A Phase 1/2 interventional study of AZD5363 when combined with weekly paclitaxel. and AZD5363 when combined with weekly paclitaxel. in Advanced or Metastatic Breast Cancer and ER+ve Advanced or Metastatic Breast Cancer, sponsored by AstraZeneca. Completed at 41 sites in 11 countries. Open to female participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2023-01-18.
Sponsored by AstraZeneca · Phase 1/2, Interventional, and Treatment
The purpose of this study is to investigate the safety and efficacy of different doses and schedules of AZD5363, when in combination with paclitaxel, in treatment of patients with advanced or metastatic breast cancer. Also to investigate a selected dose and schedule of AZD5363 in combination with paclitaxel vs. paclitaxel in combination with placebo in treatment of patients with estrogen receptor-positive advanced or metastatic breast cancer, including a subgroup who have the phosphoinositide-3-kinase, catalytic, alpha polypeptide (PIK3CA) tumour mutation.
This is a Phase I/II multicentre, study investigating the safety, tolerability and efficacy of a twice-daily oral formulation of AZD5363 when combined with a weekly intravenous paclitaxel infusion in patients with advanced or metastatic breast cancer. Study treatment is given in 28-day cycles, comprising three weeks on-therapy followed by one week off-therapy.
The study will be conducted in two parts:
Part A. Approximately 40 patients will be recruited to this Phase I multiple ascending-dose safety run-in evaluation of each of two intermittent dosing schedules (2 days per week or 4 days per week) of AZD5363 given in combination with weekly paclitaxel. The study population is female patients, 18 years or older, with advanced or metastatic breast cancer.
The purpose of Part A is to assess the comparative safety, tolerability, pharmacokinetics and preliminary efficacy of both schedules to determine one dose and schedule of AZD5363 to take forward to study Part B in combination with weekly paclitaxel.
Part A assessments will be made in dose-escalating cohorts of 3 to 6 patients to determine a recommended dose in each of the schedules. A total of 6 patients must be evaluated at a selected dose level for it to be confirmed as the recommended dose. All dose evaluations and recommendations will be conducted by a Safety Review Committee.
Part A Patients will undergo assessments up to to withdrawal from the study or to discontinuation of study therapy.
Part B. A minimum of 100 patients will be recruited to this Phase II double-blind, placebo-controlled, stratified and randomised evaluation of two treatment regimens: AZD5363 (at a dose selected and schedule from Part A) in combination with weekly paclitaxel vs. weekly paclitaxel plus placebo. The study population is female patients with Estrogen Receptor Positive advanced or metastatic breast cancer; of which approximately 50 will have the phosphoinositide-3-kinase, catalytic, alpha polypeptide (PIK3CA) mutation.
Part B patients will be stratified by PIK3CA tumour mutation status as: tumour mutation positive or tumour mutation not-detected. Under each stratum patients will be randomised to receive either paclitaxel + AZD5363 or paclitaxel + placebo.
The purpose of Part B is to assess relative efficacy of both active and placebo regimens by comparison of: progression-free survival, overall survival, tumour response, safety and tolerability in the overall ER+ve advanced or metastatic breast cancer population, and in a subgroup of these patients with the PIK3CA tumour mutation. Patient safety and therapy tolerability will be monitored by an independent Safety Review Committee throuighout the course of Part B.
Part B patients will be followed for assessment of overall survival, or to withdrawal from the study.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 148 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Part B: any prior chemotherapy for advanced or metastatic breast cancer.
See intervention description below.
Drug: AZD5363 when combined with weekly paclitaxel.
See intervention description below.
Drug: AZD5363 when combined with weekly paclitaxel.
See intervention description below.
Drug: AZD5363when combined with weekly paclitaxel.
See intervention description below.
Drug: A placebo in combination with weekly paclitaxel.
AZD5363: oral capsule, twice daily in a weekly 2 days on-treatment, 5 days-off, schedule. Treatment to begin the day following the first dose of paclitaxel and to continue until treatment withdrawal. Paclitaxel: intravenously once a week. AZD5363 and paclitaxel will be received for 3 consecutive weeks, followed by one week off-therapy in 4-week cycles.
AZD5363: oral capsule, twice daily in a weekly 4 days on-treatment, 3 days-off, schedule. Treatment to begin the day following the first dose of paclitaxel and to continue until treatment withdrawal. Paclitaxel: intravenously once a week. AZD5363 and paclitaxel will be received for 3 consecutive weeks, followed by one week off-therapy in 4-week cycles.
