Solid TumorsPhase 1NCT00731263
A Study of Tor Kinase Inhibitor in Advanced Tumors
A Phase 1 study testing AZD8055 in people with Solid Tumors, run by AstraZeneca at 4 sites in 3 countries.
Trial summary
The purpose of the study is to assess the safety, tolerability and pharmacokinetics of AZD8055 and determine the maximum tolerated dose to take into phase II trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- 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
- 64 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Jul 2008to Nov 2010
- 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
- Histological or cytological confirmation of an advanced solid malignant tumour (or lymphoma Part A only)
- Cancer which is refractory to standard therapies or for which no standard therapy exists, patients with measurable or non-measurable disease (according to RECIST criteria) can be recruited to Part A
- Evidence of post-menopausal status or negative urine/serum pregnancy test for pre-menopausal female patients
Who cannot join
- Patients with severe laboratory abnormalities for haematology, liver or renal function. Also treatment with any haemopoietic growth factors are not allowed within two weeks from first dose of study drug.
- Patients with abnormal fasting glucose, have type I or II Diabetes or have uncontrolled blood fats and cholesterol
- Patients with a history of neurological disease, peripheral or central neuropathy, brain metastases or family history of myopathy are excluded
- Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Research Site
Houston, Texas
Research Site
New York, New York, 10065
About this study
Official title: A Phase I/II, Open-Label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Tor Kinase Inhibitor AZD8055 Administered Orally to Patients With Advanced Solid Tumours.
The purpose of the study is to assess the safety, tolerability and pharmacokinetics of AZD8055 and determine the maximum tolerated dose to take into phase II trials.
- Conditions
- Solid Tumors
- Being tested
- AZD8055
- Keywords
- Cancer, Advance solid tumours, Dose Escalation, Preliminary efficacy, AZD8055, Tor kinase inhibitor, Oral administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8055Drug
Oral solution or tablet, single dose on Day 1 Part A, twice daily ascending dosing from day 8 onwards (until maximum tolerated dose is reached), cycles of 28 days treatment.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The study will start with AZD8055 formulated in a liquid solution prior to the tablet formulation becoming available. The tablet formulation will be introduced in Part A at the beginning of a new cohort at an appropriate dose, no higher than the dose of the liquid formulation in the last completed evaluated cohort. Oral solution or tablet, single dose on Day 1 Part A, twice daily ascending dosing from day 8 onwards (until maximum tolerated dose is reached), cycles of 28 days treatment. Receives: Drug: AZD8055 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of AZD8055
Measured: Assessed at all visits
Secondary outcomes (2)
To identify early signals of anti-tumour activity
Measured: Visits 1, 5, and 9 and 11
To identify early signals of anti-tumor activity
Measured: Visits 1, 5, 9 and 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof Stan Kaye, Principal investigator, Royal Marsden Hospital, Sutton, Surrey, England, SM2 5PTDr Carol Aghajanian, Principal investigator, Memorial Sloan-Kettering Cancer Centre, 1275 York Avenue, New York, NY 10065, USADr Aung Naing, Principal investigator, MD Anderson Cancer Centre, 1515 Holcombe Blvd, Houston, Texas, USAProfessor Eric Raymond, Principal investigator, Hôpital Beaujon, 100, Boulevard du Général Leclerc, 92118 Clichy Cedex, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731263
- Sponsor's protocol ID
- D1600C00001
- Other IDs
- 2008-002606-19, 2008
- Status last verified
- Jul 2012
- First submitted
- 6 Aug 2008
- Last updated
- 11 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-Label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Tor Kinase Inhibitor AZD8055 Administered Orally to Patients With Advanced Solid Tumours.
- ClinicalTrials.gov ID
- NCT00731263
- Acronym / sponsor ID
- D1600C00001
- Conditions
- Solid Tumors
- Keywords
- Cancer, Advance solid tumours, Dose Escalation, Preliminary efficacy, AZD8055, Tor kinase inhibitor, Oral administration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 8 Aug 2008 (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 purpose of the study is to assess the safety, tolerability and pharmacokinetics of AZD8055 and determine the maximum tolerated dose to take into phase II trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD8055The study will start with AZD8055 formulated in a liquid solution prior to the tablet formulation becoming available. The tablet formulation will be introduced in Part A at the beginning of a new cohort at an appropriate dose, no higher than the dose of the liquid formulation in the last completed evaluated cohort. Oral solution or tablet, single dose on Day 1 Part A, twice daily ascending dosing from day 8 onwards (until maximum tolerated dose is reached), cycles of 28 days treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histological or cytological confirmation of an advanced solid malignant tumour (or lymphoma Part A only)
- Cancer which is refractory to standard therapies or for which no standard therapy exists, patients with measurable or non-measurable disease (according to RECIST criteria) can be recruited to Part A
- Evidence of post-menopausal status or negative urine/serum pregnancy test for pre-menopausal female patients
Key exclusion criteria (4 listed)
- Patients with severe laboratory abnormalities for haematology, liver or renal function. Also treatment with any haemopoietic growth factors are not allowed within two weeks from first dose of study drug.
- Patients with abnormal fasting glucose, have type I or II Diabetes or have uncontrolled blood fats and cholesterol
- Patients with a history of neurological disease, peripheral or central neuropathy, brain metastases or family history of myopathy are excluded
- Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions
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 |
|---|---|---|
| AZD8055Oral solution or tablet, single dose on Day 1 Part A, twice daily ascending dosing from day 8 onwards (until maximum tolerated dose is reached), cycles of 28 days treatment. | Drug | 1 |
Primary outcome
Safety and tolerability of AZD8055
Time frame: Assessed at all visits
2 secondary outcomes
To identify early signals of anti-tumour activity
Time frame: Visits 1, 5, and 9 and 11
To identify early signals of anti-tumor activity
Time frame: Visits 1, 5, 9 and 13
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 11 Jul 2012.
Related trials for Solid Tumors
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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
Prof Stan Kaye principal investigator
Royal Marsden Hospital, Sutton, Surrey, England, SM2 5PT
Dr Carol Aghajanian principal investigator
Memorial Sloan-Kettering Cancer Centre, 1275 York Avenue, New York, NY 10065, USA
Dr Aung Naing principal investigator
MD Anderson Cancer Centre, 1515 Holcombe Blvd, Houston, Texas, USA
4 sites in 3 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 Solid Tumors, run by AstraZeneca at 4 sites in 3 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 4 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 11 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 4 sites in United States, France, United Kingdom. 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 of AZD8055 (time frame: Assessed at all visits). 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 11 Jul 2012.