Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC)
CAPItello280
A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Docetaxel Versus Placebo + Docetaxel as Treatment for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
3 other identifiers
interventional
1,035
22 countries
217
Brief Summary
This study will assess the efficacy and safety of capivasertib plus docetaxel versus placebo plus docetaxel in participants with metastatic castration resistant prostate cancer (mCRPC), all participants will receive the docetaxel with steroid therapy and receive androgen deprivation therapy. The intention of the study is to demonstrate that the combination of capivasertib plus docetaxel is superior to placebo plus docetaxel with respect to the overall survival and/or the radiographic progression free survival of study participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 prostate-cancer
Started Mar 2022
217 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2022
CompletedStudy Start
First participant enrolled
March 25, 2022
CompletedFirst Posted
Study publicly available on registry
April 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 4, 2026
CompletedJanuary 27, 2025
January 1, 2025
3.9 years
March 18, 2022
January 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall Survival (OS) in the overall population
Overall survival is defined as time from randomisation until the date of death due to any cause.
up to approximately 46 months
Radiographic Progression-free Survival (rPFS) in the overall population
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
up to approximately 37 months
Secondary Outcomes (10)
Overall Survival (OS) in patients with mCRPC and PTEN-proficient tumours (IHC)
up to approximately 46 months
Overall Survival (OS) in patients with mCRPC and PTEN-deficient tumours (IHC).
up to approximately 46 months
Radiographic Progression-free Survival (rPFS) in patients with mCRPC and PTEN-proficient tumours (IHC)
up to approximately 37 months
Radiographic Progression-free Survival (rPFS) in patients with mCRPC and PTEN-deficient tumours (IHC)
up to approximately 37 months
Time to pain progression (TTPP) in the overall population
up to approximately 37 months
- +5 more secondary outcomes
Other Outcomes (5)
The number of participants with adverse events in the overall population
Up to approximately 46 months
Systolic and diastolic blood pressure
Up to approximately 46 months
Pulse rate (heart rate)
Up to approximately 46 months
- +2 more other outcomes
Study Arms (2)
capivasertib + docetaxel
EXPERIMENTALParticipants receive capivasertib in combination with docetaxel and steroids on a background of ADT.
placebo + docetaxel
PLACEBO COMPARATORParticipants receive placebo in combination with docetaxel and steroids on a background of ADT.
Interventions
320 mg (2 tablets) BD given 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.
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.
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.
Eligibility Criteria
You may qualify if:
- Histologically-confirmed prostate adenocarcinoma without predominant neuroendocrine or small cell cancers
- Metastatic disease documented prior to randomisation by clear evidence of ≥ 1 bone lesion (defined as 1 lesion with positive uptake on bone scan) and/or ≥ 1 soft tissue lesion (measurable or non-measurable)
- Patient must have been previously treated with a next generation hormonal agent (NHA), ie, abiraterone, enzalutamide, apalutamide or darolutamide, for prostate cancer for at least 3 months and shown evidence of disease progression (radiological or via PSA assessment) while receiving the NHA
- Evidence of mCRPC with progression of disease despite androgen deprivation therapy (ADT)
- Serum testosterone level ≤ 50 ng/dL
- Candidate for docetaxel and steroid therapy
- Ongoing ADT with LHRH agonist, LHRH antagonist, or bilateral orchiectomy
- Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO) performance status 0 to 1 and anticipated minimum life expectancy of 12 weeks
- Confirmation that archival formalin-fixed paraffin-embedded (FFPE) tumour tissue sample which meets the minimum pathology and sample requirements is available to send to the central laboratory
- Able and willing to swallow and retain oral medication
- Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
You may not qualify if:
- Radiotherapy with a wide field of radiation within 4 weeks before start of study treatment
- Major surgery (excl. placement of vascular access, transurethral resection of prostate, bilateral orchiectomy, internal stents) within 4 weeks of start of study treatment
- Brain metastases,or spinal cord compression (unless spinal cord compression is asymptomatic and stable and not requiring steroids for at least 4 weeks prior to start of study treatment)
- Any of the following cardiac criteria:
- i. Mean resting corrected QT interval (QTc) \>470 msec from 3 consecutive ECGs ii. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG iii. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age,or any concomitant medication known to prolong the QT interval iv. Experience of any of the following procedures or conditions in the preceding 3 months: coronary artery bypass graft, vascular stent, myocardial infarction, unstable angina pectoris, congestive heart failure NYHA Grade ≥2 v. Symptomatic hypotension - systolic blood pressure \<90 mmHg and/or diastolic blood pressure \<50 mmHg vi. haemodinamic instability
- Clinically significant abnormalities of glucose metabolism as defined by any of the following:
- i. Patients with diabetes mellitus (DM) type 1 or DM type 2 requiring insulin treatment ii. HbA1c ≥8.0% (63.9 mmol/mol)
- Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
- As judged by the investigator, any evidence of diseases (including severe or uncontrolled systemic diseases, uncontrolled hypertension, history of interstitial pneumonia / pneumonitis or interstitial lung disease, renal transplant and active bleeding diseases), which, in the investigator's opinion, makes it undesirable for the patient to participate in the study or that would jeopardise compliance with the protocol.
- Refractory nausea and vomiting, malabsorption syndrome, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection, or other condition that would preclude adequate absorption of capivasertib
- Any other disease, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent. Evidence of dementia, altered mental status, or any psychiatric condition that would prohibit understanding or rendering of informed consent.
- Previous allogeneic bone marrow transplant or solid organ transplant
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease.
- Persistent toxicities (CTCAE Grade ≥2) caused by previous anticancer therapy, excluding alopecia. Patients with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in the opinion of the investigator may be included (eg, hearing loss)
- Known to have active hepatitis infection.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (217)
Research Site
Yuma, Arizona, 85364, United States
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Beverly Hills, California, 90211, United States
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Cerritos, California, 90703, United States
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Fresno, California, 93701, United States
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Los Angeles, California, 90095, United States
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Sacramento, California, 95817, United States
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San Francisco, California, 94115, United States
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Santa Barbara, California, 93105, United States
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Santa Monica, California, 90404, United States
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Santa Rosa, California, 95403, United States
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Aurora, Colorado, 80045, United States
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Lakewood, Colorado, 80228, United States
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Littleton, Colorado, 80120, United States
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Baltimore, Maryland, 21201, United States
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Baltimore, Maryland, 21287, United States
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Minneapolis, Minnesota, 55404, United States
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Minneapolis, Minnesota, 55416, United States
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Hackensack, New Jersey, 07601, United States
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Albany, New York, 12208, United States
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The Bronx, New York, 10461, United States
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White Plains, New York, 10601, United States
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Toledo, Ohio, 43623, United States
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Portland, Oregon, 97223, United States
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Bala-Cynwyd, Pennsylvania, 19004-1017, United States
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Philadelphia, Pennsylvania, 19107, United States
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Philadelphia, Pennsylvania, 19111, United States
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Greenville, South Carolina, 29605, United States
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Watertown, South Dakota, 57201, United States
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Chattanooga, Tennessee, 37404, United States
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Nashville, Tennessee, 37203, United States
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Austin, Texas, 78731, United States
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Dallas, Texas, 75235, United States
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Houston, Texas, 77096, United States
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Kingwood, Texas, 77339, United States
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San Antonio, Texas, 78217, United States
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Chesapeake, Virginia, 23320, United States
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Seattle, Washington, 98109, United States
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Birtinya, 4575, Australia
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Greenslopes, 4120, Australia
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Kogarah, 2217, Australia
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North Adelaide, 5000, Australia
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Orange, 2800, Australia
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Redcliffe, 4020, Australia
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Wahroonga, 2076, Australia
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Brasschaat, 2930, Belgium
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Ghent, 9000, Belgium
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Liège, 4000, Belgium
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Cachoeiro de Itapemirim, 29308-014, Brazil
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Ijuí, 98700-000, Brazil
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Itajaí, 88301-220, Brazil
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Joinville, 89201-470, Brazil
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Porto Alegre, 90020-090, Brazil
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Porto Alegre, 90035-903, Brazil
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Porto Alegre, 90110-270, Brazil
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Porto Alegre, 90160-093, Brazil
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Recife, 50040-000, Brazil
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Rio de Janeiro, 22281-100, Brazil
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Rio de Janeiro, 22793-080, Brazil
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Salvador, 41253-190, Brazil
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Salvador, 41820-021, Brazil
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Santa Maria, 97015-450, Brazil
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São José Do Rio Preto - SP, 15090-000, Brazil
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São Paulo, 01221-020, Brazil
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São Paulo, 01509-900, Brazil
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São Paulo, 04014-002, Brazil
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Três Lagoas, 79601-001, Brazil
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Halifax, Nova Scotia, B3H 2Y9, Canada
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Oshawa, Ontario, L1G 2B9, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Toronto, M4N 3M5, Canada
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Santiago, 7500713, Chile
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Santiago, 7500918, Chile
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Santiago, 7650568, Chile
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Viña del Mar, 2520000, Chile
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Beijing, 100021, China
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Beijing, 100034, China
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Beijing, 100050, China
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Changsha, 410008, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chengdu, 610072, China
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Chongqing, 400038, China
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Guangzhou, 510180, China
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Hangzhou, 310000, China
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Hangzhou, 310003, China
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Harbin, 150040, China
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Jiaxing, 314001, China
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Nanchang, 330019, China
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Nanjing, 210008, China
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Nantong, 226361, China
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Ningbo, 315010, China
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Shanghai, 200032, China
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Shanghai, 200040, China
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Shenyang, 110042, China
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Tianjin, 300052, China
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Wuhan, 430030, China
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Wuhan, 430079, China
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Yantai, 264000, China
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Zhengzhou, 450008, China
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Hořovice, 268 01, Czechia
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Hradec Králové, 500 05, Czechia
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Pardubice, 532 03, Czechia
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Prague, 10034, Czechia
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Prague, 14059, Czechia
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Prague, 150 06, Czechia
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Bordeaux, 33076, France
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Brest, 29609, France
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Clermont-Ferrand, 63011, France
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Créteil, 94010, France
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Montpellier, 34298, France
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Paris, 75014, France
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Paris, 75020, France
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Rouen, 76031, France
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Saint-Herblain, 44805, France
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Saint-Mandé, 94160, France
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Strasbourg, 67000, France
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Strasbourg, 67033, France
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Vandœuvre-lès-Nancy, 54000, France
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Villejuif, 94805, France
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Athens, 115 22, Greece
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Athens, 155 62, Greece
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Chaïdári, 124 62, Greece
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Marousi, 151 23, Greece
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Pátrai, 26504, Greece
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Piraeus, 185 47, Greece
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Budapest, 1097, Hungary
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Budapest, 1122, Hungary
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Budapest, 1125, Hungary
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Budapest, 1145, Hungary
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Kecskemét, 6000, Hungary
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Nyíregyháza, 4400, Hungary
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Szeged, 6725, Hungary
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Szolnok, 5000, Hungary
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Bikaner, 334003, India
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Meerut, 250001, India
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Mohali, 160055, India
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New Delhi, 110085, India
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Be’er Ya‘aqov, 70300, Israel
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Haifa, 3109601, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 44281, Israel
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Petah Tikva, 4941492, Israel
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Ramat Gan, 52621, Israel
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Tel Aviv, 6423906, Israel
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Chiba, 260-8717, Japan
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Hirakata-shi, 573-1191, Japan
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Hirosaki-shi, 036-8563, Japan
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Kanazawa, 920-8641, Japan
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Kashihara-shi, 634-8522, Japan
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Kita-gun, 761-0793, Japan
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Kobe, 650-0047, Japan
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Kumamoto, 860-0008, Japan
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Miyazaki, 889-1692, Japan
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Nagano, 381-8551, Japan
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Nagoya, 466-8560, Japan
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Nakano, 164-0001, Japan
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Osaka, 541-8567, Japan
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Osakasayama-shi, 589-8511, Japan
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Sagamihara-shi, 252-0375, Japan
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Sapporo, 003-0804, Japan
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Tsu, 514-8507, Japan
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Wakayama, 641-8510, Japan
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Yokohama, 232-0024, Japan
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Aguascalientes, 20116, