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Safety and Pharmacokinetic Study of MM-302 in Patients With Advanced Breast Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE1

Safety and Pharmacokinetic Study of MM-302 in Patients With Advanced Breast Cancer

A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, and Pharmacokinetic Clinical Study of Intravenously Administered MM-302 Monotherapy and in Combination With Trastuzumab With or Without Cyclophosphamide in Patients With Advanced HER2 Positive Breast Cancer

NCT01304797•Merrimack Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study is a Phase 1 and pharmacologic open-label dose-escalation trial using a "3+3" design. Successive cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified. Once the maximum tolerated dose is identified, an Expansion Cohort will be enrolled at that dose to further characterize safety and pharmacologic endpoints. Additional arms will be enrolled to explore the combination of MM-302 with trastuzumab or trastuzumab plus cyclophosphamide in patients with advanced HER2 positive breast cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Locally advanced/unresectable or metastatic breast cancer
•Eighteen years of age or above
•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 of 0 or 1
•Adequate bone marrow, hepatic, renal and cardiac function
•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-302

Exclusion Criteria

•Patients for whom potentially curative anticancer therapy is available
•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-302 or who have had hypersensitivity reactions to fully human monoclonal antibodies
•Received other recent antitumor therapy
•Pregnant or breast feeding
•Patients with any other medical or psychological condition, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results

Locations (5)

University of California San Francisco

San Francisco, California, United States

University of Indiana

Indianapolis, Indiana, United States

Dana Farber Cancer Center

Boston, Massachusetts, United States

Karmanos Cancer Center

Detroit, Michigan, United States

Washington University

St Louis, Missouri, United States

Key Dates

Start Date

March 1, 2011

Primary Completion Date

August 1, 2016

Completion Date

January 1, 2017

Last Updated

January 6, 2017

Enrollment

ESTIMATED participants

Conditions

Breast Cancer

Interventions

MM-302 Monotherapy

DRUG

MM-302 in combination with trastuzumab

DRUG

MM-302 in combination with trastuzumab q3w

DRUG

MM-302 in combination with trastuzumab and cyclophosphamide

DRUG

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

NCT05673200

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+2 more

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RECRUITINGPHASE1

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Pharmacokinetic Study of MM-302 in Patients With Advanced Breast Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer