Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer (METRIC)
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|ClinicalTrials.gov Identifier: NCT01997333|
Recruitment Status : Active, not recruiting
First Posted : November 28, 2013
Last Update Posted : March 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic gpNMB Over-expressing Triple Negative Breast Cancer||Drug: CDX-011 Drug: Capecitabine||Phase 2|
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
CDX-011 consists of an antibody attached to a drug, monomethyl auristatin E (MMAE), that can kill cancer cells. The antibody delivers the drug to cancer cells by attaching to a protein called glycoprotein NMB (gpNMB) that is expressed on the cancer cell. The MMAE is then released inside of the cell, where it interferes with cell growth and may lead to cell death.
This study will examine the efficacy and safety of CDX-011 in patients with advanced TNBC that makes the gpNMB protein. The effect of CDX-011 will be compared to treatment with capecitabine.
Eligible patients who enroll in the study will be randomly assigned (by chance) to receive treatment with CDX-011 or with capecitabine. For every three patients enrolled, two will receive CDX-011 and one will receive treatment with capecitabine. All patients enrolled in the study will be closely monitored to determine if their cancer is responding to treatment and for any side effects that may occur.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||327 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE)in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer (The METRIC Study)|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||November 30, 2017|
|Estimated Study Completion Date :||November 2018|
Active Comparator: Capecitabine
Capecitabine will be administered on Days 1 through 14 of each 21 day cycle.
Experimental: Drug: CDX-011
CDX-011 administered as an intravenous infusion on Day 1 of each 21 day cycle.
- Progression Free Survival (PFS) [ Time Frame: Evaluated every 6 - 9 weeks following treatment initiation ]PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause.
- Objective Response Rate (ORR) [ Time Frame: Evaluated every 6 - 9 weeks following treatment initiation ]ORR is defined as the proportion of patients who achieve best overall response of complete or partial response according to RECIST 1.1.
- Duration of Response (DOR) [ Time Frame: Evaluated every 6 - 9 weeks following treatment initiation ]
- Overall Survival (OS) [ Time Frame: During treatment and 3 months from end of treatment through end of study or approximately up to 5 years. ]
- Adverse Events (AE) [ Time Frame: Usually following at least 1 cycle of study treatment (1 dose of CDX-011 or capecitabine and until discontinuation of follow-up) ]The percentage of patients experiencing one or more adverse events will be summarized by treatment arm, relationship to study drug, and severity.
- Pharmacokinetic (PK) [ Time Frame: Following 1 dose of CDX-011. ]Concentration of the antibody-drug conjugate, total antibody and free MMAE will be determined.
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): NCT01997333
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