A phase Ib/II multi-center, open label, dose escalation study of WNT974, LGX818 and cetuximab in patients with BRAFV600-mutant metastatic colorectal cancer harboring Wnt pathway mutations

Array BioPharma Inc.0 个研究点目标入组 20 人开始时间: 2014年10月22日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•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

•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 Childs-Pugh class B or C.
•Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral WNT974/LGX818.

发起方