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Monoclonal Antibodies

Cetuximab for Colorectal Cancer

Phase 2
Waitlist Available
Led By Norman Wolmark, MD
Research Sponsored by NSABP Foundation Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The tumor tissue must have been determined to be KRAS, NRAS, BRAF, PIK3CA (all RAS quadruple) wild-type by CLIA testing.
The ECOG performance status must be 0, 1 or 2. Patients must have the ability to swallow and retain oral medication. There must be documentation by CT scan, or MRI, that the patient has evidence of measurable metastatic disease per RECIST 1.1 criteria.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from initiation of neratinib plus cetuximab therapy to time of tumor assessment between cycles 6 and 7, which is usually 6 months after start of therapy
Awards & highlights

Study Summary

This trial will examine if adding neratinib to trastuzumab or cetuximab improves outcomes in patients with metastatic colorectal cancer that have a certain gene makeup.

Eligible Conditions
  • Colorectal Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initiation of neratinib plus trastuzumab therapy to time of tumor assessment, between cycle 6 and 7,which is usually six months after start of therapy.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from initiation of neratinib plus trastuzumab therapy to time of tumor assessment, between cycle 6 and 7,which is usually six months after start of therapy. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression free survival (PFS) with neratinib plus cetuximab therapy
Progression free survival with neratinib plus trastuzumab therapy
Secondary outcome measures
Clinical benefit rate
Frequency of adverse events assessed using CTCAE 4.0
Overall response rate to study therapy

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment2 Interventions
Patients with HER2 Wild Type or HER2 amplified with no prior anti-EGFR therapy will receive: • Neratinib daily + Cetuximab weekly until disease progression
Group II: Arm 1Experimental Treatment3 Interventions
Guardant360 test on blood from select patients with known HER2 status. Prior to assignment to Arm 1, HER2 test on blood obtained from Quadruple Wild-Type patients who received anti-EGFR therapy. Patients with HER2 amplified, HER2 Wild-Type or HER2 mutated will recieve: • Neratinib daily + Trastuzumab weekly until disease progression
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
2011
Completed Phase 3
~2480
Trastuzumab
2014
Completed Phase 4
~5190
Neratinib
2014
Completed Phase 2
~1970

Find a Location

Who is running the clinical trial?

Puma Biotechnology, Inc.Industry Sponsor
56 Previous Clinical Trials
9,757 Total Patients Enrolled
NSABP Foundation IncLead Sponsor
86 Previous Clinical Trials
136,953 Total Patients Enrolled
Norman Wolmark, MDPrincipal InvestigatorNSABP Foundation Inc
59 Previous Clinical Trials
83,682 Total Patients Enrolled

Frequently Asked Questions

~5 spots leftby Mar 2025