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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

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.
 
ClinicalTrials.gov Identifier: NCT01774851
Recruitment Status : Terminated (DSMB recommendation due to lack of efficacy. There were no safety signals.)
First Posted : January 24, 2013
Results First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 10, 2013
First Posted Date  ICMJE January 24, 2013
Results First Submitted Date  ICMJE May 10, 2017
Results First Posted Date  ICMJE June 22, 2017
Last Update Posted Date June 22, 2017
Study Start Date  ICMJE January 2013
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
Progression Free Survival (PFS) [ Time Frame: 30 months ]
Target and non-target lesion antitumor response and disease progression during treatment with each dosing regimen will be evaluated using the international criteria proposed by the RECIST v1.1. Disease status will be assessed every 8 weeks from the date of the first dose of any drug in a regimen.
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2013)
Progression Free Survival (PFS) [ Time Frame: The outcome of PFS will be measured montly for an estimate of 22 months after the first 50 patients are enrolled. ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of MM-111 and Paclitaxel With Trastuzumab in Patients HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach
Official Title  ICMJE Randomized, Open Label, Phase 2 Study of MM-111 and Paclitaxel With Trastuzumab in Patients With HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy
Brief Summary To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more effective than paclitaxel and trastuzumab alone
Detailed Description This is a randomized, open Label, Phase 2 Study of MM-111 and Paclitaxel withTrastuzumab in Patients with HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy. Approximately 120 patients will be randomized in a 1:1 ratio between the experimental and comparator arms.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HER-2 Gene Amplification
  • Esophagus Cancer
  • Gastroesophageal Junction Cancer
  • Stomach Cancer
Intervention  ICMJE
  • Drug: MM-111
    MM-111 (IV)
  • Drug: Paclitaxel
    Paclitaxel (IV)
  • Drug: Trastuzumab
    Trastuzumab (IV)
Study Arms  ICMJE
  • Experimental: Arm 1a
    MM-111 + Paclitaxel + Trastuzumab
    Interventions:
    • Drug: MM-111
    • Drug: Paclitaxel
    • Drug: Trastuzumab
  • Active Comparator: Arm 1b
    Paclitaxel + Trastuzumab
    Interventions:
    • Drug: Paclitaxel
    • Drug: Trastuzumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 19, 2017)
84
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2013)
180
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have documentation of histologically or cytologically confirmed metastatic or locally advanced adenocarcinoma of the distal esophagus, GE junction or stomach
  • Patients must have documentation of histologically or cytologically confirmed HER2 expression
  • Patients must be ≥18 years of age
  • Patients must have ECOG PS of 0, 1, or 2
  • Patients must have adequate hematologic status, renal and hepatic function

Exclusion Criteria:

  • Patients with known hypersensitivity to any of the components of MM-111
  • Patients with a known history of hypersensitivity to paclitaxel or other drugs formulated in Cremophor® EL
  • Patients with a known history of hypersensitivity to trastuzumab or any of its components (group 1 patients only)
  • Patients with an active infection or with an unexplained fever >38.5°C
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01774851
Other Study ID Numbers  ICMJE MM-111-13-02-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merrimack Pharmaceuticals
Study Sponsor  ICMJE Merrimack Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Akos Czibere, MD, PhD Merrimack Pharmaceuticals
PRS Account Merrimack Pharmaceuticals
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP