A Study of BBI503 in Advanced Solid Tumors, or BBI503/ Sorafenib in Advanced Hepatocellular Carcinoma

Sumitomo Pharma

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumors

Hepatocellular Carcinoma

Treatments

Drug: Sorafenib

Drug: BBI503

Study type

Interventional

Funder types

Industry

Identifiers

NCT02354898

DA101003

Details and patient eligibility

About

This is an open-label, multicenter, phase 1 dose escalation study of BBI503 monotherapy, or BBI503 in combination with Sorafenib. This study population is adult patients with advanced solid tumors in monotherapy, or adult patients with advanced hepatocellular carcinoma in combination therapy.

Enrollment

60 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provision of written informed consent.
≥ 20 years of age
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last BBI503 dose
Females of childbearing potential must have a negative serum pregnancy test
Adequate organ function
Life expectancy ≥ 3 months

Exclusion criteria

Any known symptomatic or untreated brain metastases
Pregnant or breastfeeding
Crohn's disease, ulcerative colitis extensive gastric and small intestine resection
Unable or unwilling to swallow BBI503 daily
Uncontrolled concurrent disease
Received other investigational drugs within 4 weeks prior to first dose
Prior treatment with BBI503