLC).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: MM-121
    MM-121 (SAR256212) = intravenous solution
    Other Name: SAR256212
  • Drug: Erlotinib
    erlotinib = daily oral tablet
    Other Name: Tarceva
Study Arms  ICMJE
  • Experimental: Phase 1: Dose-Escalation
    Escalating doses of MM-121 (QOW IV) and erlotinib (daily PO)
    Interventions:
    • Drug: MM-121
    • Drug: Erlotinib
  • Active Comparator: Phase 2: Control
    Erlotinib (daily)
    Intervention: Drug: Erlotinib
  • Experimental: Phase 2: Treatment
    MM-121 (QOW IV) and erlotinib (daily PO)
    Interventions:
    • Drug: MM-121
    • Drug: Erlotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2016)
162
Original Estimated Enrollment  ICMJE
 (submitted: October 13, 2009)
40
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Germany,   Korea, Republic of,   Spain,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00994123
Other Study ID Numbers  ICMJE MM-121-01-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merrimack Pharmaceuticals
Study Sponsor  ICMJE Merrimack Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Victor Moyo, MD Merrimack Pharmaceuticals
PRS Account Merrimack Pharmaceuticals
Verification Date July 2016

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