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

Sumitomo Pharma Co., Ltd. (Industry)
Overall Status
CT.gov ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Anticipated Enrollment :
60 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
A Phase I Study of BBI503 Monotherapy in Patients With Advanced Solid Tumors, or BBI503 Plus Sorafenib Combination Therapy in Patients With Advanced Hepatocellular Carcinoma
Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
Oct 1, 2018
Actual Study Completion Date :
Oct 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: BBI503, BBI503 and Sorafenib

Drug: BBI503

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

Outcome Measures

Primary Outcome Measures

  1. Determine of the Maximum Tolerated Dose (MTD) of BBI503 monotherapy and in combination with Sorafenib by assessing dose-limiting toxicities (DLTs) [36 days]

  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Approximately 7 months]

  3. Pharmacokinetic profile of BBI503 [37 days]

Secondary Outcome Measures

  1. Assessment of the preliminary anti-tumor activity by performing tumor assessments approximately every 8 weeks [6 months]

    The radiologic assessments will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  2. Progression Free Survival [Approximately 7 month]

    The time the participant stays on study until progression will be measured and recorded.

  3. Overall Survival [Approximately1 year]

    Participants follow-up for overall survival will occur. Maximum follow-up time is 1 year after the initial administration of the last subject.

Eligibility Criteria


Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
Accepts 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

Contacts and Locations


Site City State Country Postal Code
1 5 Sites Chiba, Etc. Japan

Sponsors and Collaborators

  • Sumitomo Pharma Co., Ltd.


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Sumitomo Pharma Co., Ltd.
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • DA101003
First Posted:
Feb 3, 2015
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 12, 2022