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A Safety Study of MM-121 With Cetuximab and Irinotecan in Patients With Advanced Cancers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01451632
First Posted: October 13, 2011
Last Update Posted: September 8, 2016
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.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
Results First Submitted: July 12, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Colorectal Cancer
Squamous Cell Head and Neck Cancer
Non-small Cell Lung Cancer
Triple Negative Breast Cancer
Other Tumors With EGFR Dependence
Interventions: Drug: MM-121
Drug: Irinotecan
Drug: Cetuximab

  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
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Reporting Groups
  Description
Part 1: Cohort 1 MM-121: 12 mg/kg IV weekly in 4-week cycles Cetuximab: 400 mg/m2 IV one-time loading dose followed by 200 mg/m2 IV weekly maintenance doses
Part 1: Cohort 2a MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
Part 1: Cohort 2b MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
Part 1: Cohort 3a MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
Part 1: Cohort 3b MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
Part 1: Cohort 4 MM-121: 40 mg/kg one time loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 one-time loading dose followed by 250 mg/m2 maintenance IV QW
Part 1: Expansion Cohort MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
Part 2: Cohort 1

MM-121: 20 mg/kg IV QW

Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW

Irinotecan: 180 mg/m2 IV Q2W

Part 2: Cohort 2

MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW

Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW

Irinotecan: 180 mg/m2 IV Q2W

Part 2: Expansion Cohort

MM-121: 20 mg/kg IV QW

Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW

Irinotecan: 180 mg/m2 IV Q2W


Participant Flow:   Overall Study
    Part 1: Cohort 1   Part 1: Cohort 2a   Part 1: Cohort 2b   Part 1: Cohort 3a   Part 1: Cohort 3b   Part 1: Cohort 4   Part 1: Expansion Cohort   Part 2: Cohort 1   Part 2: Cohort 2   Part 2: Expansion Cohort
STARTED   8   4   3   3   4   4   8   6   4   4 
COMPLETED   8   4   3   3   4   4   8   6   4   4 
NOT COMPLETED   0   0   0   0   0   0   0   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.
No text entered.

Reporting Groups
  Description
Part 1: MM-121 + Cetuximab

increasing doses of weekly MM-121 + weekly cetuximab

MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)

Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)

Part 2: MM-121 + Cetuximab + Irinotecan

increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1

MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)

Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)

Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)

Total Total of all reporting groups

Baseline Measures
   Part 1: MM-121 + Cetuximab   Part 2: MM-121 + Cetuximab + Irinotecan   Total 
Overall Participants Analyzed 
[Units: Participants]
 34   14   48 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.1  (14.19)   56.6  (11.38)   56.35  (12.79) 
Gender 
[Units: Participants]
     
Female   13   9   22 
Male   21   5   26 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   2   1   3 
Not Hispanic or Latino   31   13   44 
Unknown or Not Reported   1   0   1 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   3   0   3 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   3   0   3 
White   26   13   39 
More than one race   0   0   0 
Unknown or Not Reported   2   1   3 
Region of Enrollment 
[Units: Participants]
     
United States   34   14   48 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Cetuximab and the MM-121 Plus Cetuximab Plus Irinotecan Combination   [ Time Frame: From date of first dose to 30 days after termination, the longest 48.1 weeks ]

2.  Primary:   To Further Determine the Safety Parameters of the MM-121 + Cetuximab and MM-121 + Cetuximab + Irinotecan Combination by Determining the Recommended Phase 2 Dose (RP2D) of the Combination(s) (Via Recording of Maximum Tolerated Dose (MTD)): MM-121 Doses   [ Time Frame: From date of first dose to 30 days after termination, the longest 48.1 weeks ]

3.  Primary:   To Further Determine the Safety Parameters of the MM-121 + Cetuximab and MM-121 + Cetuximab + Irinotecan Combination by Determining the Recommended Phase 2 Dose (RP2D) of the Combination(s): Cetuximab and Irinotecan   [ Time Frame: From date of first dose to 30 days after termination, the longest 48.1 weeks ]

4.  Secondary:   Objective Response Rate   [ Time Frame: Patients were assessed for objective response from time of first dose through treatment termination, the longest treatment duration being 48.1 weeks ]

5.  Secondary:   Pharmacokinetics   [ Time Frame: Collections taken for all patients at Cycle 1, Week 1 at pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121 ]

6.  Secondary:   Pharmacokinetic Parameters of MM-121   [ Time Frame: Collections taken for all patients at Cycle 1, Week 1 at pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121 ]

7.  Secondary:   Immunogenicity   [ Time Frame: Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 48.1 weeks, and a collection was made post-infusion in any case of infusion reaction ]


  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, Inc.
phone: 617-441-1000
e-mail: smathews@merrimack.com



Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01451632     History of Changes
Other Study ID Numbers: MM-121-05-01-05 (TCD11696)
First Submitted: October 7, 2011
First Posted: October 13, 2011
Results First Submitted: July 12, 2016
Results First Posted: September 8, 2016
Last Update Posted: September 8, 2016