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Also known as Capivasertib, capivasertib
AZD5363 · 3 trials · 19 indications
The actual sampling times were used in the pharmacokinetics (PK) parameter calculations and PK parameters were derived using standard non-compartmental methods. Following the twice daily dosing in Cycle 1 at Day 4 and 11 for both the formulation switch and food effect investigations, the following PK parameters have been determined: Maximum plasma concentration at steady state (Css max), time to Css,max (tss max), minimum plasma concentration at steady state (Css min), area under the plasma concentration-time curve from zero to the end of the dosing interval (AUCss) and apparent clearance (CLss/F). Css max, tss max were determined by inspection of the concentration-time profiles. AUCss was calculated using the linear up / log down trapezoidal rule. CLss/F was determined from the ratio of dose/AUCss. Ratio of Css,max for Day 4 to Day 11 have been derived.
The actual sampling times were used in the parameter calculations and PK parameters were derived using standard non-compartmental methods. Following the twice daily dosing in Cycle 1 at Day 4 and 11 for both the formulation switch and food effect investigations, the following PK parameters have been determined: Css max, tss max, Css min, area under the plasma concentration-time curve from zero to the end of the dosing interval (AUCss) and CLss/F. Css max, tss max were determined by inspection of the concentration-time profiles. AUCss was calculated using the linear up / log down trapezoidal rule. CLss/F was determined from the ratio of dose/AUCss. Ratio of AUCss for Day 4 to Day 11 have been derived.
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
| Arm | Type | Description |
|---|---|---|
| Part A: Formulation Switch | EXPERIMENTAL | AZD5363 tablet twice daily followed by AZD5363 capsule twice daily on an intermittent regimen (4 days on, 3 days off). |
| Part B: Food effect | EXPERIMENTAL | AZD5363 tablet twice daily on an intermittent regimen (4 days on, 3 days off) with/without food on one occasion |
| AZD5363 | EXPERIMENTAL | Ascending doses of AZD5363 administered orally to patients to define the maximum tolerated dose (MTD) |
| Part A and B Schedule 1, Continuous dosing | EXPERIMENTAL | Part A: Ascending doses of AZD5363 administered orally, every day to define the maximum tolerated dose. Part B: Dose expansion phase, at the defined maximum tolerated dose or recommended dose from Part A. |
| Parts A,B,C,D Schedule 2, Intermittent dosing | EXPERIMENTAL | Part A: Ascending doses of AZD5363 administered orally, twice daily, on a 7-day repeating regimen (4 days on, 3 days off and 2 days on, 5 days off), to define the maximum tolerated dose. Part B: Dose expansion phase, at the defined maximum tolerated dose or recommended dose from Part A (4 days on, 3 days off and 2 days on, 5 days off). Part C and D: AZD5363 orally, twice daily on an intermittent regimen (4 days on, 3 days off). |
| Parts A and B Schedule 3, Intermittent dosing. | EXPERIMENTAL | Part A: Ascending doses of AZD5363 administered orally, twice daily, on an alternative weekly regimen. Initiation of Schedule 3 is dependant on emerging clinical data. Part B: Dose expansion phase, at the defined maximum tolerated dose or recommended dose from Part A |
| Parts E and F, Intermittent dosing with Fulvestrant | EXPERIMENTAL | Oral AZD5363 twice daily, 4 days on treatment, 3 days off treatment to cessation of therapy combined with background therapy of fulvestrant at its licensed dose of 500mg intramuscularly on days 1,15,29 and once monthly thereafter to cessation of therapy. |
| Name | Type | Description |
|---|---|---|
| AZD5363 | DRUG | Oral AZD5363 twice daily, 4 days on 3 days off: tablet formulation for one week, followed by two weeks with capsule formulation. |
Inclusion Criteria: - * Aged at least 18 years * The presence of a solid, malignant tumour, excluding lymphoma, that is resistance to standard therapies or for which no standard therapies exist * The presence of at least one lesion that can be accurately assessed at baseline by Computerised Tomogra...
AZD5363, also known as capivasertib, is an investigational small molecule being studied for the treatment of metastatic HR+/HER2- breast cancer, advanced solid malignancies, triple negative breast neoplasms, and lobular breast cancer. It is also being evaluated in healthy volunteers to assess drug interactions and absorption for potential use in metastatic breast and prostate cancer patients.
AZD5363 targets the AKT signaling pathway, which is involved in cell growth and survival. By inhibiting this pathway, the drug aims to block cancer cell proliferation. This mechanism is being explored in combination with fulvestrant for breast cancer treatment.
AZD5363 is developed by AstraZeneca PLC, a global biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is being investigated in clinical trials for multiple oncology indications.
AZD5363 is in Phase 1 clinical development, with early-stage trials completed in healthy volunteers. Additional Phase 2 and Phase 3 studies are ongoing or planned to evaluate its efficacy in breast cancer patients, though the drug remains investigational and not yet approved.
AZD5363 is being studied in several clinical trials, including NCT04712396 and NCT04944771, which are completed Phase 1 studies in healthy volunteers. NCT06607757 is a recruiting Phase 2 trial in lobular breast cancer, and NCT06764186 is an active Phase 3 trial in advanced breast cancer.
Yes, AZD5363 is the same as capivasertib. The drug is referred to by both names in clinical research and medical literature. It is being developed by AstraZeneca for the treatment of various cancers, including breast cancer.