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A Study of MM-121 in Combination With Paclitaxel in Patients With Advanced Gynecologic and Breast Cancers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT01209195•Merrimack Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Cytological or histological confirmation of locally advanced/metastatic or recurrent epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or endometrial cancer; OR, cytological or histological confirmation of locally advanced /metastatic Her2 non-overexpressing breast cancer
•Eighteen years of age or above
•Candidates for chemotherapy
•Able to understand and sign an informed consent (or have a legal representative who is able to do so)
•Measurable disease according to RECIST v1.1
•ECOG Performance Score (PS) of ≤ 2
•Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-121

Exclusion Criteria

•Prior radiation therapy to \>25% of bone marrow-bearing areas
•Evidence of any other active malignancy
•Active infection or fever\> 38.5°C during screening visits or on the first scheduled day of dosing
•Symptomatic CNS disease
•Known hypersensitivity to any of the components of MM-121 or who have had hypersensitivity reactions to fully human monoclonal antibodies
•Received treatment, within 30 days prior to the first scheduled day of dosing, with any investigational agents that have not received regulatory approval for any indication or disease state
•Pregnant or breast feeding

Locations (5)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, United States

Pinnacle Oncology Hematology

Scottsdale, Arizona, United States

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Cancer Care Associates of Fresno

Fresno, California, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Key Dates

Start Date

October 1, 2010

Primary Completion Date

May 1, 2014

Completion Date

July 1, 2014

Last Updated

September 8, 2016

Enrollment

ACTUAL participants

Conditions

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

Interventions

MM-121

DRUG

Paclitaxel

DRUG