NCT01209195

A Study of MM-121 in Combination With Paclitaxel in Patients With Advanced Gynecologic and Breast Cancers

A Phase 1, Pharmacologic and Pharmacodynamic Study of MM-121 in Combination With Paclitaxel in Patients With Advanced Gynecologic and Breast Cancers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Merrimack Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was a Phase 1 and pharmacologic open-labeled dose-escalation trial of MM-121 in combination with paclitaxel using a "3+3" design.

Detailed description

Successive cohorts of three or more patients were treated at escalating doses until a maximum tolerated dose/recommended phase 1 dose was identified. Once the maximum tolerated dose was identified, an Expansion Cohort was enrolled at that dose to further characterize safety and to explore pharmacodynamic endpoints.

Conditions

• Locally Advanced/Metastatic or Recurrent Ovarian Cancer, Fallopian Tube Cancer,
• Primary Peritoneal Cancer or Endometrial Cancer
• Locally Advanced/Metastatic Her2 Non Overexpressing Breast Cancer

Interventions

Type	Name	Description
DRUG	MM-121	increasing doses of MM-121 IV QW
DRUG	Paclitaxel	Paclitaxel - 80 mg/m2 IV QW

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-05-01
• Completion: 2014-07-01
• First posted: 2010-09-27
• Last updated: 2016-09-08
• Results posted: 2016-09-08

Locations

5 sites across 1 country: United States