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

ClinicalTrials.gov ID: NCT01304797

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT01304797
Recruitment status: Not listed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Merrimack Pharmaceuticals; Industry
Enrollment: 75 participants

Conditions and interventions

Conditions

Breast Cancer

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 2011 (Type not available)
Primary completion: Aug 2016 (Actual)
Completion: Jan 2017 (Estimated)
Last update posted: Jan 6, 2017

2011 – 2017

United States locations

U.S. sites: 5
U.S. states: 5
U.S. cities: 5

Facility	City	State	ZIP	Site status
University of California San Francisco	San Francisco	California	—	—
University of Indiana	Indianapolis	Indiana	—	—
Dana Farber Cancer Center	Boston	Massachusetts	—	—
Karmanos Cancer Center	Detroit	Michigan	—	—
Washington University	St Louis	Missouri	—	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01304797, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jan 6, 2017 · Synced Nov 15, 2026