Either a 2/5 or 3/4 intermittent dosing schedule of AZD5363 based on the outcome of Part A. Dosage: oral formulation, twice daily. Treatment to begin the day following the first dose of paclitaxel and to continue until treatment withdrawal. Paclitaxel: intravenously once a week. AZD5363 and paclitaxel will be received for 3 consecutive weeks, followed by one week off-therapy in 4-week cycles.
Either a 2/5 or 3/4 intermittent dosing schedule of placebo matched to AZD5363 based on the outcome of Part A. Dosage: oral formulation, twice daily. Treatment to begin the day following the first dose of paclitaxel and to continue until treatment withdrawal. Paclitaxel: intravenously once a week. placebo and paclitaxel will be received for 3 consecutive weeks, followed by one week off-therapy in 4-week cycles.
Dose-limiting Toxicity (DLT) Events - Part A
An Adverse Event (AE) or laboratory abnormality considered to be related to study drug, that starts at any time during the DLT evaluation period (Cycle 1) and is dose limiting
Time frame: During Part A DLT evaluation period (Cycle 1, up to 28 days)
Progression Free Survival (PFS) - Part B
Time from randomisation to date of objective disease progression or death (by any cause in the absence of progression). Progression defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a \>= 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on the study, and an absolute increase of \>=5mm, or progression of non-target lesions or the appearance of new lesions.
Time frame: From randomisation date to date of objective disease progression or death (by any cause) whichever came first, assessed every 12 wks (median total treatment duration AZD5363=325.5 days; Placebo=245 days)
Change in Tumour Size at 12 Weeks
Percentage change from baseline to week 12 in sum of longest diameters of target lesions as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1). Based on patients with measurable disease who had sufficient data available to either calculate or impute a change at 12 weeks
Time frame: RECIST tumour assessments every 12 weeks
Objective Response Rate (ORR) at Week 12
Percentage of patients who have at least one visit response of Complete Response or Partial Response prior to any evidence of progression at week 12 as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10mm; Objective Response Rate (ORR) = CR + PR
Time frame: RECIST tumour assessments every 12 weeks
Best Objective Response (BOR)
Number of patients, taking their BOR, which is their best objective tumour response based on RECIST measurements throughout the whole study as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10mm.
Time frame: From date of randomisation, assessed every 12 weeks (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).
Overall Objective Response Rate
Percentage of patients, taking their best objective tumour response based on RECIST measurements throughout the whole study as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10mm. Overall Response Rate (ORR) = CR + PR
Time frame: From date of randomisation, assessed every 12 weeks (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).
Number of Subjects Without Progression Disease at Week 12 - Part A
Percentage of patients with a 12 week visit response of CR, PR or SD (as defined by RECIST 1.1) with no evidence of previous progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10mm.
Time frame: up to 12 weeks
Duration of Response (DOR) - Part B
Date of first documentation of response (Complete Response/Partial Response) until the date of disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10mm.. If a subject does not progress following a response, then their DOR will use the PFS censoring time.
Time frame: From date of randomisation, assessed every 12 weeks (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).
Durable Response Rate (DRR) - Part B
Percentage of patients who have a Complete Response (CR) or Partial Response (PR) lasting continuously for at least 24 weeks as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: PR, \>=30% decrease in the sum of the longest diameter of target lesions; CR, disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10mm.
Time frame: From date of randomisation, assessed every 12 weeks (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).
Overall Survival - Part B
The interval between the date of randomisation and the date of patient death due to any cause. All Part B patients were analysed, number of deaths is presented.
Time frame: From date of randomisation, assessed every 12 weeks, up until the time of final statistical analysis. (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).
