Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication TRUQAP is a kinase inhibitor indicated: HR positive, HER2 negative locally advanced or metastatic breast cancer • in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alterations as detected by an FDA-authorized test following… FDA label
Also known as AZD5363, [14C]AZD5363 (Capivasertib), Truqap
Capivasertib · 19 trials · 41 indications
* Statistical comparison by survival modelling of time on treatment including competing risks. * Standard curve is derived from placebo + fulvestrant arm of CAPItello-291 trial and corresponds to 17% remaining "on-treatment" at 12 months. * Stratification by eHealth support vs. no eHealth support
* The event DQoL is defined in terms of a 10-point drop of the FACT-G score compared to baseline. * A patient is classified here as "PRO-non-adherent" if she does not use CANKADO on 60 or more of the first 90 days, otherwise as "PRO-adherent".
To assess the efficacy of capi+ful by assessment of TFST (Time to first subsequent treatment) of PIK3CA/AKT1/PTEN-altered subgroup in cohort1
Overall survival is defined as time from randomisation until the date of death due to any cause.
Radiographic Progression-free Survival (rPFS) is defined as time from randomization to radiographic progression as assessed by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) for soft tissue and/or Prostate Cancer Working Group 3 (PCWG3) for bone or death due to any cause
Dose-limiting toxicity as described in the protocol that is not related to disease progression, intercurrent illness or concomitant medications and that, despite optimal therapeutic intervention, meets protocol-defined criteria.
Data will include clinical observations, ECG parameters, clinical chemistry and haematology and vital signs assessed as the number of participants with treatment-related adverse events.
Data will include clinical observations, ECG parameters, clinical chemistry and haematology and vital signs assessed as the number of participants with treatment-related adverse events.
Progression Free Survival (PFS) is defined as time from randomization until progression per RECIST v1.1. as assessed by BICR or death due to any cause in the overall population, the altered population, and the confirmed non-altered population. RECIST related endpoints such as PFS, ORR, DoR, CBR will be collected.
rPFS is defined as the time from randomisation to radiographic progression, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST) for soft tissue and/or Prostate Cancer Working Group 3 (PCWG3) for bone, or death due to any cause for each study arm.
The study aims to evaluate the effectiveness of prophylactic strategies to mitigate diarrhea in patients receiving capivasertib in combination with fulvestrant for hormone receptor-positive (HR+), HER2-negative advanced breast cancer. Toxicities will be graded on the following scale: grade 1 mild, grade 2 moderate, grade 3 severe, grade 4 life threatening/disabling and grade 5 death related to AE.
The study aims to evaluate the effectiveness of prophylactic strategies to mitigate rash in patients receiving capivasertib in combination with fulvestrant for hormone receptor-positive (HR+), HER2-negative advanced breast cancer. Toxicities will be graded on the following scale: grade 1 mild, grade 2 moderate, grade 3 severe, grade 4 life threatening/disabling and grade 5 death related to AE
The primary endpoint CCCA is defined as Ki67 drop to \<2.7% after approximately 10 weeks (will be assessed centrally on the breast tissue submitted to central pathology)
Objective response rate is defined as the proportion of patients achieving either complete response (CR) or partial response (PR) according to the Lugano 2014 Classification for non-Hodgkin lymphoma (NHL) as assessed by blinded independent central review (BICR).
Defined as the highest dose level tested at which 0/6 or 1/6 patients experiences dose limiting toxicities (DLT) during course 1 with at least 2 patients experiencing DLT at the next higher dose.
For patients with leukemia: CR and MRD response after 1 cycle of treatment. This includes determination of CR, CRp, CRi and minimal residual disease (MRD) negativity rate in patients suffering from overt morphological relapse of T-ALL at time of enrolment (morphological disease (M2/M3)), and the MRD negativity rate in those that entered with high-MRD levels but in morphological CR. These results will together be presented as a composite endpoint Overall Response rate (ORR). MRD negativity will be defined as ≤1x10-4 as generated by multi-parameter flow cytometry. For patients with lymphoma: Response in LBL patients is defined as CR, PR, minor response (MR) as defined in International pediatric NHL response criteria. In case of bone-marrow involvement MRD will be taken into account. For patients with lymphoma: Response in LBL patients is defined as CR, PR, minor response (MR) as defined in International pediatric NHL response criteria.
To compare the PK (AUCinf) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function.
To compare the PK (AUClast) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function.
To compare the PK (Cmax) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function.
Area under the plasma concentration-time curve from zero to infinity
Maximum observed plasma (peak) drug concentration
Maximum observed plasma (peak) drug concentration (Cmax) of capivasertib when administered alone under fed and fasted conditions, and in combination with acid reducing agent(s) rabeprazole and famotidine (if required).
Area under plasma concentration time curve from zero to infinity (AUCinf) of capivasertib when administered alone under fed and fasted conditions, and in combination with acid reducing agent(s) rabeprazole and famotidine (if required).
Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) of capivasertib when administered alone under fed and fasted conditions, and in combination with acid reducing agent(s) rabeprazole and famotidine (if required).
AUC0-12 is defined as area under the curve from 0 to 12 hours.
Cmax is defined as maximum plasma concentration
t1/2 is defined as terminal half-life
Rac is defined as accumulation ratio
Assessment of AUCinf of capivasertib.
Assessment of Cmax of capivasertib.
A DLT is defined as an AE that occurs from the first dose of study treatment up to and including the last day of the DLT period (day 1 to day 56 for Part A1) that is assessed as unrelated to the disease, intercurrent illness, or concomitant medications and that, despite optimal therapeutic interventions, meets any of the criteria defined in the protocol.
A DLT is defined as an AE that occurs from the first dose of study treatment up to and including the last day of the DLT period (day 1 to day 28 for Part A2) that is assessed as unrelated to the disease, intercurrent illness, or concomitant medications and that, despite optimal therapeutic interventions, meets any of the criteria defined in the protocol.
To investigate the safety and tolerability of capivasertib when given in combination with novel agents (enzalutamide and abiraterone) to patients with metastatic CRPC.
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 |
|---|---|---|
| Capivasertib | EXPERIMENTAL | 2x400 mg, peroral, for 4 days, followed by 3 days off treatment |
| Cohort 1 | EXPERIMENTAL | Capivasertib+Fulvestrant |
| Cohort 2 | EXPERIMENTAL | Capivasertib+Fulvestrant |
| capivasertib + docetaxel | EXPERIMENTAL | Participants receive capivasertib in combination with docetaxel and steroids on a background of ADT. |
| placebo + docetaxel | PLACEBO_COMPARATOR | Participants receive placebo in combination with docetaxel and steroids on a background of ADT. |
| Capivasertib Plus Palbociclib and Fulvestrant | EXPERIMENTAL | Capivasertib Plus Palbociclib and Fulvestrant (Ph 1b) |
| Capivasertib Plus Ribociclib and Fulvestrant | EXPERIMENTAL | Capivasertib Plus Ribociclib and Fulvestrant (Ph 1b) |
| Capivasertib Plus Abemaciclib and Fulvestrant | EXPERIMENTAL | Capivasertib Plus Abemaciclib and Fulvestrant (Ph 1b) |
| Capivasertib Plus Fulvestrant and Investigator's choice of CDK4/6i (palbociclib or ribociclib) | EXPERIMENTAL | Capivasertib Plus Fulvestrant and Investigator's choice of CDK4/6i (palbociclib or ribociclib) (Ph III) |
| Fulvestrant and Investigator's choice of CDK4/6i (palbociclib or ribociclib) | ACTIVE_COMPARATOR | Fulvestrant and investigator's choice of CDK4/6i (palbociclib or ribociclib) (Ph III) |
| Capivasertib + Abiraterone | EXPERIMENTAL | Participants receive capivasertib in combination with abiraterone (prednisone/prednisolone) on a background of ADT. |
| Placebo + Abiraterone | PLACEBO_COMPARATOR | Participants receive placebo in combination with abiraterone (prednisone/prednisolone) on a background of ADT. |
| Capivasertib + Paclitaxel | EXPERIMENTAL | Paclitaxel: Intravenous infusion. 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle. Capivasertib: Oral tablets. 400 mg of Capivasertib (2 tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle. |
