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. (see Contacts and Locations)
Verified September 2014 by Merrimack Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01774851
First received: January 10, 2013
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more effective than paclitaxel and trastuzumab alone


Condition Intervention Phase
HER-2 Gene Amplification
Esophagus Cancer
Gastroesophageal Junction Cancer
Stomach Cancer
Drug: MM-111
Drug: Paclitaxel
Drug: Trastuzumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merrimack Pharmaceuticals:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: 30 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1a
MM-111 + Paclitaxel + Trastuzumab
Drug: MM-111
MM-111 (IV)
Drug: Paclitaxel
Paclitaxel (IV)
Drug: Trastuzumab
Trastuzumab (IV)
Active Comparator: Arm 1b
Paclitaxel + Trastuzumab
Drug: Paclitaxel
Paclitaxel (IV)
Drug: Trastuzumab
Trastuzumab (IV)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774851

Contacts
Contact: Kerry Horgan 617-441-7478 khorgan@merrimackpharma.com

  Hide Study Locations
Locations
United States, Alabama
Recruiting
Birmingham, Alabama, United States, 35294
Contact: Aparna Tamhane, CCRP    (205) 996-2782    aparna@uab.edu   
United States, California
Recruiting
Los Angeles, California, United States, 90089
Contact: Catherine Ticong, RN    (323) 865-0460    Catherine.Ticong@med.usc.edu   
Recruiting
Los Angeles, California, United States, 90095
Contact: Lisa Yonemoto    310-582-4063    lyonemoto@mednet.ucla.edu   
Recruiting
Stanford, California, United States, 94305
Contact: Flordeliza Mendoza, CCRC    650-724-2056    flormend@stanford.edu   
United States, Colorado
Recruiting
Denver, Colorado, United States, 80218
Contact: Bobbie Donnachaidh    303-430-2706    bobbie.donnachaidh@usoncology.com   
United States, Florida
Recruiting
Ocala, Florida, United States, 34471
Contact: Amy Liebmann    650-724-2056    amy.liebmann@usoncology.com   
Recruiting
St Petersburg, Florida, United States, 33705
Contact: Christine Biermeier       cbiermeier@flcancer.com   
United States, Illinois
Recruiting
Urbana, Illinois, United States, 61801
Contact: Tracy Sharp       tracy.sharp@carle.com   
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02114
Contact: Ashley Flibotte       aflibotte@partners.org   
Recruiting
Boston, Massachusetts, United States, 02111
Contact: Shrikar Rajagopal    617-636-2883      
United States, Minnesota
Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jodi Klocke    507-538-1070    klocke.jodi@mayo.edu   
United States, Missouri
Recruiting
St. Louis, Missouri, United States, 63110
Contact: Kimberly Lears, BS, MA, CCRP    314.747.8085    klears@dom.wustl.edu   
United States, Nevada
Recruiting
Las Vegas, Nevada, United States, 89135
Contact: Rebecca Boucher    702-952-3400 ext 13724    rebecca.boucher@usoncology.com   
United States, New York
Recruiting
Buffalo, New York, United States, 14263
Contact: Cathy Grande, BS, CCRP    716-845-8309    catherine.grande@roswellpark.org   
United States, North Carolina
Recruiting
Durham, North Carolina, United States, 27710
Contact: Ireka Burrus    919-668-1861    ireka.burrus@duke.edu   
United States, Ohio
Recruiting
Cleveland, Ohio, United States, 44106
Contact: Michael K Gibson, MD PhD FACP    216.286.6741    michael.gibson@uhhospitals.org   
Recruiting
Columbus, Ohio, United States, 43210
Contact: Audrey Adkins    614-366-0372    audrey.adkins@osumc.edu   
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Joan Leahy    215-214-1472    joan.bloch@fccc.edu   
Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Gail Tribble    412-647-8205    gtribble@upmc.edu   
United States, Tennessee
Recruiting
Nashville, Tennessee, United States, 37203
Contact: Julie Trundle    615-329-7413    julie.trundle@scresearch.net   
United States, Washington
Recruiting
Wenatchee, Washington, United States, 98801
Contact: LaDonna Muscatell, RN, CCRC    (509) 663-8711 ext 5014    lmuscatell@wvmedical.com   
Withdrawn
Yakima, Washington, United States, 98092
Sponsors and Collaborators
Merrimack Pharmaceuticals
Investigators
Study Director: Akos Czibere, MD, PhD Merrimack Pharmaceuticals
  More Information

No publications provided

Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01774851     History of Changes
Other Study ID Numbers: MM-111-13-02-04
Study First Received: January 10, 2013
Last Updated: September 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merrimack Pharmaceuticals:
HER-2 Gene Amplification
Esophagus Cancer
Gastroesophageal Junction Cancer
Stomach Cancer
Her2 Positive
Her2+
Esophageal Cancer
Metastatic

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014