Advanced Solid MalignancyPhase 1NCT01353781
Open Label Phase 1 Study in Japan for Patient With Advanced Solid Malignancies
A Phase 1 study testing AZD5363 in people with Advanced Solid Malignancy and Advanced Solid Tumor, run by AstraZeneca at 1 site in Japan.
Trial summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of ascending doses of AZD5363 under adaptable dosing schedules in Japanese patients with advanced solid malignancies. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Solid Malignancy, Advanced Solid Tumor
- What is being tested?
- AZD5363
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2011to Jul 2014
- 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
- Aged at least 20 years
- Histological or cytological confirmation of a solid malignant tumour, excluding lymphoma, that is refractory to standard therapies or for which no standard therapies exist
- At least one lesion (measurable and/or non-measurable) that can be accurately assessed according to RECIST
- World Health Organisation (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
- Patients should be willing to remain in hospital until the completion of the first cycle including cycle 0, cycle 1, and cycle 2 Day1 (as cycle 1 Day 21)
Who cannot join
- Clinically significant abnormalities of glucose metabolism as defined by any of the following:
- Diagnosis of diabetes mellitus type I or II (irrespective of management)
- Baseline fasting glucose value of ≥7 mmol/l (126mg/dL)
- Glycosylated haemoglobin (HbA1C) >6.5%
- Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment
- Inadequate bone marrow reserve or organ function
- Any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, or active infection
- With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 Under Adaptable Dosing Schedules in Japanese Patients With Advanced Solid Malignancies
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of ascending doses of AZD5363 under adaptable dosing schedules in Japanese patients with advanced solid malignancies.
- Conditions
- Advanced Solid Malignancy, Advanced Solid Tumor
- Being tested
- AZD5363
- Keywords
- Phase 1, advanced solid tumor, AKT, Ascending, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5363Drug
Patients will be given AZD5363 capsules administered orally as a single dose, and then multiple twice-daily dosing following 3 to 7 days washout.
| Study group | Role | What they receive |
|---|---|---|
| AZD5363 | Experimental | Ascending doses of AZD5363 administered orally to patients to define the maximum tolerated dose (MTD) Receives: Drug: AZD5363 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the safety and tolerability of AZD5363 to define a Recommended Dose (RD) when given orally
To investigate the safety and tolerability of AZD5363 to define a Recommended Dose (RD) when given orally, either as a continuous or an intermittent schedule, for further clinical evaluation when given to Japanese patients with advanced solid malignancies
Measured: All AEs will be collected throughout the study, from informed consent until 30 days after the end of study treatment. The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive
Secondary outcomes (8)
To define the maximum tolerated dose (MTD) if possible or biological effective dose in Japanese patients with advanced solid malignancies.
To define the maximum tolerated dose (MTD) if possible or biological effective dose in Japanese patients with advanced solid malignancies. A dose will be considered non-tolerated and dose escalation will cease if 2 or more of up to 6 evaluable patients experience a DLT at a dose level. Six evaluable patients are required to determine the MTD
Measured: once 2 or more participants experience a DLT a dose level during the study period (within approx 20 months)
To characterise the pharmacokinetics parameters Cmin
To characterise the pharmacokinetics parameters Cmin of AZD5363 following a single administration and after multiple dosing when given orally to Japanese patients with advanced solid malignancies
Measured: PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.
To obtain a preliminary assessment of the anti-tumour activity of AZD5363 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in Japanese patients with advanced solid malignancies
To obtain a preliminary assessment of the anti-tumour activity of AZD5363 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in Japanese patients with advanced solid malignancies.
The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
Measured: Assessed every 3 weeks for initial 2 cycles and every 6 weeks for later cycles for all subjects after start of study treatment until discontinuation of study treatment or withdrawal of consent.
To characterise the pharmacokinetics parameters(Cmax)
To characterise the pharmacokinetics parameters Cmax of AZD5363 following a single administration and after multiple dosing when given orally to Japanese patients with advanced solid malignancies
Measured: PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.
To characterise the pharmacokinetics parameters tmax
To characterise the pharmacokinetics parameters tmax of AZD5363 following a single administration and after multiple dosing when given orally to Japanese patients with advanced solid malignancies
Measured: PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.
To characterise the pharmacokinetics parameters AUC
To characterise the pharmacokinetics parameters AUC factor of AZD5363 following a single administration and after multiple dosing when given orally to Japanese patients with advanced solid malignancies
Measured: PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.
To characterise the pharmacokinetics parameters CL/F
To characterise the pharmacokinetics parameters CL/F factor of AZD5363 following a single administration and after multiple dosing when given orally to Japanese patients with advanced solid malignancies
Measured: PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.
