drugset / Trial / NCT03446157
Palbociclib and Cetuximab in Metastatic Colorectal Cancer
Phase 2
Completed
24 enrolled
UNC Lineberger Comprehensive Cancer Center
Amgen · collabPfizer · collab
NaSingle-groupOpen-labelTreatment
Summary
This research study is designed to provide a better understanding of study drugs cetuximab (Erbitux®) and palbociclib when used in combination to treat patients with metastatic colon cancer.
Timeline
- Start
- 2018-03-23
- Primary completion
- 2023-05-29
- Completion
- 2026-01-26
Outcome
Missed primary endpoint
paper The 4-month DCR was 20%, which did not fulfill the prespecified 4-month DCR rate to continue. PMID 36288238 ↗
paper The four-month DCR was 41.7% (95% CI 15% to 72%) with median OS at 13.9 months and median PFS of 5.3 months, which did not meet the pre-specified endpoint of efficacy. PMID 40990835 ↗
Publications
- Sorah JD, Moore DT, Reilley MJ, Salem ME, Triglianos T, McRee AJ, Lee MS, Sanoff HK, Somasundaram AS. Phase II single-arm study of palbociclib and cetuximab in anti-EGFR naive patients with KRAS/NRAS/BRAF wild-type, metastatic colorectal cancer. Oncologist. 2025 Oct 1;30(10):oyaf305. doi: 10.1093/oncolo/oyaf305.
- Sorah JD, Moore DT, Reilley MJ, Salem ME, Triglianos T, Sanoff HK, McRee AJ, Lee MS. Phase II Single-Arm Study of Palbociclib and Cetuximab Rechallenge in Patients with KRAS/NRAS/BRAF Wild-Type Colorectal Cancer. Oncologist. 2022 Dec 9;27(12):1006-e930. doi: 10.1093/oncolo/oyac222.
- Noh JY, Lee IP, Han NR, Kim M, Min YK, Lee SY, Yun SH, Kim SI, Park T, Chung H, Park D, Lee CH. Additive Effect of CD73 Inhibitor in Colorectal Cancer Treatment With CDK4/6 Inhibitor Through Regulation of PD-L1. Cell Mol Gastroenterol Hepatol. 2022;14(4):769-788. doi: 10.1016/j.jcmgh.2022.07.005. Epub 2022 Jul 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Subject | Palbociclib | Small molecule | 125 mg | Oral |