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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00994123
First received: October 13, 2009
Last updated: July 12, 2016
Last verified: July 2016
Results First Received: February 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Non-Small-Cell Lung
Interventions: Drug: MM-121
Drug: Erlotinib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Phase 1: MM-121 + Erlotinib Escalating doses of MM-121 and erlotinib
Phase 2: MM-121 + Erlotinib

EGFR wild-type, EGFR-TKI naive patients randomized to receive:

MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o.

Phase 2: Erlotinib

EGFR wild-type, EGFR-TKI naive patients randomized to receive:

daily 150 mg erlotinib p.o. alone


Participant Flow:   Overall Study
    Phase 1: MM-121 + Erlotinib     Phase 2: MM-121 + Erlotinib     Phase 2: Erlotinib  
STARTED     33     85     44  
COMPLETED     33     85     44  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Ph 1: Patients with NSCLC Ph 2:Patients whose tumors are wild-type for EGFR and who have not received prior EGFR TKI targeted therapy.

Reporting Groups
  Description
Phase 1: MM-121 + Erlotinib Escalating doses of MM-121 + Erlotinib in patients with NSCLC
Phase 2: MM-121 + Erlotinib

EGFR wild-type, EGFR-TKI naive patients randomized to receive:

MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o.

Phase 2: Erlotinib

EGFR wild-type, EGFR-TKI naive patients randomized to receive:

daily 150 mg erlotinib p.o. alone

Total Total of all reporting groups

Baseline Measures
    Phase 1: MM-121 + Erlotinib     Phase 2: MM-121 + Erlotinib     Phase 2: Erlotinib     Total  
Number of Participants  
[units: participants]
  33     85     44     162  
Age  
[units: years]
Mean (Standard Deviation)
  63.5  (10.12)     62.9  (10.74)     63.9  (10.16)     63.2  (10.53)  
Gender  
[units: participants]
       
Female     17     35     17     69  
Male     16     50     27     93  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     2     3     1     6  
Not Hispanic or Latino     31     82     43     156  
Unknown or Not Reported     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     1     0     1  
Asian     0     7     6     13  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     2     3     2     7  
White     31     74     36     141  
More than one race     0     0     0     0  
Unknown or Not Reported     0     0     0     0  



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Primary:   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 ]

4.  Post-Hoc:   To Explore the Utility of an EGFR Family Receptor-ligand (Heregulin, HRG) as a Predictor of Response to MM-121 and /or Erlotinib in Formalin Fixed (FFPE) Tumor Samples   [ Time Frame: Time from first dose to date of progression, with a median of 8.1 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Clinical Trial Manager
Organization: Merrimack Pharmaceuticals
phone: 617-441-1000
e-mail: smathews@merrimack.com



Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00994123     History of Changes
Other Study ID Numbers: MM-121-01-101
Study First Received: October 13, 2009
Results First Received: February 14, 2016
Last Updated: July 12, 2016
Health Authority: United States: Food and Drug Administration