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

NCT ID: NCT00999882

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Advanced Hepatocellular Carcinoma

Keywords

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mTor Kinase Inhibitor Phase I/II Dose escalation Hepatocellular carcinoma (HCC) Asia HCC Safety and pharmacokinetics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AZD8055

Dose escalation

Group Type EXPERIMENTAL

AZD8055

Intervention Type 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.

Interventions

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AZD8055

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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brigette Ma

Role: PRINCIPAL_INVESTIGATOR

Prince of Wales Hospital, HongKong

Ian Smith

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Hong Kong, , Hong Kong

Site Status

Research Site

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Research Site

Seoul, , South Korea

Site Status

Countries

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Hong Kong South Korea

Other Identifiers

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D1600C00014

Identifier Type: -

Identifier Source: org_study_id