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A Study of MM-111 and Paclitaxel With Trastuzumab in Patients HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach

This study has been terminated.
(DSMB recommendation due to lack of efficacy. There were no safety signals.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01774851
First Posted: January 24, 2013
Last Update Posted: June 22, 2017
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.
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
Results First Submitted: May 10, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: HER-2 Gene Amplification
Esophagus Cancer
Gastroesophageal Junction Cancer
Stomach Cancer
Interventions: Drug: MM-111
Drug: Paclitaxel
Drug: Trastuzumab

  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
Control Group Paclitaxel + Trastuzumab
Experimental Group MM-111 + trastuzumab + paclitaxel

Participant Flow:   Overall Study
    Control Group   Experimental Group
STARTED   42   42 
COMPLETED   42   42 
NOT COMPLETED   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
Control Group Trastuzumab + paclitaxel
Experimental Group MM-111 + trastuzumab + paclitaxel
Total Total of all reporting groups

Baseline Measures
   Control Group   Experimental Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   42   84 
Age 
[Units: Years]
Median (Full Range)
 62.5 
 (35 to 81) 
 63.5 
 (31 to 78) 
 63 
 (31 to 81) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2   4.8%      5  11.9%      7   8.3% 
Male      40  95.2%      37  88.1%      77  91.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      1   2.4%      1   2.4%      2   2.4% 
Not Hispanic or Latino      41  97.6%      41  97.6%      82  97.6% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      12  28.6%      11  26.2%      23  27.4% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      2   4.8%      2   2.4% 
White      30  71.4%      29  69.0%      59  70.2% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   13   13   26 
Denmark   0   1   1 
France   1   0   1 
Korea, Republic of   11   10   21 
Spain   9   8   17 
Taiwan   2   2   4 
United Kingdom   6   8   14 
Subject of child bearing potential 
[Units: Participants]
Count of Participants
 0   2   2 
Height 
[Units: Cm]
Median (Full Range)
 172 
 (154.2 to 190.5) 
 170.19 
 (152.4 to 193.0) 
 171 
 (152.4 to 193) 
Weight 
[Units: Kg]
Median (Full Range)
 73.97 
 (47.1 to 126.6) 
 68 
 (41.2 to 98.2) 
 72.51 
 (41.2 to 126.6) 


  Outcome Measures

1.  Primary:   Progression Free Survival (PFS)   [ Time Frame: 30 months ]


  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
Following the recommendation of the data monitoring committee, this study was terminated prior to enrollment being completed due to lack of efficacy.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: MM-111 Medical Director
Organization: Merrimack Pharmaceuticals
phone: 617-441-1000



Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01774851     History of Changes
Other Study ID Numbers: MM-111-13-02-04
First Submitted: January 10, 2013
First Posted: January 24, 2013
Results First Submitted: May 10, 2017
Results First Posted: June 22, 2017
Last Update Posted: June 22, 2017