Safety and Pharmacokinetic Study of MM-302 in Patients With Advanced Breast Cancer
This study is currently recruiting participants.
Verified May 2013 by Merrimack Pharmaceuticals
Sponsor:
Merrimack Pharmaceuticals
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01304797
First received: February 24, 2011
Last updated: May 10, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: 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 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Merrimack Pharmaceuticals:
Primary Outcome Measures:
- The severity and the number of adverse events related to escalating doses of the MM-302. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- The severity and the number of adverse events related to escalating doses of the MM-302 in combination with trastuzumab with or without cyclophosphamide [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Objective response rate of MM-302 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- The pharmacokinetics of MM-302 as determined by measuring AUC, Tmax and Cmax [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Immunogenicity of MM-302 by confirming whether MM-302 elicits an immune response or not [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 75 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: MM-302 |
Drug: MM-302 Monotherapy
Escalating doses of MM-302 as a single agent
|
| Experimental: MM-302 in Combination with Trastuzumab |
Drug: 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
Other Name: Herceptin
|
| Experimental: MM-302 in Combination with Trastuzumab q3w |
Drug: 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
Other Name: herceptin
|
| Experimental: MM-302 in Combination with Trastuzumab and Cyclophosphamide |
Drug: 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
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01304797
Contacts
| Contact: Victor Moyo, MD | 617-441-1007 |
Locations
| United States, California | |
| University of California San Francisco | Recruiting |
| San Francisco, California, United States | |
| United States, Indiana | |
| University of Indiana | Recruiting |
| Indianapolis, Indiana, United States | |
| United States, Massachusetts | |
| Dana Farber Cancer Center | Recruiting |
| Boston, Massachusetts, United States | |
| United States, Michigan | |
| Karmanos Cancer Center | Recruiting |
| Detroit, Michigan, United States | |
| United States, Missouri | |
| Washington University | Not yet recruiting |
| St. Louis, Missouri, United States | |
Sponsors and Collaborators
Merrimack Pharmaceuticals
More Information
No publications provided
| Responsible Party: | Merrimack Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01304797 History of Changes |
| Other Study ID Numbers: | MM-302-02-01-01 |
| Study First Received: | February 24, 2011 |
| Last Updated: | May 10, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Merrimack Pharmaceuticals:
|
MM302 Breast Cancer Locally advanced/unresectable metastatic |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Trastuzumab Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |
ClinicalTrials.gov processed this record on May 23, 2013