| Milestone | Part A Schedule 1 560 mg bd | Part A Schedule 1 640 mg bd | Part A Schedule 2 360 mg bd | Part A Schedule 2 400 mg bd | Part A Schedule 2 480 mg bd | Part B AZD5363 | Part B Placebo |
|---|---|---|---|---|---|---|---|
| Started | 12 | 8 | 5 | 7 | 6 | 54 | 56 |
| Received azd5363/placebo treatment | 12 | 8 | 5 | 7 | 6 | 54 | 55 |
| Did not receive azd5363/placebo trt | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Completed | 6 | 4 | 0 | 0 | 0 | 40 | 37 |
| Not completed | 6 | 4 | 5 | 7 | 6 | 14 | 19 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 1 | 2 | 1 |
| Withdrew: Death | 0 | 0 | 1 | 1 | 0 | 11 | 16 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 1 | 0 | 0 | 1 |
| Withdrew: Any reason not specifically recorded | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Progressive disease | 6 | 3 | 4 | 5 | 5 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
An Adverse Event (AE) or laboratory abnormality considered to be related to study drug, that starts at any time during the DLT evaluation period (Cycle 1) and is dose limiting
| participants | Part A Schedule 1 560 mg bd | Part A Schedule 1 640 mg bd | Part A Schedule 2 360 mg bd | Part A Schedule 2 400 mg bd | Part A Schedule 2 480 mg bd | Part B AZD5363 | Part B Placebo |
|---|---|---|---|---|---|---|---|
| Dose-limiting Toxicity (DLT) Events - Part A | 0 | 2 | 0 | 0 | 2 | — | — |
Time from randomisation to date of objective disease progression or death (by any cause in the absence of progression). Progression defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a \>= 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on the study, and an absolute increase of \>=5mm, or progression of non-target lesions or the appearance of new lesions.
| Months | Part A Schedule 1 560 mg bd | Part A Schedule 1 640 mg bd | Part A Schedule 2 360 mg bd | Part A Schedule 2 400 mg bd | Part A Schedule 2 480 mg bd | Part B AZD5363 | Part B Placebo |
|---|---|---|---|---|---|---|---|
| Progression Free Survival (PFS) - Part B | — | — | — | — | — | 10.9 (8.3 to 12.4) | 8.4 (8.2 to 10.8) |
Percentage change from baseline to week 12 in sum of longest diameters of target lesions as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1). Based on patients with measurable disease who had sufficient data available to either calculate or impute a change at 12 weeks
| % change from baseline | Part A Schedule 1 560 mg bd | Part A Schedule 1 640 mg bd | Part A Schedule 2 360 mg bd | Part A Schedule 2 400 mg bd | Part A Schedule 2 480 mg bd | Part B AZD5363 | Part B Placebo |
|---|---|---|---|---|---|---|---|
| Change in Tumour Size at 12 Weeks | -11.0 ± 33.42 | -15.7 ± 13.33 | -19.1 ± 17.73 | -18.3 ± 37.74 | -10.2 ± 24.84 | -34.2 ± 28.91 | -25.4 ± 35.87 |
Percentage of patients who have at least one visit response of Complete Response or Partial Response prior to any evidence of progression at week 12 as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10mm; Objective Response Rate (ORR) = CR + PR
| % of participants | Part A Schedule 1 560 mg bd | Part A Schedule 1 640 mg bd | Part A Schedule 2 360 mg bd | Part A Schedule 2 400 mg bd | Part A Schedule 2 480 mg bd | Part B AZD5363 | Part B Placebo |
|---|---|---|---|---|---|---|---|
| Objective Response Rate (ORR) at Week 12 | 41.7 | 12.5 | 0 | 0 | 0 | 50 | 42.9 |
Number of patients, taking their BOR, which is their best objective tumour response based on RECIST measurements throughout the whole study as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10mm.
| Participants | Part A Schedule 1 560 mg bd | Part A Schedule 1 640 mg bd | Part A Schedule 2 360 mg bd | Part A Schedule 2 400 mg bd | Part A Schedule 2 480 mg bd | Part B AZD5363 | Part B Placebo |
|---|---|---|---|---|---|---|---|
| Complete Response (CR) | 0 | 0 | 0 | 0 | 0 | 3 | 4 |
| Partial Response (PR) | 0 | 2 | 1 | 1 | 0 | 29 | 28 |
| Stable Disease (SD) | 7 | 4 | 3 | 4 | 3 | 14 | 14 |
| Progression | 4 | 1 | 1 | 1 | 2 | 6 | 8 |
| Not Evaluable (NE) | 1 | 1 | 0 | 1 | 1 | 2 | 2 |
Percentage of patients, taking their best objective tumour response based on RECIST measurements throughout the whole study as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10mm. Overall Response Rate (ORR) = CR + PR
| % of participants | Part A Schedule 1 560 mg bd | Part A Schedule 1 640 mg bd | Part A Schedule 2 360 mg bd | Part A Schedule 2 400 mg bd | Part A Schedule 2 480 mg bd | Part B AZD5363 | Part B Placebo |
|---|---|---|---|---|---|---|---|
| Overall Objective Response Rate | 0 | 25 | 20 | 14.3 | 0 | 59.3 | 57.1 |
Percentage of patients with a 12 week visit response of CR, PR or SD (as defined by RECIST 1.1) with no evidence of previous progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10mm.
| Participants | Part A Schedule 1 560 mg bd | Part A Schedule 1 640 mg bd | Part A Schedule 2 360 mg bd | Part A Schedule 2 400 mg bd | Part A Schedule 2 480 mg bd | Part B AZD5363 | Part B Placebo |
|---|---|---|---|---|---|---|---|
| Number of Subjects Without Progression Disease at Week 12 - Part A | 6 | 5 | 3 | 4 | 2 | — | — |
Date of first documentation of response (Complete Response/Partial Response) until the date of disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10mm.. If a subject does not progress following a response, then their DOR will use the PFS censoring time.
| Months | Part A Schedule 1 560 mg bd | Part A Schedule 1 640 mg bd | Part A Schedule 2 360 mg bd | Part A Schedule 2 400 mg bd | Part A Schedule 2 480 mg bd | Part B AZD5363 | Part B Placebo |
|---|---|---|---|---|---|---|---|
| Duration of Response (DOR) - Part B | — | — | — | — | — | 8.3 (6 to 11.3) | 8.2 (5.6 to 10.6) |
Percentage of patients who have a Complete Response (CR) or Partial Response (PR) lasting continuously for at least 24 weeks as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: PR, \>=30% decrease in the sum of the longest diameter of target lesions; CR, disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10mm.
| % of participants | Part A Schedule 1 560 mg bd | Part A Schedule 1 640 mg bd | Part A Schedule 2 360 mg bd | Part A Schedule 2 400 mg bd | Part A Schedule 2 480 mg bd | Part B AZD5363 | Part B Placebo |
|---|---|---|---|---|---|---|---|
| Durable Response Rate (DRR) - Part B | — | — | — | — | — | 48.1 | 37.5 |
The interval between the date of randomisation and the date of patient death due to any cause. All Part B patients were analysed, number of deaths is presented.
| months | Part A Schedule 1 560 mg bd | Part A Schedule 1 640 mg bd | Part A Schedule 2 360 mg bd | Part A Schedule 2 400 mg bd | Part A Schedule 2 480 mg bd | Part B AZD5363 | Part B Placebo |
|---|---|---|---|---|---|---|---|
| Overall Survival - Part B | — | — | — | — | — | 32.8 (21.3 to 32.8) | NA (20.9 to NA) |
Collected over Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part A Schedule 1 560 mg bd | 0/12 (0%) | 3/12 (25%) | 12/12 (100%) |
| Sched 1 - AZD5363 640 mg bd | 0/8 (0%) | 3/8 (37.5%) | 8/8 (100%) |
| Sched 2 - AZD5363 360 mg bd | 1/5 (20%) | 0/5 (0%) | 5/5 (100%) |
| Sched 2 - AZD5363 400 mg bd | 1/7 (14.3%) | 1/7 (14.3%) | 7/7 (100%) |
| Part A Schedule 2 480 mg bd | 0/6 (0%) | 4/6 (66.7%) | 6/6 (100%) |
| Part B AZD5363 | 13/54 (24.1%) | 13/54 (24.1%) | 50/54 (92.6%) |
| Part B Placebo | 15/56 (26.8%) | 8/55 (14.5%) | 48/55 (87.3%) |
| Event | Part A Schedule 1 560 mg bd | Sched 1 - AZD5363 640 mg bd | Sched 2 - AZD5363 360 mg bd | Sched 2 - AZD5363 400 mg bd | Part A Schedule 2 480 mg bd | Part B AZD5363 | Part B Placebo |
|---|---|---|---|---|---|---|---|
| PyrexiaGeneral disorders | 0/12 | 0/8 | 0/5 | 1/7 | 1/6 | 0/54 | 0/55 |
| Drug hypersensitivityImmune system disorders | 0/12 | 0/8 | 0/5 | 0/7 | 1/6 | 0/54 | 0/55 |
| Lower respiratory tract infection bacterialInfections and infestations | 0/12 | 0/8 | 0/5 | 0/7 | 1/6 | 0/54 | 0/55 |
| PneumoniaInfections and infestations | 0/12 | 0/8 | 0/5 | 0/7 | 1/6 | 0/54 | 0/55 |
| Urinary tract infectionInfections and infestations | 0/12 | 0/8 | 0/5 | 0/7 | 1/6 | 0/54 | 0/55 |
| Renal failureRenal and urinary disorders | 0/12 | 0/8 | 0/5 | 0/7 | 1/6 | 0/54 | 0/55 |
| AnaemiaBlood and lymphatic system disorders | 0/12 | 0/8 | 0/5 | 1/7 | 0/6 | 0/54 | 0/55 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/12 | 0/8 | 0/5 | 1/7 | 0/6 | 0/54 | 0/55 |
| NeutropeniaBlood and lymphatic system disorders | 0/12 | 0/8 | 0/5 | 1/7 | 0/6 | 0/54 | 0/55 |
| DiarrhoeaGastrointestinal disorders | 0/12 | 0/8 | 0/5 | 1/7 | 0/6 | 0/54 | 0/55 |
| Event | Part A Schedule 1 560 mg bd | Sched 1 - AZD5363 640 mg bd | Sched 2 - AZD5363 360 mg bd | Sched 2 - AZD5363 400 mg bd | Part A Schedule 2 480 mg bd | Part B AZD5363 | Part B Placebo |
|---|---|---|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 0/12 | 0/8 | 5/5 | 6/7 | 6/6 | 0/54 | 0/55 |
| DiarrhoeaGastrointestinal disorders | 11/12 | 7/8 | 0/5 | 0/7 | 0/6 | 0/54 | 0/55 |
| AstheniaGeneral disorders | 0/12 | 0/8 | 1/5 | 6/7 | 3/6 | 0/54 | 0/55 |
| NauseaGastrointestinal disorders | 0/12 | 0/8 | 3/5 | 2/7 | 5/6 | 0/54 | 0/55 |
| DiarrhoeaGastrointestinal disorders | 0/12 | 0/8 | 0/5 | 0/7 | 0/6 | 41/54 | 15/55 |
| VomitingGastrointestinal disorders | 0/12 | 0/8 | 2/5 | 2/7 | 4/6 | 0/54 | 0/55 |
| NauseaGastrointestinal disorders | 8/12 | 5/8 | 0/5 | 0/7 | 0/6 | 0/54 | 0/55 |
| AstheniaGeneral disorders | 6/12 | 5/8 | 0/5 | 0/7 | 0/6 | 0/54 | 0/55 |
| DizzinessNervous system disorders | 3/12 | 5/8 | 0/5 | 0/7 | 2/6 | 0/54 | 0/55 |
| Upper respiratory tract infectionInfections and infestations | 0/12 | 0/8 | 3/5 | 0/7 | 1/6 | 0/54 | 0/55 |
All patients with data who were included in the full analysis set for Part A and the intention to treat analysis set in Part B'
| Age, Continuous(Years) | Part A Schedule 1 560 mg bd | Part A Schedule 1 640 mg bd | Part A Schedule 2 360 mg bd | Part A Schedule 2 400 mg bd | Part A Schedule 2 480 mg bd | Part B AZD5363 | Part B Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 52.2 ± 9.92 | 58.8 ± 12.78 | 56.6 ± 10.26 | 47.1 ± 9.41 | 49.8 ± 13.12 | 54.3 ± 10.01 | 57.4 ± 11.38 | 58.8 ± 11.24 |
| Age, Customized(Participants) | Part A Schedule 1 560 mg bd | Part A Schedule 1 640 mg bd | Part A Schedule 2 360 mg bd | Part A Schedule 2 400 mg bd | Part A Schedule 2 480 mg bd | Part B AZD5363 | Part B Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| <50 | 5 | 3 | 1 | 4 | 2 | 19 | 16 | 50 |
| >=50 - <65 | 5 | 2 | 3 | 3 | 3 | 24 | 26 | 66 |
| >=65 | 2 | 3 | 1 | 0 | 1 | 11 | 14 | 32 |
| Sex: Female, Male(Participants) | Part A Schedule 1 560 mg bd | Part A Schedule 1 640 mg bd | Part A Schedule 2 360 mg bd | Part A Schedule 2 400 mg bd | Part A Schedule 2 480 mg bd | Part B AZD5363 | Part B Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 12 | 8 | 5 | 7 | 6 | 54 | 56 | 148 |
| Male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Part A Schedule 1 560 mg bd | Part A Schedule 1 640 mg bd | Part A Schedule 2 360 mg bd | Part A Schedule 2 400 mg bd | Part A Schedule 2 480 mg bd | Part B AZD5363 | Part B Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| Asian | 1 | 0 | 0 | 0 | 0 | 12 | 15 | 28 |
| Black Or African American | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| White | 10 | 8 | 5 | 7 | 6 | 24 | 18 | 78 |
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 15 | 16 | 31 |
| Other | 0 | 0 | 0 | 0 | 0 | 3 | 7 | 10 |
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Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
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