Clinical trial NCT00999882: Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of Tor Kinase Inhibitor in Liver Cancer Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Advanced Hepatocellular Carcinoma
Keywords: mTor Kinase Inhibitor
Phase I/II
Dose escalation
Hepatocellular carcinoma (HCC)
Asia
HCC
Safety and pharmacokinetics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-10-22
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety and tolerability (Adverse events, vital signs, ECG, chemistry, haematology, urinalysis, physical examination)
timeFrame: Every week for Cycle 1 and 2, every 2 weeks from cycle 3 onwards, every 4 weeks from cycle 7 onwards
measure: Evaluate the pharmacokinetics of AZD8055 following both single and multiple dosing
timeFrame: Blood samples on 6 occasions during the first Cycle of the study (28 days)
Secondary outcomes:
measure: To make a preliminary assessment of efficacy
timeFrame: Every 4 weeks
measure: To investigate the possible relationship between plasma concentration of AZD8055 concentrations and the extent of liver impairment.
timeFrame: 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
measure: Evaluate the change in Phosphorylation levels of certain biomarkers before and after treatment with AZD8055
timeFrame: Blood samples x 3 times on Day 1 of the first cycle
measure: To collect and store DNA for future exploratory research that may influence response to AZD8055
timeFrame: Blood sample on Day 1 or at any other visit during study
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Seongnam
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: Prince of Wales Hospital, HongKong
name: Brigette Ma
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Ian Smith
role: STUDY_DIRECTOR
References: