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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

Primary Purpose

HER-2 Gene Amplification, Esophagus Cancer, Gastroesophageal Junction Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MM-111
Paclitaxel
Trastuzumab
Sponsored by
Merrimack Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HER-2 Gene Amplification focused on measuring HER-2 Gene Amplification, Esophagus Cancer, Gastroesophageal Junction Cancer, Stomach Cancer, Her2 Positive, Her2+, Esophageal Cancer, Metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1a

Arm 1b

Arm Description

MM-111 + Paclitaxel + Trastuzumab

Paclitaxel + Trastuzumab

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 10, 2013
Last Updated
June 19, 2017
Sponsor
Merrimack Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01774851
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
DSMB recommendation due to lack of efficacy. There were no safety signals.
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merrimack Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER-2 Gene Amplification, Esophagus Cancer, Gastroesophageal Junction Cancer, Stomach Cancer
Keywords
HER-2 Gene Amplification, Esophagus Cancer, Gastroesophageal Junction Cancer, Stomach Cancer, Her2 Positive, Her2+, Esophageal Cancer, Metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1a
Arm Type
Experimental
Arm Description
MM-111 + Paclitaxel + Trastuzumab
Arm Title
Arm 1b
Arm Type
Active Comparator
Arm Description
Paclitaxel + Trastuzumab
Intervention Type
Drug
Intervention Name(s)
MM-111
Intervention Description
MM-111 (IV)
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel (IV)
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Intervention Description
Trastuzumab (IV)
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akos Czibere, MD, PhD
Organizational Affiliation
Merrimack Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study of MM-111 and Paclitaxel With Trastuzumab in Patients HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach

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