Study of WNT974 in combination with LGX818 and cetuximab in patients with BRAF-mutant metastatic colorectal cancer (mCRC) and Wnt pathway mutations

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 55

Inclusion Criteria

•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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

Phase II only: Prior treatment with RAF inhibitors, Wnt pathway inhibitors, cetuximab, panitumumab, and/or other EGFR inhibitors. Note: Further enrollment to the study has been discontinued as of 21 March 2016. Therefore, references to phase II study design and objectives are no longer relevant.
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 Child-Pugh class B or C.
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral WNT974/LGX818.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Study of WNT974 in combination with LGX818 and cetuximab in patients with BRAF-mutant metastatic colorectal cancer (mCRC) and Wnt pathway mutations

Recruitment & Eligibility

Study & Design

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