Study Stopped
DSMB recommendation due to lack of efficacy. There were no safety signals.
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
1 other identifier
interventional
84
1 country
21
Brief Summary
To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more effective than paclitaxel and trastuzumab alone
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2013
Typical duration for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 10, 2013
CompletedFirst Posted
Study publicly available on registry
January 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
June 22, 2017
CompletedJune 22, 2017
June 1, 2017
2.5 years
January 10, 2013
May 10, 2017
June 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
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.
30 months
Study Arms (2)
Arm 1a
EXPERIMENTALMM-111 + Paclitaxel + Trastuzumab
Arm 1b
ACTIVE COMPARATORPaclitaxel + Trastuzumab
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
Los Angeles, California, 90089, United States
Unknown Facility
Los Angeles, California, 90095, United States
Unknown Facility
Stanford, California, 94305, United States
Unknown Facility
Denver, Colorado, 80218, United States
Unknown Facility
Ocala, Florida, 34471, United States
Unknown Facility
St. Petersburg, Florida, 33705, United States
Unknown Facility
Urbana, Illinois, 61801, United States
Unknown Facility
Boston, Massachusetts, 02111, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
Rochester, Minnesota, 55905, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Las Vegas, Nevada, 89135, United States
Unknown Facility
Buffalo, New York, 14263, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Cleveland, Ohio, 44106, United States
Unknown Facility
Columbus, Ohio, 43210, United States
Unknown Facility
Philadelphia, Pennsylvania, 19111, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15232, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Unknown Facility
Wenatchee, Washington, 98801, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Following the recommendation of the data monitoring committee, this study was terminated prior to enrollment being completed due to lack of efficacy.
Results Point of Contact
- Title
- MM-111 Medical Director
- Organization
- Merrimack Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Akos Czibere, MD, PhD
Merrimack Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2013
First Posted
January 24, 2013
Study Start
January 1, 2013
Primary Completion
July 1, 2015
Study Completion
December 1, 2015
Last Updated
June 22, 2017
Results First Posted
June 22, 2017
Record last verified: 2017-06