CancerPhase 1NCT00973076
Study to Assess the Safety and Tolerability of the Tor Kinase Inhibitor AZD8055
A Phase 1 study testing AZD8055 in people with Cancer and Solid Tumors, run by AstraZeneca at 1 site in Japan.
Trial summary
The primary objective is to assess the safety and tolerability of AZD8055 in Japanese patients with advanced solid tumours. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cancer, Solid Tumors, Advanced Solid Malignancies
- 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
- 19 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2009to Dec 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese patients with advanced solid tumors for which suitable effective standard treatment does not exist or is no longer effective
- Relatively good overall health other than cancer
Who cannot join
- Poor bone marrow function (not producing enough blood cells)
- Poor liver or kidney function
- Serious concomitant illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open Label, Single-centre Study to Assess the Safety and Tolerability of the Tor Kinase Inhibitor AZD8055 Administered Orally to Japanese Patients With Advanced Solid Tumours
The primary objective is to assess the safety and tolerability of AZD8055 in Japanese patients with advanced solid tumours.
- Conditions
- Cancer, Solid Tumors, Advanced Solid Malignancies
- Being tested
- AZD8055
- Keywords
- Phase I, cancer, solid tumors, advanced solid malignancies, dose escalation, mTOR Kinase Inhibitor, Japanese
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8055Drug
Tablets, orally administered, twice daily
| Study group | Role | What they receive |
|---|---|---|
| AZD8055 | Experimental | AZD8055 will be administered orally Receives: Drug: AZD8055 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of adverse events, clinical laboratory tests (clinical chemistry, haematology, coagulation, urinalysis), glucose management (s-glucose, s-insulin, haemoglobin A1c [HbA1c]), vital signs (pulse rate, blood pressure, weight and body temperature)
Measured: Laboratory values, vital sign, physical examination every week during Cycle 1 and 2.
Secondary outcomes (2)
To determine the pharmacokinetic profile of AZD8055 following both single and multiple oral dosing in patients with advanced solid tumours
Measured: According to protocol specified schedule, the number of PK samples collected during Cycle 1
To seek preliminary evidence of the anti-tumour activity of AZD8055 in patients with advanced solid malignancies as measured by objective tumour response (according to RECIST criteria)
Measured: Every cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ian Smith, Study director, AstraZenecaTomohide Tamura, Principal investigator, National Cancer Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973076
- Sponsor's protocol ID
- D1600C00003
- Status last verified
- Jun 2011
- First submitted
- 7 Sep 2009
- Last updated
- 15 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Asahina H, Nokihara H, Yamamoto N, Yamada Y, Tamura Y, Honda K, Seki Y, Tanabe Y, Shimada H, Shi X, Tamura T. Safety and tolerability of AZD8055 in Japanese patients with advanced solid tumors; a dose-finding phase I study. Invest New Drugs. 2013 Jun;31(3):677-84. doi: 10.1007/s10637-012-9860-4. Epub 2012 Jul 28.
PubMed 22843211
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Single-centre Study to Assess the Safety and Tolerability of the Tor Kinase Inhibitor AZD8055 Administered Orally to Japanese Patients With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT00973076
- Acronym / sponsor ID
- D1600C00003
- Conditions
- Cancer, Solid Tumors, Advanced Solid Malignancies
- Keywords
- Phase I, cancer, solid tumors, advanced solid malignancies, dose escalation, mTOR Kinase Inhibitor, Japanese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 9 Sep 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 primary objective is to assess the safety and tolerability of AZD8055 in Japanese patients with advanced solid tumours.
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: AZD8055AZD8055 will be administered orally |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Japanese patients with advanced solid tumors for which suitable effective standard treatment does not exist or is no longer effective
- Relatively good overall health other than cancer
Key exclusion criteria (3 listed)
- Poor bone marrow function (not producing enough blood cells)
- Poor liver or kidney function
- Serious concomitant illness
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 |
|---|---|---|
| AZD8055Tablets, orally administered, twice daily | Drug | AZD8055 |
Primary outcome
Assessment of adverse events, clinical laboratory tests (clinical chemistry, haematology, coagulation, urinalysis), glucose management (s-glucose, s-insulin, haemoglobin A1c [HbA1c]), vital signs (pulse rate, blood pressure, weight and body temperature)
Time frame: Laboratory values, vital sign, physical examination every week during Cycle 1 and 2.
2 secondary outcomes
To determine the pharmacokinetic profile of AZD8055 following both single and multiple oral dosing in patients with advanced solid tumours
Time frame: According to protocol specified schedule, the number of PK samples collected during Cycle 1
To seek preliminary evidence of the anti-tumour activity of AZD8055 in patients with advanced solid malignancies as measured by objective tumour response (according to RECIST criteria)
Time frame: Every cycle
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 15 Jun 2011.
- Derived from this study: PubMed 22843211Asahina H, Nokihara H, Yamamoto N, Yamada Y, Tamura Y, Honda K, Seki Y, Tanabe Y, Shimada H, Shi X, Tamura T. Safety and tolerability of AZD8055 in Japanese patients with advanced solid tumors; a dose-finding phase I study. Invest New Drugs. 2013 Jun;31(3):677-84. doi: 10.1007/s10637-012-9860-4. Epub 2012 Jul 28.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Ian Smith study director
AstraZeneca
Tomohide Tamura principal investigator
National Cancer Center Hospital
1 site in 1 country: 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 Solid Tumors, run by AstraZeneca at 1 site in Japan.
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 2 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 15 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
Assessment of adverse events, clinical laboratory tests (clinical chemistry, haematology, coagulation, urinalysis), glucose management (s-glucose, s-insulin, haemoglobin A1c [HbA1c]), vital signs (pulse rate, blood pressure, weight and body temperature) (time frame: Laboratory values, vital sign, physical examination every week during Cycle 1 and 2.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00973076, which also lists 1 linked publication.
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 15 Jun 2011.