Study Summary
This trial is comparing panitumumab to the standard of care for treating patients with colorectal cancer that has spread and is negative for RAS wild-type.
Eligible Conditions
- Stage IVA Rectal Cancer
- Stage IIIA Colorectal Cancer
- Stage IIIB Colon Cancer
- Stage IIIB Colorectal Cancer
- Stage IVB Colon Cancer
- Stage III Colorectal Cancer
- Stage IIIA Colon Cancer
- Stage IV Colon Cancer
- Colon Cancer
- Stage IVA Colon Cancer
- Stage IIIA Rectal Cancer
- Stage IVB Rectal Cancer
- Stage III Rectal Cancer
- Stage IIIC Rectal Cancer
- Stage III Colon Cancer
- Stage IVC Colorectal Cancer
- Unresectable Colon Cancer
- Unresectable Colorectal Cancer
- Metastatic Rectal Cancer
- Stage IVC Colon Cancer
- Stage IIIB Rectal Cancer
- Colorectal Cancer
- Stage IVA Colorectal Cancer
- Stage IV Colorectal Cancer
- Stage IV Rectal Cancer
- Stage IVB Colorectal Cancer
- Stage IVC Rectal Cancer
- Unresectable Rectal Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: 3 years
3 years
Overall survival (OS)
Progression free survival (PFS)
At 4 months
Clinical benefit rate
Baseline, at restaging, and at disease progression
Cell free tumor deoxyribonucleic acid (cfDNA)
Up to 2 years
Overall response rate (ORR)
Up to 3 years
Circulating protein studies
Incidence of adverse events
Patient-reported quality of life
Tumor tissue studies
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
Arm B (regorafenib, trifluridine and tipiracil hydrochloride)
1 of 2
Arm A (panitumumab)
1 of 2
Active Control
Experimental Treatment
84 Total Participants · 2 Treatment Groups
Primary Treatment: Panitumumab · No Placebo Group · Phase 2
Arm A (panitumumab)Experimental Group · 3 Interventions: Panitumumab, Quality-of-Life Assessment, Questionnaire Administration · Intervention Types: Biological, Other, Other
Arm B (regorafenib, trifluridine and tipiracil hydrochloride)ActiveComparator Group · 4 Interventions: Quality-of-Life Assessment, Questionnaire Administration, Trifluridine and Tipiracil Hydrochloride, Regorafenib · Intervention Types: Other, Other, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Panitumumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
Who is running the clinical trial?
Academic and Community Cancer Research UnitedLead Sponsor
50 Previous Clinical Trials
5,165 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,072 Previous Clinical Trials
41,128,834 Total Patients Enrolled
John H StricklerPrincipal InvestigatorAcademic and Community Cancer Research United
4 Previous Clinical Trials
662 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Your Guardant360 blood collection date must be within the last 90 days prior to randomization.
If no Guardant360 test results are available, enrolling in ACCRU_GI-1611 (COLOMATE) is highly recommended.
You have not received EGFR therapy (cetuximab or panitumumab) within the past 90 days.
You are at least 18 years old.
You have histologically and/or cytologically verified metastatic and/or inoperable adenocarcinoma of the colon or rectum.
Tumor tissue taken from primary or metastatic site before receiving anti EGFR therapy must demonstrate documented wild-type KRAS and NRAS (codons 12, 13, 59, 61, 117, and 146) as well as BRAF codon 600.
You are taking a fluoropyrimidine medication, such as 5-fluorouracil or capecitabine.
You are taking Oxaliplatin.
You are taking irinotecan.
You have been prescribed a VEGF-targeting monoclonal antibody such as bevacizumab, ramucirumab, or aflibercept.
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Conditions
Cancer Related
Treatments