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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01304797
• Other study ID #: MM-302-02-01-01
• Status: Active, not recruiting
• Phase: Phase 1
• First received: February 24, 2011
• Last updated: January 4, 2017
• Start date: March 2011
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Merrimack Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: January 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• MM-302 Monotherapy
Escalating doses of MM-302 as a single agent
• MM-302 in combination with trastuzumab
Escalating MM-302 at an every 4 week dosing schedule, while the dose of trastuzumab is fixed at an every 2 week dosing schedule
• MM-302 in combination with trastuzumab q3w
Escalating MM-302 at an every 3 week dosing schedule, while the dose of trastuzumab is fixed at an every 3 week dosing schedule
• MM-302 in combination with trastuzumab and cyclophosphamide
Escalating MM-302 at an every 3 week dosing schedule, while the dose of trastuzumab and cyclophosphamide is fixed at an every 3 week dosing schedule

Locations

Country	Name	City	State
United States	Dana Farber Cancer Center	Boston	Massachusetts
United States	Karmanos Cancer Center	Detroit	Michigan
United States	University of Indiana	Indianapolis	Indiana
United States	University of California San Francisco	San Francisco	California
United States	Washington University	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Merrimack Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The severity and the number of adverse events related to escalating doses of the MM-302.		12 months	Yes
Primary	The severity and the number of adverse events related to escalating doses of the MM-302 in combination with trastuzumab with or without cyclophosphamide		12 months	Yes
Secondary	Objective response rate of MM-302		12 months	No
Secondary	The pharmacokinetics of MM-302 as determined by measuring AUC, Tmax and Cmax		12 months	No
Secondary	Immunogenicity of MM-302 by confirming whether MM-302 elicits an immune response or not		12 months	No