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 is currently recruiting participants.
Verified March 2014 by Merrimack Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01774851
First received: January 10, 2013
Last updated: March 4, 2014
Last verified: March 2014

January 10, 2013
March 4, 2014
January 2013
July 2015   (final data collection date for primary outcome measure)
Progression Free Survival (PFS) [ Time Frame: 30 months ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Recruiting
120
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
Both
18 Years and older
No
Contact: Sasha Frye 617-441-7667 sfrye@merrimackpharma.com
United States
 
NCT01774851
MM-111-13-02-04
Yes
Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
Not Provided
Study Director: Akos Czibere, MD, PhD Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
March 2014

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