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Palbociclib and Cetuximab in Metastatic Colorectal Cancer

NCT03446157 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-03-10

Study results available
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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.

Conditions

  • Cancer of the Colon
  • Colon Cancer
  • Colon Neoplasms
  • Colonic Cancer
  • Neoplasms, Colonic

Interventions

DRUG

Cetuximab

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

DRUG

Palbociclib

125 mg taken orally once daily on days 1-21, then 7 days off

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Hanna Sanoff · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-23
Primary Completion
2023-05-29
Completion
2026-01-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03446157 on ClinicalTrials.gov