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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival (PFS)
The outcome of PFS will be measured montly for an estimate of 22 months after the first 50 patients are enrolled.
No
Victor Moyo, MD
Study Director
Merrimack Pharmaceuticals
United States: Food and Drug Administration
MM-111-13-02-04
NCT01774851
January 2013
December 2014
Name | Location |
---|---|
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |