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

Phase 2TerminatedNCT01774851

Merrimack Pharmaceuticals84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

MM-111DRUG

MM-111 (IV)

PaclitaxelDRUG

Paclitaxel (IV)

TrastuzumabDRUG

Trastuzumab (IV)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (21)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Los Angeles, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 30 months

Data from ClinicalTrials.gov

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