Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01156753 | A Study of CDX-011 (CR011-vcMMAE) in Patients With Advanced GPNMB-expressing Breast Cancer | PHASE2 | COMPLETED | 120 | — | — | Jul 1, 2010 | Nov 1, 2012 | Jul 2, 2017 | 24 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| CDX-011 | EXPERIMENTAL | - |
| "Investigator's Choice" chemotherapy | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| CDX-011 | DRUG | CDX-011 (1.88 mg/kg) administered as an intravenous infusion on Day 1 of each 21 day cycle. |
| "Investigator's Choice" chemotherapy | DRUG | 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. |
Inclusion Criteria: Among other criteria, patients must meet all of the following conditions to be eligible for the study: 1. 18 years of age or older. 2. Locally advanced or metastatic breast cancer. 3. Previous treatment with at least two but no more than seven prior chemotherapy treatments for ...