A Multicenter, Randomized, Open-label, 2-arm, Phase II Study With a Safety lead-in Phase Evaluating the Combination of Encorafenib and Cetuximab Versus Irinotecan/Cetuximab or Infusional 5-fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab in Chinese Patients With BRAF V600E Mutant Metastatic Colorectal Cancer. (NAUTICALCRC)

  • STATUS
    Recruiting
  • End date
    Apr 21, 2024
  • participants needed
    103
  • sponsor
    Pierre Fabre Medicament
Updated on 21 September 2022

Summary

Encorafenib is currently being developed (with or without binimetinib), in combination with cetuximab, for the treatment of adult patients with B-RAF proto-oncogene, serine/threonine kinase V600E mutant (BRAF V600E) metastatic colorectal cancer (mCRC), who have received prior systemic therapy.

Details
Condition BRAF V600E, Metastatic Colorectal Cancer
Treatment Cetuximab, FOLFIRI, Encorafenib
Clinical Study IdentifierNCT05004350
SponsorPierre Fabre Medicament
Last Modified on21 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The following inclusion criteria must be met for a participant to be eligible to undergo
molecular tumor prescreening
Chinese male or female participant with age ≥18 years at the time of informed consent
Histologically- or cytologically-confirmed colorectal cancer (CRC) that is metastatic
Eligible to receive cetuximab per Chinese approved label with regard to tumor Rat
Sarcoma Viral Oncogene Homologue (RAS) mutation status (i.e. approved for Rat Sarcoma
Viral Oncogene Homologue Wild Type(RAS wt) status)
Inclusion Criteria for Treatment Period
Able to provide a sufficient amount of representative tumor specimen for central
prospective laboratory testing of B-RAF Proto-oncogene, Serine/threonine Kinase (BRAF)
mutation status and also retrospective RAS wt status and Microsatellite Instability
study
(MSI) testing
The following inclusion criteria must be met for a participant to be eligible for this
NOTE: Other protocol defined Inclusion criteria may apply
Chinese male or female participant with age ≥18 years at time of informed consent
Histologically or cytologically confirmed CRC that is metastatic and unresectable at
time of study entry (i.e. not suitable for complete surgical resection at screening)
Presence of a BRAF V600E mutation in tumor tissue previously determined by a local
assay at any time before screening or by the central laboratory

Exclusion Criteria

Prior anti-Epidermal Growth Factor Receptor (anti-EGFR) treatment
More than two prior regimens in the metastatic setting
Participants meeting any of the following criteria are not eligible to undergo molecular
Leptomeningeal disease
tumor prescreening
Exclusion Criteria for Treatment Period
Symptomatic brain metastasis
Known contraindication to receive cetuximab or irinotecan at the planned dose
Leptomeningeal disease
according to the most recent cetuximab and irinotecan local label
Known history of Gilbert's syndrome or is known to have any of the following
NOTE: Other protocol defined Exclusion criteria may apply
genotypes: uridine 5'-diphospho-glucuronosyltransferase (UGT)1A1 _6/_ 6, UGT1A1 _28/_ 28
or UGT1A1 _6/_ 28
Prior treatment with any Proto oncogene Serine/threonine-Protein Kinase (RAF)
inhibitor, cetuximab, panitumumab or other EGFR inhibitors
Use of any herbal medications/supplements or any medications or foods that are
moderate or strong inhibitors or inducers of cytochrome P450 (CYP)3A4/5 ≤1 week before
the start of study intervention
Known history of acute or chronic pancreatitis within 6 months before the start of
study intervention
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