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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD5363 | Experimental | Ascending doses of AZD5363 administered orally to patients to define the maximum tolerated dose (MTD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD5363 | Drug | Patients will be given AZD5363 capsules administered orally as a single dose, and then multiple twice-daily dosing following 3 to 7 days washout. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Stockman, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Chūōku | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26351323 | Derived | 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. |
| Label | URL |
|---|---|
| d3610c00004\_protocol\_protocol amendments\_Redacted\_JPOL MP 11APR\_Redacted....pdf | View source |
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| ID | Term |
|---|---|
| C575618 | capivasertib |
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| 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 | 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. | 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 | 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 | 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 | 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 | 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 | PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15. |