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Trial record 1 of 1 for:    NCT01447225
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Safety Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01447225
First received: October 3, 2011
Last updated: September 13, 2016
Last verified: September 2016
Results First Received: July 12, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Solid Tumors
Interventions: Drug: MM-121
Drug: Carboplatin
Drug: Pemetrexed
Drug: Cabazitaxel
Drug: Gemcitabine

  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
MM-121 Plus Gemcitabine: Cohort 1

MM-121 20 mg/kg one-time loading dose on Cycle 1, Week 1 followed 12 mg/kg IV maintenance doses weekly for 3-week cycles

gemcitabine 1000 mg/m2 IV on Days 1 and 8 of each 3-week cycle

MM-121 Plus Gemcitabine: Cohort 2

MM-121 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle

Gemcitabine: 1000 mg/m2 IV on Day 1 And Day 8 of each 3-week cycle

MM-121 Plus Carboplatin: Cohort 1

MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle

Carboplatin at AUC 6 Day 1 of every 3 week cycle

MM-121 Plus Carboplatin: Cohort 2

MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle

Carboplatin at AUC 5 Day 1 of every 3 week cycle

MM-121 Plus Carboplatin: Cohort 3

MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle

Carboplatin at AUC 5 Day 1 of every 3 week cycle

MM-121 Plus Pemetrexed: Cohort 1

MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle

Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle

MM-121 Plus Pemetrexed: Cohort 2

MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle

Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle

MM-121 Plus Cabazitaxel: Cohort 1

MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle

Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle

MM-121 Plus Cabazitaxel: Cohort 2

MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle

Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle

MM-121 Plus Cabazitaxel: Cohort 3

MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle

Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle


Participant Flow:   Overall Study
    MM-121 Plus Gemcitabine: Cohort 1   MM-121 Plus Gemcitabine: Cohort 2   MM-121 Plus Carboplatin: Cohort 1   MM-121 Plus Carboplatin: Cohort 2   MM-121 Plus Carboplatin: Cohort 3   MM-121 Plus Pemetrexed: Cohort 1   MM-121 Plus Pemetrexed: Cohort 2   MM-121 Plus Cabazitaxel: Cohort 1   MM-121 Plus Cabazitaxel: Cohort 2   MM-121 Plus Cabazitaxel: Cohort 3
STARTED   3   8   5   3   3   3   7   4   3   4 
COMPLETED   3   8   5   3   3   3   7   4   3   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
MM-121 Plus Gemcitabine

escalating doses of MM-121 and gemcitabine on Day 1 and Day 8 of every 3 week cycle

MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV

MM-121 Plus Carboplatin

carboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle

MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV

Carboplatin: administered at AUC 6

MM-121 Plus Pemetrexed

pemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle

MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV

Pemetrexed: administered IV at 500 mg/m2

MM-121 Plus Cabazitaxel

escalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle

MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV

Cabazitaxel: administered IV at 20 mg/m2 or 25 mg/m2

Total Total of all reporting groups

Baseline Measures
   MM-121 Plus Gemcitabine   MM-121 Plus Carboplatin   MM-121 Plus Pemetrexed   MM-121 Plus Cabazitaxel   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   11   10   11   43 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.3  (7.79)   62.7  (9.18)   60.0  (12.29)   64.1  (6.66)   61.28  (8.98) 
Gender 
[Units: Participants]
         
Female   8   5   7   2   22 
Male   3   6   3   9   21 
Ethnicity (NIH/OMB) 
[Units: Participants]
         
Hispanic or Latino   1   0   0   0   1 
Not Hispanic or Latino   10   11   10   11   42 
Unknown or Not Reported   0   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
         
American Indian or Alaska Native   1   0   0   0   1 
Asian   0   0   1   0   1 
Native Hawaiian or Other Pacific Islander   0   0   0   0   0 
Black or African American   0   0   0   0   0 
White   10   11   9   11   41 
More than one race   0   0   0   0   0 
Unknown or Not Reported   0   0   0   0   0 
Region of Enrollment 
[Units: Participants]
         
United States   8   11   7   8   34 
France   3   0   3   3   9 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Anticancer Therapies   [ Time Frame: From date of first dose to 30 days after termination, the longest 88.1 weeks ]

2.  Primary:   To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: MM-121 Doses   [ Time Frame: From date of first dose to 30 days after termination, the longest 88.1 weeks ]

3.  Primary:   To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Gemcitabine   [ Time Frame: From date of first dose to 30 days after termination, the longest 88.1 weeks ]

4.  Primary:   To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Carboplatin   [ Time Frame: From date of first dose to 30 days after termination, the longest 88.1 weeks ]

5.  Primary:   To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Pemetrexed   [ Time Frame: From date of first dose to 30 days after termination, the longest 88.1 weeks ]

6.  Primary:   To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Cabazitaxel   [ Time Frame: From date of first dose to 30 days after termination, the longest 88.1 weeks ]

7.  Primary:   To Characterize Dose-limiting Toxicities (DLTs) Associated With the Combination of MM-121 With Anticancer Therapies   [ Time Frame: From date of first dose to 30 days after termination, the longest 88.1 weeks ]

8.  Secondary:   Objective Response Rate   [ Time Frame: patients were assessed for response during their time on study, the longest of which was 88.1 weeks ]

9.  Secondary:   Pharmacokinetics   [ Time Frame: Collections taken at Cycle 1, Week 1 for all patients at start of the infusion (pretreatment), at the end of the infusion, and at 2, 4, 24 and 48 hours after the start of the MM-121 infusion ]

10.  Secondary:   Pharmacokinetics (AUClast)   [ Time Frame: Collections taken at Cycle 1, Week 1 for all patients at the start of the infusion (pretreatment), at the end of the infusion, and at 2, 4, 24 and 48 hours after the start of the MM-121 infusion ]

11.  Secondary:   Immunogenicity   [ Time Frame: Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 88.1 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: NCT01447225     History of Changes
Other Study ID Numbers: MM-121-06-01-06 (TCD11694)
Study First Received: October 3, 2011
Results First Received: July 12, 2016
Last Updated: September 13, 2016
Health Authority: United States: Food and Drug Administration