CancerPhase 1NCT00999882
Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of Tor Kinase Inhibitor in Liver Cancer Patients
A Phase 1 study testing AZD8055 in people with Cancer and Advanced Hepatocellular Carcinoma, run by AstraZeneca at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Advanced Hepatocellular Carcinoma
- What is being tested?
- AZD8055
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2009to Dec 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
South Korea2 sites
Research Site
Seongnam-si, Gyeonggi-do
Research Site
Seoul
About this study
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
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.
- Conditions
- Cancer, Advanced Hepatocellular Carcinoma
- Being tested
- AZD8055
- Keywords
- mTor Kinase Inhibitor, Phase I/II, Dose escalation, Hepatocellular carcinoma (HCC), Asia, HCC, Safety and pharmacokinetics
- Medical subject headings
- Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| AZD8055 | Experimental | Dose escalation Receives: Drug: AZD8055 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability (Adverse events, vital signs, ECG, chemistry, haematology, urinalysis, physical examination)
Measured: 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
Measured: Blood samples on 6 occasions during the first Cycle of the study (28 days)
Secondary outcomes (4)
To make a preliminary assessment of efficacy
Measured: Every 4 weeks
To investigate the possible relationship between plasma concentration of AZD8055 concentrations and the extent of liver impairment.
Measured: 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
Measured: 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
May not be reported in the CSR
Measured: Blood sample on Day 1 or at any other visit during study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brigette Ma, Principal investigator, Prince of Wales Hospital, HongKongIan Smith, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999882
- Sponsor's protocol ID
- D1600C00014
- Status last verified
- Jul 2012
- First submitted
- 13 Oct 2009
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00999882
- Acronym / sponsor ID
- D1600C00014
- Conditions
- Cancer, Advanced Hepatocellular Carcinoma
- Keywords
- mTor Kinase Inhibitor, Phase I/II, Dose escalation, Hepatocellular carcinoma (HCC), Asia, HCC, Safety and pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD8055 | Experimental | Drug: AZD8055Dose escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD8055Dose 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. | Drug | AZD8055 |
Primary outcome
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
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)
4 secondary outcomes
To make a preliminary assessment of efficacy
Time frame: Every 4 weeks
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigette Ma principal investigator
Prince of Wales Hospital, HongKong
Ian Smith study director
AstraZeneca
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD8055 in people with Cancer and Advanced Hepatocellular Carcinoma, run by AstraZeneca at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2012.