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

NCT02354898 | Completed Phase 1

• 1 other identifier: DA101003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Solid Tumors; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (3)

• Determine of the Maximum Tolerated Dose (MTD) of BBI503 monotherapy and in combination with Sorafenib by assessing dose-limiting toxicities (DLTs)

  36 days

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  Approximately 7 months

• Pharmacokinetic profile of BBI503

  37 days

Secondary Outcomes (3)

• Assessment of the preliminary anti-tumor activity by performing tumor assessments approximately every 8 weeks

  6 months

• Progression Free Survival

  Approximately 7 month

• Overall Survival

  Approximately1 year

Study Arms (1)

BBI503, BBI503 and Sorafenib

EXPERIMENTAL

Drug: BBI503; Drug: Sorafenib

Interventions

BBI503 DRUG

BBI503, BBI503 and Sorafenib

Sorafenib DRUG

Sorafenib 400mg twice daily (800mg total daily dose)

BBI503, BBI503 and Sorafenib

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sumitomo Pharma Co., Ltd.: lead

Study Sites (1)

5 Sites

Chiba, Etc., Japan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: February 3, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

JP (1)