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

Merrimack Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Gastroesophageal Junction Cancer; Esophagus Cancer; HER-2 Gene Amplification; Stomach Cancer

Treatments: Drug: Trastuzumab; Drug: MM-111; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01774851

MM-111-13-02-04

Details and patient eligibility

About

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

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Arm 1a

Experimental group

Description:

MM-111 + Paclitaxel + Trastuzumab

Treatment:

Drug: Trastuzumab

Drug: MM-111

Drug: Paclitaxel

Arm 1b

Active Comparator group

Description:

Paclitaxel + Trastuzumab

Treatment:

Drug: Trastuzumab

Drug: Paclitaxel