Clareo Health | Study of WNT974 in Combination With LGX818 and Cetuximab in Patients With BRAF-mutant Metastatic Colorectal Cancer (mCRC) and Wnt Pathway Mutations
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Array BioPharma
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female aged ≥ 18 years
Histological or cytological confirmed metastatic colorectal cancer
Written documentation of KRAS wild-type status and BRAFV600-mutation with RNF43 mutation and/or RSPO fusion
Progression of disease after at least one prior standard of care regimen or intolerant to irinotecan based regimens
Availability of a representative tumor specimen (primary or metastatic, archival or newly obtained)
Measurable disease as per RECIST v1.1
Eastern cooperative oncology group (ECOG) performance status ≤ 2
You may not be if
Phase II only: Prior treatment with RAF inhibitors, Wnt pathway inhibitors, cetuximab, panitumumab, and/or other EGFR inhibitors
Symptomatic brain metastasis. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid and anti-epileptic therapy are allowed to enroll
Current treatment with medications or consuming foods that are strong inhibitors or inducers of CYP3A4/5 or herbal medications and that cannot be discontinued at least one week prior to the start of treatment.
Symptomatic or untreated leptomeningeal disease
Acute or chronic pancreatitis
Clinically significant cardiac disease
Patients with any of the following laboratory values at Screening/baseline
* Absolute neutrophil count (ANC) \<1,500/mm3
* Platelets \< 100,000/mm3
* Hemoglobin \< 9.0 g/dL
* Serum creatinine \>1.5 x ULN or calculated or directly measured CrCl \< 50% lower limit of normal
* Serum total bilirubin \>1.5 x ULN
* AST/SGOT and/or ALT/SGPT \> 2.5 x ULN, (\> 5 x ULN if liver metastases present)
Patients with impaired hepatic function as defined by Childs-Pugh class B or C
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral WNT974/LGX818
