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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00503685 | Study Using IMC-A12 (Cixutumumab) With or Without Cetuximab in Participants With Metastatic Colorectal Cancer Who Have Failed a Treatment Regimen That Consisted of a Prior Anti-EGFR Therapy | PHASE2 | COMPLETED | 65 | — | — | Jun 1, 2007 | Mar 1, 2009 | Jun 6, 2018 | 4 | United States |
ORR is the percentage of participants with a confirmed CR or PR, as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions. ORR is calculated as a total number of participants with CR or PR from start of the treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.
| Arm | Type | Description |
|---|---|---|
| IMC-A12 | EXPERIMENTAL | Administered every 2 weeks |
| IMC-A12 + cetuximab | EXPERIMENTAL | Administered every 2 weeks |
| IMC-A12 + cetuximab [Kirsten rat sarcoma (K-ras) wild-type] | EXPERIMENTAL | Participants who have experienced confirmed partial response (PR) or stable disease (SD) ≥ 24 weeks on a prior anti-EGFR-containing therapy followed by disease progression are enrolled in this arm. |
| Name | Type | Description |
|---|---|---|
| IMC-A12 | BIOLOGICAL | 10 milligrams/kilogram (mg/kg) intravenous infusion every 2 weeks. |
| cetuximab | BIOLOGICAL | Participants will receive cetuximab 500 milligrams/square meter (mg/m²) intravenous over 2 hours every 2 weeks. |
Inclusion Criteria * The participant has histologically or cytologically-confirmed colorectal cancer with metastatic disease documented on diagnostic imaging studies * The participant has measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (l...