NCT00999882

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 cancer

Timeline
Completed

Started Oct 2009

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2009

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 22, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

2.2 years

First QC Date

October 13, 2009

Last Update Submit

July 9, 2012

Conditions

CancerAdvanced Hepatocellular Carcinoma

Keywords

mTor Kinase InhibitorPhase I/IIDose escalationHepatocellular carcinoma (HCC)AsiaHCCSafety and pharmacokinetics

Outcome Measures

Primary Outcomes (2)

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

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

  • Evaluate the pharmacokinetics of AZD8055 following both single and multiple dosing

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

Secondary Outcomes (4)

  • To make a preliminary assessment of efficacy

    Every 4 weeks

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

    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

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

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

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

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

Study Arms (1)

AZD8055

EXPERIMENTAL

Dose escalation

Drug: AZD8055

Interventions

AZD8055DRUG

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.

AZD8055

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Hong Kong, Hong Kong

Location

Research Site

Seongnam-si, Gyeonggi-do, South Korea

Location

Research Site

Seoul, South Korea

Location

MeSH Terms

Conditions

NeoplasmsCarcinoma, Hepatocellular

Interventions

(5-(2,4-bis((3S)-3-methylmorpholin-4-yl)pyrido(2,3-d)pyrimidin-7-yl)-2-methoxyphenyl)methanol

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Brigette Ma

    Prince of Wales Hospital, HongKong

    PRINCIPAL INVESTIGATOR

  • Ian Smith

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2009

First Posted

October 22, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

KR(2)HK(1)