MM-111 in Combination With Herceptin in Patients With Advanced Her2 Amplified, Heregulin Positive Breast Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Merrimack Pharmaceuticals.
Recruitment status was Active, not recruiting
Information provided by (Responsible Party):
First received: March 30, 2010
Last updated: June 6, 2012
Last verified: June 2012
This is an open-label Phase 1 trial of MM-111 in combination with Herceptin.
HER2 Amplified Breast Cancer
Metastatic or Advanced Breast Cancer
Drug: MM-111 and Herceptin
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- To assess the safety of MM-111 + Herceptin in combination [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To determine the recommended Phase 2 doses of MM-111 + Herceptin in combination [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||November 2012 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients must have histologically or cytologically confirmed advanced breast cancer that is amplified for HER2, based on archived tumor biopsy (IHC 2+ or greater)
- Patients must have histologically or cytologically confirmed advanced breast cancer that is heregulin positive based on fresh tumor tissue biopsy
- The patient's cancer must have recurred, progressed or not responded to standard chemotherapy or other standard treatment. Prior therapies may include but are not limited to Herceptin, Tykerb (lapatinib), anthracyclines, and taxanes
- Patients must be ≥ 18 years of age
- Patients or their legal representatives must be able to understand and sign an informed consent
- Patients may have measurable (per RECIST 1.1) or non-measurable tumor(s) (for Phase 1)
- Patients should have ECOG Performance Score (PS) 0, 1 or 2 (for Phase 1).
- Patients should have a life expectancy of at least 12 weeks
- Patients must have adequate bone marrow reserves
- Patients must have adequate hepatic function
- Patients must have adequate renal function
- Patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy.
- Women of childbearing potential as well as fertile men and their partners must agree 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-111.
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097460
|Indiana University (IUPUI)
|Indianapolis, Indiana, United States, 46202 |
|Massachusetts General Hospital
|Boston, Massachusetts, United States, 02114 |
|Huntsman Cancer Institute
|Salt Lake City, Utah, United States, 84112 |
||Michaela Higgins, MD
||Massachusetts General Hospital
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 30, 2010
||June 6, 2012
||United States: Food and Drug Administration
Keywords provided by Merrimack Pharmaceuticals:
Advanced Breast Cancer
Metastatic Breast Cancer
HER2 Positive Breast Cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 18, 2014
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