To characterise the pharmacokinetics parameters Vz/F
To characterise the pharmacokinetics parameters Vz/F of AZD5363 following a single administration and after multiple dosing when given orally to Japanese patients with advanced solid malignancies
Measured: PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2014
- Study completionJul 2014
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 Advanced Solid MalignancyStudies 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
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Stockman, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353781
- Sponsor's protocol ID
- D3610C00004
- Status last verified
- Apr 2016
- First submitted
- 11 Apr 2011
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Davies BR, Guan N, Logie A, Crafter C, Hanson L, Jacobs V, James N, Dudley P, Jacques K, Ladd B, D'Cruz CM, Zinda M, Lindemann J, Kodaira M, Tamura K, Jenkins EL. Tumors with AKT1E17K Mutations Are Rational Targets for Single Agent or Combination Therapy with AKT Inhibitors. Mol Cancer Ther. 2015 Nov;14(11):2441-51. doi: 10.1158/1535-7163.MCT-15-0230. Epub 2015 Sep 8.
PubMed 26351323
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 Under Adaptable Dosing Schedules in Japanese Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT01353781
- Acronym / sponsor ID
- D3610C00004
- Conditions
- Advanced Solid Malignancy, Advanced Solid Tumor
- Keywords
- Phase 1, advanced solid tumor, AKT, Ascending, Japanese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 16 May 2011 (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 this study is to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of ascending doses of AZD5363 under adaptable dosing schedules in Japanese patients with advanced solid malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD5363 | Experimental | Drug: AZD5363Ascending doses of AZD5363 administered orally to patients to define the maximum tolerated dose (MTD) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged at least 20 years
- Histological or cytological confirmation of a solid malignant tumour, excluding lymphoma, that is refractory to standard therapies or for which no standard therapies exist
- At least one lesion (measurable and/or non-measurable) that can be accurately assessed according to RECIST
- World Health Organisation (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
- Patients should be willing to remain in hospital until the completion of the first cycle including cycle 0, cycle 1, and cycle 2 Day1 (as cycle 1 Day 21)
Key exclusion criteria (8 listed)
- Clinically significant abnormalities of glucose metabolism as defined by any of the following:
- Diagnosis of diabetes mellitus type I or II (irrespective of management)
- Baseline fasting glucose value of ≥7 mmol/l (126mg/dL)
- Glycosylated haemoglobin (HbA1C) >6.5%
- Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment
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 |
|---|---|---|
| AZD5363Patients will be given AZD5363 capsules administered orally as a single dose, and then multiple twice-daily dosing following 3 to 7 days washout. | Drug | AZD5363 |
Primary outcome
To investigate the safety and tolerability of AZD5363 to define a Recommended Dose (RD) when given orally
Time frame: All AEs will be collected throughout the study, from informed consent until 30 days after the end of study treatment. The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive
To investigate the safety and tolerability of AZD5363 to define a Recommended Dose (RD) when given orally, either as a continuous or an intermittent schedule, for further clinical evaluation when given to Japanese patients with advanced solid malignancies
8 secondary outcomes
To define the maximum tolerated dose (MTD) if possible or biological effective dose in Japanese patients with advanced solid malignancies.
Time frame: once 2 or more participants experience a DLT a dose level during the study period (within approx 20 months)
To characterise the pharmacokinetics parameters Cmin
Time frame: PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.
To obtain a preliminary assessment of the anti-tumour activity of AZD5363 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in Japanese patients with advanced solid malignancies
Time frame: Assessed every 3 weeks for initial 2 cycles and every 6 weeks for later cycles for all subjects after start of study treatment until discontinuation of study treatment or withdrawal of consent.
To characterise the pharmacokinetics parameters(Cmax)
Time frame: PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.
To characterise the pharmacokinetics parameters tmax
Time frame: PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.
To characterise the pharmacokinetics parameters AUC
Time frame: PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.
To characterise the pharmacokinetics parameters CL/F
Time frame: PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.
To characterise the pharmacokinetics parameters Vz/F
Time frame: PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.
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 26 Apr 2016.
- Derived from this study: PubMed 26351323Davies BR, Guan N, Logie A, Crafter C, Hanson L, Jacobs V, James N, Dudley P, Jacques K, Ladd B, D'Cruz CM, Zinda M, Lindemann J, Kodaira M, Tamura K, Jenkins EL. Tumors with AKT1E17K Mutations Are Rational Targets for Single Agent or Combination Therapy with AKT Inhibitors. Mol Cancer Ther. 2015 Nov;14(11):2441-51. doi: 10.1158/1535-7163.MCT-15-0230. Epub 2015 Sep 8.
- d3610c00004\_protocol\_protocol amendments\_Redacted\_JPOL MP 11APR\_Redacted....pdfLink provided by the sponsor.
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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.
Paul Stockman, MD study director
AstraZeneca
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 AZD5363 in people with Advanced Solid Malignancy and Advanced Solid Tumor, 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 5 inclusion and 8 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 26 Apr 2016. 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?
To investigate the safety and tolerability of AZD5363 to define a Recommended Dose (RD) when given orally (time frame: All AEs will be collected throughout the study, from informed consent until 30 days after the end of study treatment. The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive). 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 NCT01353781, 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 26 Apr 2016.