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| Sponsor: | Merrimack Pharmaceuticals |
|---|---|
| Information provided by (Responsible Party): | Merrimack Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01097460 |
Purpose
This is an open-label Phase 1 trial of MM-111 in combination with Herceptin.
| Condition | Intervention | Phase |
|---|---|---|
|
HER2 Amplified Breast Cancer Metastatic or Advanced Breast Cancer |
Drug: MM-111 and Herceptin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | MM-111-02-12-02: A Phase 1 Study of MM-111 in Combination With Herceptin in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Breast Cancer |
| Estimated Enrollment: | 39 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MM-111 + Herceptin
MM-111 will be combined with Herceptin
|
Drug: MM-111 and Herceptin
For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV
Other Name: Trastuzumab
|
Phase 1: Safety and tolerability of the MM-111 + Herceptin combination will be evaluated and the recommended Phase 2 dose will be determined.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients who have received other recent antitumor therapy including:
Contacts and Locations| United States, Indiana | |
| Indiana University (IUPUI) | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Jessica Sollars 371-278-5117 jlsherma@iupiu.edu | |
| Principal Investigator: Kathy Miller, MD | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Karleen Habin, RN 617-726-1922 | |
| Principal Investigator: Michaela Higgins, MD, MRCPI | |
| United States, Utah | |
| Huntsman Cancer Institute | Recruiting |
| Salt Lake City, Utah, United States, 84112 | |
| Contact: Karen Welborne 801-581-7168 Karen.welborne@hci.utah.edu | |
| Principal Investigator: Sunil Sharma, MD, FACP | |
| Principal Investigator: | Michaela Higgins, MD | Massachusetts General Hospital |
More Information
| Responsible Party: | Merrimack Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01097460 History of Changes |
| Other Study ID Numbers: | MM-111-02-12-02 |
| Study First Received: | March 30, 2010 |
| Last Updated: | October 17, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
HER2/HER3 Bispecific Antibody Breast Cancer Advanced Breast Cancer |
Metastatic Breast Cancer HER2 Positive Breast Cancer Trastuzumab Herceptin |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Trastuzumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |