Status:
COMPLETED
Study of WNT974 in Combination With LGX818 and Cetuximab in Patients With BRAF-mutant Metastatic Colorectal Cancer (mCRC) and Wnt Pathway Mutations
Lead Sponsor:
Array BioPharma
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to assess the safety and anti-tumor activity of the triple combination of WNT974, LGX818 and cetuximab in BRAFV600-mutant mCRC with RNF43 mutations or RSPO fusions. The d...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02278133
Start Date
December 1 2014
End Date
June 23 2017
Last Update
October 9 2017
Active Locations (19)
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1
Memorial Sloan-Kettering Cancer Center (MSKCC) MSKCC (3)
New York, New York, United States, 10065
2
Medical University of South Carolina Oncology Dept
Charleston, South Carolina, United States, 29425
3
University of Texas/MD Anderson Cancer Center Onc. Dept,
Houston, Texas, United States, 77030-4009
4
University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc
Madison, Wisconsin, United States, 53792-6164