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Completed

NCT Number: NCT03516071

A Phase 2 Study of Brivanib in Chinese Patients With Previously Treated Advanced HCC

This is a Phase 2, Open-label, Randomized, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Brivanib in Patients with Previously Treated Advanced Hepatocellular Carcinoma.

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Key information

Conditions

Hepatocellular Carcinoma (HCC) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anhui Provincial Hospital, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-75 years, male or female
  • Histologically or cytologically confirmed or the clinical diagnosis standard confirmed hepatocellular carcinoma (HCC) patients
  • Failure or intolerance to prior treatment with chemotherapy and/or targeted therapy
  • Liver function status Child-Pugh Class A or B (score≤7)
  • ECOG Performance Status score 0 or 1
  • Patients must have adequate bone marrow, renal and hepatic function

Exclusion criteria

  • Known history or symptomatic metastatic brain
  • Uncontrolled moderate and severe ascites
  • With bleeding tendency and thrombosis history
  • Known history of severe cardiovascular disease
  • Uncontrollable active infections (≥CTCAE Grade 2)
  • Pregnant or breastfeeding women

Treatment and study plan

Brivanib 800 mg, QD

Drug

Brivanib Alaninate 800 mg QD, PO

Brivanib 400 mg, BID

Drug

Brivanib Alaninate 400 mg BID, PO

Primary outcomes

  1. Disease control rate (DCR) at 3 months from randomization

    Time frame: 12 weeks from randomization

    Defined as the percentage of patients with complete response, partial response, or stable disease at 12 weeks from randomization by RECIST v1.1.

  2. Time to Progress (TTP)

    Time frame: 12 weeks from randomization

    Defined as the time from random assignment to radiologic disease progression.

Secondary outcomes

  1. Disease control rate (DCR) at 6 months from randomization

    Time frame: 24 weeks from randomization

    Defined as the percentage of patients with complete response, partial response, or stable disease at 24 weeks from randomization by RECIST v1.1.

  2. Progression-free survival (PFS)

    Time frame: 24 weeks from randomization

    Defined as the time from random assignment until the date of disease progression or death as a result of any cause.

  3. Objective response rate (ORR)

    Time frame: 24 weeks from randomization

    Defined as the proportion of randomized patients with CR or PR as the optimal response in each treatment group assessed by use of RECIST 1.1 criteria

  4. Overall survival (OS)

    Time frame: 24 weeks from randomization

    Refers to the duration from randomization to death from any cause

Sponsors and collaborators

Lead sponsor

Zai Lab (Shanghai) Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Open-label, Phase II Clinical Study to Evaluate the Efficacy and Safety of Brivanib Alaninate (ZL-2301) Combined With Best Supportive Care (BSC) and Pharmacokinetic Profiles of Brivanib Alaninate in Patients With Advanced Hepatocellular Carcinoma (HCC) Failed or Intolerant of Standard Systemic Chemotherapy and/or Sorafenib

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
May 4, 2018
Registry last updated
Sep 4, 2019

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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