Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Phase I Safety Study of the Drug MM-121 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00734305
First received: August 12, 2008
Last updated: August 30, 2016
Last verified: August 2016
Results First Received: July 12, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Advanced Solid Tumors
Intervention: Drug: MM-121

  Participant Flow
  Hide Participant Flow

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
Dose Escalation: Cohort 1 MM-121: 3.2 mg/kg IV QW
Dose Escalation: Cohort 2 MM-121: 6 mg/kg IV QW
Dose Escalation: Cohort 3 MM-121: 10 mg/kg IV QW
Dose Escalation: Cohort 4 MM-121: 15 mg/kg IV QW
Dose Escalation: Cohort 5 MM-121: 20 mg/kg IV QW
Dose Escalation: Cohort 6 MM-121: 40 mg/kg IV loading dose on C1W1 followed by weekly maintenance doses of 20 mg/kg IV QW
Expansion Cohort (Highest tested dose in absence of reaching maximum tolerated dose) 40 mg/kg IV loading dose on C1W1 followed by weekly maintenance doses of 20 mg/kg IV QW

Participant Flow:   Overall Study
    Dose Escalation: Cohort 1     Dose Escalation: Cohort 2     Dose Escalation: Cohort 3     Dose Escalation: Cohort 4     Dose Escalation: Cohort 5     Dose Escalation: Cohort 6     Expansion Cohort  
STARTED     7     3     4     3     5     4     18  
COMPLETED     6 [1]   3     4     3     5     4     18  
NOT COMPLETED     1     0     0     0     0     0     0  
[1] 1 patient was enrolled but did not meet eligibility criteria at C1W1, and thus was never dosed



  Baseline Characteristics
  Hide Baseline Characteristics

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
MM-121 Dose Escalation MM-121: Dose escalation Frequency - once weekly IV
MM-121 Expansion Cohort Expansion cohort at recommended phase 2 dose
Total Total of all reporting groups

Baseline Measures
    MM-121 Dose Escalation     MM-121 Expansion Cohort     Total  
Number of Participants  
[units: participants]
  25     18     43  
Age  
[units: years]
Mean (Standard Deviation)
  61.2  (10.82)     58.5  (8.08)     59.85  (9.45)  
Gender  
[units: participants]
     
Female     12     15     27  
Male     13     3     16  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     1     1     2  
Not Hispanic or Latino     24     17     41  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     2     1     3  
White     23     17     40  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     25     18     43  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response Rate and Duration   [ Time Frame: Time from first dose to date of progression, with a median of 7.1 weeks ]

2.  Primary:   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 47 weeks ]

3.  Secondary:   To Describe the Dose-limiting Toxicity of MM-121 as a Monotherapy   [ Time Frame: From date of first dose to 30 days after termination, the longest 47 weeks ]

4.  Secondary:   To Determine the Pharmacokinetic and Immunogenicity Parameters of MM-121   [ Time Frame: At Cycle 1, Week 1 pre-treatment, at the end of the infusion, and 2, 4, 8, 24, 48 and 72 hours after starting the infusion; pre-dose collections on Cycle 1, Week 2 and Cycle 2, Week 1 for all patients ]

5.  Secondary:   To Determine the Pharmacokinetic Parameters of MM-121   [ Time Frame: At Cycle 1, Week 1 pre-treatment, at the end of the infusion, and 2, 4, 8, 24, 48 and 72 hours after starting the infusion; pre-dose collections on Cycle 1, Week 2 and Cycle 2, Week 1 for all patients ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: NCT00734305     History of Changes
Other Study ID Numbers: MM-121-01-100
MM-121
Study First Received: August 12, 2008
Results First Received: July 12, 2016
Last Updated: August 30, 2016
Health Authority: United States: Food and Drug Administration