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NCT Number: NCT02354898

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

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.

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Key information

Conditions

Advanced Solid Tumors Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Hepatocellular Carcinoma Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

5 Sites

Chiba, Etc., Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BBI503

Drug

Sorafenib

Drug

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

Primary outcomes

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

    Time frame: 36 days

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

    Time frame: Approximately 7 months

  3. Pharmacokinetic profile of BBI503

    Time frame: 37 days

Secondary outcomes

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

    Time frame: 6 months

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

  2. Progression Free Survival

    Time frame: Approximately 7 month

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

  3. Overall Survival

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 3, 2015
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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