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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03446157 | Palbociclib and Cetuximab in Metastatic Colorectal Cancer | PHASE2 | COMPLETED | 24 | — | — | Mar 23, 2018 | Jan 26, 2026 | Mar 10, 2026 | 1 | United States |
Overall Response Rate (ORR) = CR + PR Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed assessed by Positron Emission Tomography (PET)- Computerized tomography (CT) scans. If the subject experienced a Complete Response (CR), the disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion new lesion.
| Arm | Type | Description |
|---|---|---|
| Open-label, single arm, Phase II | EXPERIMENTAL | Cetuximab and palbociclib |
| Name | Type | Description |
|---|---|---|
| Cetuximab | DRUG | Loading dose on day 1 of week 1 of 400 mg/m2 via IV over 2 hours Subsequent doses of 250 mg/m2 via IV over 1 hour weekly for 4 weeks (28 days) in combination with palbociclib |
| Palbociclib | DRUG | 125 mg taken orally once daily on days 1-21, then 7 days off |
Inclusion Criteria: 4.1.1 Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. 4.1.2 Age ≥ 18 years at the time of consent. 4.1.3 ECOG Performance Status of 0-2 4.1.4 Histologically-confirmed metastatic CRC 4.1.5 Measu...