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Completed

NCT Number: NCT00999882

Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of Tor Kinase Inhibitor in Liver Cancer Patients

The main purpose of the study is to establish a safe dose of AZD8055 in patients with mild or moderate liver disease by providing information on any potential side effects this drug may cause and collecting data about how hepatocellular carcinoma responds to the drug.

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Key information

Conditions

Cancer Adenocarcinoma Advanced Hepatocellular Carcinoma 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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Hong Kong

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Advanced stage Hepatocellular Carcinoma (HCC) confirmed by cytology or histology
  • Advanced stage Hepatocellular Carcinoma (HCC) or metastatic Hepatocellular Carcinoma (HCC) which is inoperable and incurable with standard available treatments
  • Relatively good overall health other than cancer (WHO performance status (0-2)

Exclusion criteria

  • Patients with severe heart conditions, or those who have had heart surgery such as coronary artery bypass graft within the last 6 months, or patients with uncontrolled high blood pressure despite medical management.
  • Patients must not have received any other anti cancer therapy including TACE within 21 days of entering the trial
  • Patients must not have received a liver transplant.

Treatment and study plan

AZD8055

Drug

Dose escalation phase: Tablet taken orally, a single dose of AZD8055 on Day 1, followed by twice daily continuous dosing from Day 3 onwards, till discontinuation or withdrawal.Expansion phase: twice daily continuous dosing from Day 1 onwards till discontinuation or withdrawal.

Primary outcomes

  1. Safety and tolerability (Adverse events, vital signs, ECG, chemistry, haematology, urinalysis, physical examination)

    Time frame: Every week for Cycle 1 and 2, every 2 weeks from cycle 3 onwards, every 4 weeks from cycle 7 onwards

  2. Evaluate the pharmacokinetics of AZD8055 following both single and multiple dosing

    Time frame: Blood samples on 6 occasions during the first Cycle of the study (28 days)

Secondary outcomes

  1. To make a preliminary assessment of efficacy

    Time frame: Every 4 weeks

  2. To investigate the possible relationship between plasma concentration of AZD8055 concentrations and the extent of liver impairment.

    Time frame: During Cycle 1 of the study - blood samples before study treatment and then on Day 1, 3, 10, 17, 24, 30 and then on day 1 of every cycle

  3. Evaluate the change in Phosphorylation levels of certain biomarkers before and after treatment with AZD8055

    Time frame: Blood samples x 3 times on Day 1 of the first cycle

  4. To collect and store DNA for future exploratory research that may influence response to AZD8055

    Time frame: Blood sample on Day 1 or at any other visit during study

    May not be reported in the CSR

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I/II, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Tor Kinase Inhibitor (AZD8055) in Asian Patients With Advanced Stage Hepatocellular Carcinoma (HCC) and With Mild or Moderate Hepatic Impairment

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 22, 2009
Registry last updated
Jul 10, 2012

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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