| Placebo + Paclitaxel | PLACEBO_COMPARATOR | Paclitaxel: Intravenous infusion. 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle. Placebo: Oral tablets. 400 mg of Placebo (2 tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle. |
| Rash and diarrhea prophylaxis | EXPERIMENTAL | All participants will receive capivasertib + fulvestrant. Capivasertib will be administered at 400 mg orally, twice daily (BID), on 4-days-on/3-days-off schedule. Fulvestrant will be administered at 500 mg intramuscularly (IM) every 14 days for the first three injections, and every 28 days thereafter. Participants in this arm will take cetirizine 10 mg orally once daily, and loperamide 2 mg orally once daily on capivasertib dosing days, starting on Cycle 1 Day 1 and continued for the first eight weeks (each cycle = 28 days). |
| Rash prophylaxis | EXPERIMENTAL | All participants will receive capivasertib + fulvestrant. Capivasertib will be administered at 400 mg orally, twice daily (BID), on 4-days-on/3-days-off schedule. Fulvestrant will be administered at 500 mg intramuscularly (IM) every 14 days for the first three injections, and every 28 days thereafter. Participants will take cetirizine 10 mg orally once daily, starting on Cycle 1 Day 1 and continued for the first eight weeks (each cycle = 28 days). |
| Arm A | EXPERIMENTAL | Capivasertib (400 mg po twice daily d1-4 followed by 3 days off) for 2 weeks followed by capivasertib (400 mg po twice daily d1-4 followed by 3 days off) and fulvestrant (500 mg i.m. q28d, with an additional 500 mg dose given two weeks after the initial dose) for additional 8 weeks (overall 4 administrations of fulvestrant) |
| Arm B | ACTIVE_COMPARATOR | Fulvestrant (500mg i.m. q28d, with an additional 500 mg dose given two weeks after the core biopsy and the initial dose) for 10 weeks (overall 4 administrations) |
| Capivasertib monotherapy | EXPERIMENTAL | Participants with R/R FL, R/R MZL, and R/R MCL will receive capivasertib orally until progression of disease (PD) or unacceptable toxicity. |
| Capivasertib + Venetoclax + Dexamethasone | EXPERIMENTAL | Sub-study E: Each cycle lasts 28 days. Cycle 1: All patients in cycle 1 will receive 4 blocks of of capivasertib (days D4-7, 11-14, 18-21, 25-28), 28 days of venetoclax (days 1-28), and one block of seven days of dexamethasone (days 1-7). A 1-day venetoclax ramp-up is proposed in this study. Cycle 2 and subsequent cycles: similar to cycle 1. Patients in dose level -1, receive a lower dose of venetoclax. Patients in dose level 2 receive a higher dose of capivasertib. All patients receive age adapted intrathecal chemotherapy. |
| Test: Capivasertib in Moderate hepatic impairment | EXPERIMENTAL | Participants with moderate hepatic impairment will receive a single dose of capivasertib. |
| Control: Capivasertib in Normal hepatic function | EXPERIMENTAL | Participants with normal hepatic function will receive a single dose of capivasertib. |
| Treatment (Midazolam + Capivasertib) | EXPERIMENTAL | Midazolam will be administered on Cycle 1 Day 1 and Cycle 1 Day 8. Capivasertib will be administrated from Cycle 1 Day 2 as an intermittent schedule (4 days on/3 days off) until discontinuation. On Cycle 1 Day 12, Midazolam will be administrated with Capivasertib. |
| Treatment ABC | EXPERIMENTAL | Participants will be randomized to receive oral doses of Treatment A, Treatment B and Treatment C. |
| Treatment ACB | EXPERIMENTAL | Participants will be randomized to receive oral doses of Treatment A, Treatment C and Treatment B. |
| Treatment BAC | EXPERIMENTAL | Participants will be randomized to receive oral doses of Treatment B, Treatment A and Treatment C. |
| Treatment BCA | EXPERIMENTAL | Participants will be randomized to receive oral doses of Treatment B, Treatment C and Treatment A. |
| Treatment CAB | EXPERIMENTAL | Participants will be randomized to receive oral doses of Treatment C, Treatment A and Treatment B. |
