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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer, Advanced Hepatocellular Carcinoma

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Brigette Ma

Investigator Role:

Principal Investigator

Investigator Affiliation:

Prince of Wales Hospital, HongKong

Authority:

Hong Kong: Department of Health

Study ID:

D1600C00014

NCT ID:

NCT00999882

Start Date:

October 2009

Completion Date:

December 2011

Related Keywords:

  • Cancer
  • Advanced Hepatocellular Carcinoma
  • mTor Kinase Inhibitor
  • Phase I/II
  • Dose escalation
  • Hepatocellular carcinoma (HCC)
  • Asia
  • HCC
  • Safety and pharmacokinetics
  • Carcinoma
  • Carcinoma, Hepatocellular

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