Phase 2 Study of the Monoclonal Antibody MGAH22 (Margetuximab) in Patients With Relapsed or Refractory Advanced Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01828021|
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : August 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: Margetuximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm, Open-Label, Phase 2 Study of MGAH22 (Fc-optimized Chimeric Anti-HER2 Monoclonal Antibody) in Patients With Relapsed or Refractory Advanced Breast Cancer Whose Tumors Express HER2 at the 2+ Level by Immunohistochemistry and Lack Evidence of HER2 Gene Amplification by FISH|
|Actual Study Start Date :||March 2013|
|Actual Primary Completion Date :||December 7, 2016|
|Actual Study Completion Date :||April 14, 2017|
Monotherapy of Anti-HER2 monoclonal antibody
Anti-HER2 monoclonal antibody
Other Name: MGAH22
- Response [ Time Frame: Cycle 2, Day 21 ]Response based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria based on Cycle 2, Day 21 computed tomography (CT) scans. This study will employ a Simon two-stage optimum design in which an initial cohort of 21 patients will be treated with margetuximab. If two or more responses (partial or complete response) are seen at the first tumor re-evaluation on day 21 of Cycle 2, the study will be expanded to include up to 41 patients (20 additional patients in Cohort 2, the second stage of the study) in order to determine whether further development of the drug is warranted (5 or more responses in 41 evaluable patients).
- Response Rate [ Time Frame: Following Cycle 2 Day 21 of first 21 patients and following Cycle 2 Day 21 of all 41 patients ]Response rate is the proportion of patients achieving a best response of complete response or partial response when such responses are confirmed at least 28 days after initial observation of response.
- Duration of Response [ Time Frame: From day of initial response until the date of first documented progression or death, assessed up to 100 months ]Duration of response is defined as the number of days from initial response to date of disease progression or death. A patient's response duration will be censored if at the time of study completion or study withdrawal, response is ongoing.
- Progression-free survival [ Time Frame: Study Day 1 to date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]Progression-free survival (PFS) is defined as the number of days from the date of study enrollment (Study Day 1) to the date of disease progression, death, study completion or study withdrawal, whichever occurs first. A patient's PFS will be censored if at the time of study completion or study withdrawal, disease progression or death has not occurred.
- Overall Survival [ Time Frame: Study Day 1 to date of death from any cause assessed up to 100 months ]Overall survival (OS) is defined as the number of days from the date of study enrollment (Study Day 1) to the date of death (by any cause) or last observation, whichever occurs first. A patient's OS will be censored if at the time of study completion or study withdrawal, the patient remains alive.
- Safety [ Time Frame: Time of consent to 28 days after last MGAH22 administration ]Adverse events (AEs), serious adverse events (SAEs), Electrocardiogram (ECG) monitoring, monitoring for development of anti-drug antibodies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828021
|United States, California|
|University of California San Francisco|
|San Francisco, California, United States, 94115|
|Stanford, California, United States, 94305|
|United States, Florida|
|Florida Cancer Research Institute|
|Plantation, Florida, United States, 33324|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Massachusetts|
|Tufts Cancer Center|
|Boston, Massachusetts, United States, 02111|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Principal Investigator:||Mark D. Pegram, M.D.||Stanford University|
|Study Director:||Jan K Davidson-Moncada, M.D.||MacroGenics|