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Randomized, Open Label, Phase 2 Study of MM-111 and Paclitaxel With or Without Trastuzumab in Patients With 'Traditional' and 'Non-Traditional' HER2 Expressing Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
HER-2 Gene Amplification, Esophagus Cancer, Gastroesophageal Junction Cancer, Stomach Cancer

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Trial Information

Randomized, Open Label, Phase 2 Study of MM-111 and Paclitaxel With or Without Trastuzumab in Patients With 'Traditional' and 'Non-Traditional' HER2 Expressing Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy


This is a randomized, open Label, Phase 2 Study of MM-111 and Paclitaxel with or without
Trastuzumab in Patients with 'Traditional' and 'Non-Traditional' HER2 Expressing Carcinomas
of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front
Line Metastatic or Locally Advanced Therapy. Up to 180 patients will be randomized in a 1:1
ratio between the experimental and comparator arms within each group.


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 as follows

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Time Frame:

The outcome of PFS will be measured montly for an estimate of 22 months after the first 50 patients are enrolled.

Safety Issue:

No

Principal Investigator

Victor Moyo, MD

Investigator Role:

Study Director

Investigator Affiliation:

Merrimack Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

MM-111-13-02-04

NCT ID:

NCT01774851

Start Date:

January 2013

Completion Date:

December 2014

Related Keywords:

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

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111