A Study of CDX-011 (CR011-vcMMAE) in Patients With Advanced GPNMB-expressing Breast Cancer (EMERGE)
|Breast Cancer||Drug: CDX-011 Drug: "Investigator's Choice" chemotherapy||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase II, Randomized, Multicenter Study of CDX-011 (CR011-vcMMAE) in Patients With Advanced GPNMB-expressing Breast Cancer|
- Objective response rate [ Time Frame: 6 or more weeks following treatment initiation ]The objective response rate (ORR) is defined as the proportion of patients who achieve radiographic partial or complete response (PR or CR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guideline.
- Progression-free survival [ Time Frame: At least 18 months following treatment initiation ]Progression-free survival is defined as the time from randomization to the earlier of disease progression or death due to any cause.
- Adverse Events [ Time Frame: Usually following at least 1 cycle of study treatment (1 dose of CDX-011 or "Investigator's Choice" chemotherapy and 3 to 4 weeks of follow-up) ]The number and percentage of patients experiencing one or more adverse events will be summarized by treatment arm, relationship to study drug, and severity.
|Study Start Date:||July 2010|
|Study Completion Date:||November 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
CDX-011 (1.88 mg/kg) administered as an intravenous infusion on Day 1 of each 21 day cycle.
|Active Comparator: "Investigator's Choice" chemotherapy||
Drug: "Investigator's Choice" chemotherapy
Any of the following single-agent chemotherapy may be given at the discretion of the investigator, with a cycle length not to exceed four weeks: Capecitabine, Vinorelbine, Gemcitabine, Docetaxel, Paclitaxel, Albumin-bound paclitaxel, Doxorubicin HCL, Liposomal doxorubicin, Ixabepilone and Eribulin.
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 effectiveness and safety of CDX-011 in patients with advanced breast cancer that makes the GPNMB protein. To better assess this, the effect of CDX-011 will be compared to treatment with currently available cancer chemotherapy.
Eligible patients who enroll in the study will be randomly assigned by chance to receive treatment with CDX-011 or with a chemotherapy chosen by their study doctor from a list of currently available drugs ("Investigator's Choice" chemotherapy). For each three patients enrolled, two will receive CDX-011 and one will receive treatment with "Investigator's Choice". Patients initially assigned to "Investigator's Choice" chemotherapy may be offered treatment with CDX-011 if their cancer worsens during this initial treatment.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01156753
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