| Treatment CBA | EXPERIMENTAL | Participants will be randomized to receive oral doses of Treatment C, Treatment B and Treatment A. |
| Treatment DEF | EXPERIMENTAL | Participants will be randomized to receive oral doses of Treatment D, Treatment E and Treatment F. |
| Treatment DFE | EXPERIMENTAL | Participants will be randomized to receive oral doses of Treatment D, Treatment F and Treatment E. |
| Treatment EDF | EXPERIMENTAL | Participants will be randomized to receive oral doses of Treatment E, Treatment D and Treatment F. |
| Treatment EFD | EXPERIMENTAL | Participants will be randomized to receive oral doses of Treatment E, Treatment F and Treatment D. |
| Treatment FDE | EXPERIMENTAL | Participants will be randomized to receive oral doses of Treatment F, Treatment D and Treatment E. |
| Treatment FED | EXPERIMENTAL | Participants will be randomized to receive oral doses of Treatment F, Treatment E and Treatment D. |
| Capivasertib + Itraconazole | EXPERIMENTAL | Subjects will receive a single oral dose of capivasertib on Day 1 during treatment period 1, itraconazole on Days 3, 4, and 5 during treatment period 2, and single oral dose of capivasertib plus a dose of itraconazole on Day 6, followed by itraconazole alone on Day 7 during treatment period 3. |
| Part A1: Capivasertib + enzalutamide | EXPERIMENTAL | From day 1 to day 28 of this study treatment, patients will continuously enroll on a starting dose of capivasertib in combination with 160 mg enzalutamide. |
| Part A1: Capivasertib dose level 1 + enzalutamide | EXPERIMENTAL | On day 29 of the treatment, patients will escalate the capivasertib dose to dose level+1 along with 160 mg enzalutamide. |
| Part A1: Capivasertib dose level 2 + enzalutamide | EXPERIMENTAL | On day 29 of the treatment, patients will escalate the capivasertib dose to dose level+2 along with 160 mg enzalutamide. |
| Part A2: Capivasertib + abiraterone | EXPERIMENTAL | Patients will continuously enroll on a starting dose of capivasertib in combination with 1000 mg abiraterone. |
| Part B1: Capivasertib + enzalutamide | EXPERIMENTAL | This optional expansion will treat patients at the recommended dose regimen of capivasertib and enzalutamide. |
| Part B2: Capivasertib + abiraterone | EXPERIMENTAL | This optional expansion will treat patients at the recommended dose regimen of capivasertib and abiraterone. |
| 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 |
|---|---|---|
| Capivasertib | DRUG | 2x400 mg, peroral, for 4 days, followed by 3 days off treatment |
| Fulvestrant | DRUG | Fulvestrant IV |
| docetaxel | DRUG | Patients will receive docetaxel in intravenous infusion, 75 mg/m2 BSA, on Day 1 of the 21-day cycles for up to 6 to 10 cycles, according to standard of care practices. |
| placebo | OTHER | matched to capivasertib appearance (2 tablets) BD given orally on an intermittent weekly dosing schedule. Patients will be dosed on Days 2 to 5, 9 to 12, and 16 to 19 in each week of a 21-day treatment cycle. Number of Cycles: until disease progression or unacceptable toxicity develops, death, or if the patient requests to stop the study treatment. |
| Palbociclib | DRUG | Phase Ib: 100 mg/ 125 mg. Once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete 28-day cycle Phase III: Administered once daily for 21 days of 28-day cycle, at the dose of 125 mg. |
| Ribociclib | DRUG | Phase Ib: 200 mg/ 400 mg/ 600 mg. Once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete 28-day cycle Phase III: Administered once daily for 21 days of 28-day cycle, at the dose confirmed in the phase 1b portion. |
| Abemaciclib | DRUG | Phase Ib: 50 mg/ 100 mg/ 150 mg. Twice daily for 28 consecutive days to comprise a complete 28-day cycle |
| Abiraterone Acetate | DRUG | Administered orally as tablets at a dosage of 1000 mg daily. Administered continuously until criteria for discontinuation are met. |
