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Trial record 1 of 1 for:    NCT01774851
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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:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01774851
First received: January 10, 2013
Last updated: June 19, 2017
Last verified: June 2017
January 10, 2013
June 19, 2017
January 2013
July 2015   (Final data collection date for primary outcome measure)
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.
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. ]
Complete list of historical versions of study NCT01774851 on ClinicalTrials.gov Archive Site
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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
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
To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more effective than paclitaxel and trastuzumab alone
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • HER-2 Gene Amplification
  • Esophagus Cancer
  • Gastroesophageal Junction Cancer
  • Stomach Cancer
  • Drug: MM-111
    MM-111 (IV)
  • Drug: Paclitaxel
    Paclitaxel (IV)
  • Drug: Trastuzumab
    Trastuzumab (IV)
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
84
December 2015
July 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01774851
MM-111-13-02-04
Yes
Not Provided
Not Provided
Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
Not Provided
Study Director: Akos Czibere, MD, PhD Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
June 2017

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