CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 153 target
Drug / intervention
Panitumumab 20 milligram/ML +2 morebiological
Likely dose
Panitumumab 20 milligram/MLfrom record
Key inclusion· 7
  • ✓Histologically confirmed adenocarcinoma of colon or rectum
  • ✓Metastatic colorectal cancer with at least one measurable lesion per RECIST 1.1
  • ✓Metastases unresectable or patient unable/unwilling to undergo surgery
  • ✓RAS wild-type (KRAS exons 2,3,4 and NRAS exons 2,3,4) proven by validated test
Key exclusion· 30
  • ✕Prior systemic therapy for metastatic disease
  • ✕Known brain metastasis
  • ✕NYHA Class III or greater heart failure
  • ✕Myocardial infarction within 6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05007132
NCT05007132Phase 2RecruitingOn TrackUpdated 28mo ago
Long Recruiting
CompareCT.gov

Prospective, Randomized, Open, Multicenter Phase II Trial to Investigate the Efficacy of Trifluridine/Tipiracil Plus Panitumumab Versus Trifluridine/Tipiracil Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer: FIRE-8; AIO-KRK/YMO-0519

Dominik Paul Modest·interventional·Posted Aug 16, 2021·Updated Feb 15, 2024

In Brief

A Phase 2 clinical trial evaluating Panitumumab 20 milligram/ML, Bevacizumab, and 1 other intervention for Metastatic Colorectal Cancer. Currently recruiting, targeting 153 participants across 1 site.

Detailed Summary

FIRE-8 is a prospective, randomized, open label, multicenter phase II clinical trial. To evaluate the effecacy of trifluridine / tipiracil and panitumumab (Arm A) compared to trifluridine / tipiracil and bevacizumab (Arm B), participants will be randomly assigned to either Arm A or Arm B for the treatment of metastatic colorectal cancer. The primary objectives of this study is to compare the effecacy of treatment with trifluridine / tipiracil plus panitumumab versus trifluridine / tipiracil plus bevacizumab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Colorectal Cancer
CountriesGermany
Collaborators--

Timeline

Phase 2Recruiting
202220232024202520262027202820292030203120322033
First PostedAug 16, 2021
Enrollment StartDec 17, 2021
Primary CompletionDec 1, 2029
Study CompletionDec 1, 2032
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 4.9 years agoPrimary completion in 3.4 years

Interventions

Panitumumab 20 milligram/MLbiological

Participants receive Panitumumab at 6mg/ kg intravenously (IV) on Day 1 and 15 of each 28-day cycle. Treatment is continued until occurrence of progression according to RECIST 1.1 criteria as evaluated by the investigator or unacceptable toxicity.

Bevacizumabbiological

Participants receive bevacizumab at 5 mg/ kg intravenously (IV) on Day 1 and 15 of each 28-day cycle. Treatment is continued until occurrence of progression according to RECIST 1.1 criteria as evaluated by the investigator or unacceptable toxicity.

Trifluridine/Tipiracil Hydrochloridedrug

Participants receive Trifluridine/tipiracil at 35 mg/m² BSA, twice daily, orally on days 1-5 and 8-12