| Paclitaxel | DRUG | 80 mg/m2 concentrate for solution for infusion, 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle. Paclitaxel treatment will be continued for at least 6 cycles unless the patient experiences unacceptable toxicity that is attributed directly to treatment with paclitaxel. |
| Loperamide | DRUG | 2 mg orally once daily on capivasertib dosing days |
| Ceterizine | DRUG | 10 mg orally once a day, starting on Cycle 1 Day 1 and continued for the first eight weeks (each cycle=28 days) |
| Fulvestrant injection | DRUG | find arm B description |
| Venetoclax | DRUG | Oral |
| Dexamethasone | DEVICE | oral/intravenous |
| Intrathecal chemotherapy | DRUG | IT: Methotrexate +/- prednisone/hydrocortisone/cytarabine according to the degree of central nervous involvement |
| Midazolam | DRUG | Single doses of midazolam (syrup, 1 mg) will be given on cycle 1 Days 1, 8, and 12. |
| Rabeprazole | DRUG | Participants will receive twice daily oral doses of rabeprazole for 3 days (Days -3 to -1) and a single dose on the morning of Day 1 for Treatment C. |
| Itraconazole | DRUG | Subjects will be administered itraconazole twice daily on Day 3, followed by once daily doses in the morning for 4 days. |
| Enzalutamide | DRUG | Patients will receive 160 mg oral dose of enzalutamide. |
| Abiraterone | DRUG | Patients will receive 1000 mg oral dose of abiraterone. |
| 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: 1. Females (≥18 years, pre-, peri- or post-menopausal) and males (≥18 years) at the time of signing the informed consent form a. Pre-menopausal (and peri-menopausal, i.e., those that do not meet the criteria for post menopausal defined below) women can be enrolled if amenabl...
Capivasertib is an investigational small molecule AKT inhibitor being developed by AstraZeneca PLC (ticker AZN) for oncology indications. It is being studied in breast cancer, acute lymphoblastic leukemia, advanced solid tumors, and hormone-sensitive prostate cancer. It is a biomarker-selected therapy, meaning trial enrollment is guided by molecular markers rather than an unselected patient population.
Capivasertib targets AKT1, AKT2, and AKT3, the three isoforms of the AKT kinase. It acts as an inhibitor of these targets. By binding AKT isoforms, the drug is designed to interfere with AKT-mediated signaling, a pathway frequently dysregulated in cancers. This mechanism underlies its development across solid tumors and hematologic malignancies.
Capivasertib is being evaluated in HR-positive, HER2-negative advanced and metastatic breast cancer, including patients whose disease has progressed on prior endocrine-based treatment. A Phase III trial (NCT07281833) is studying it alongside standard-of-care endocrine therapy. A separate Phase II trial (NCT07426822) is assessing rash and diarrhea prophylaxis in metastatic HR+/HER2- breast cancer.
Capivasertib is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program, which includes trials in breast cancer, acute lymphoblastic leukemia, advanced solid tumors, and prostate cancer, as well as a pharmacokinetic study in patients with moderate hepatic impairment.
Capivasertib is in clinical development across multiple phases. The program includes Phase I studies in hepatic impairment and pediatric relapsed or refractory hematological malignancies, a Phase II prophylaxis study in breast cancer, and a Phase III study in HR+/HER2- advanced breast cancer. It is investigational and has not been approved by the FDA for these uses.
Capivasertib is being studied in several trials, including NCT07281833, a Phase III trial in HR+/HER2- advanced breast cancer; NCT07426822, a Phase II rash and diarrhea prophylaxis study; NCT07343960, a Phase I pharmacokinetic study in moderate hepatic impairment; and NCT07175415, a Phase I pediatric study in relapsed or refractory hematological malignancies.
Yes, Capivasertib is also known as AZD5363. The name AZD5363 is an earlier development code used by AstraZeneca, and it refers to the same investigational AKT inhibitor. A radiolabeled version, [14C]AZD5363 (Capivasertib), has also been referenced in study documentation.