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

Stomach Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01774851
• Other study ID #: MM-111-13-02-04
• Status: Terminated
• Phase: Phase 2
• First received: January 10, 2013
• Last updated: June 19, 2017
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: June 2017
• Source: Merrimack Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Esophagus Cancer
• Gastroesophageal Junction Cancer
• HER-2 Gene Amplification
• Stomach Cancer
• Stomach Neoplasms

Intervention

Drug:
• MM-111
MM-111 (IV)
• Paclitaxel
Paclitaxel (IV)
• Trastuzumab
Trastuzumab (IV)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merrimack Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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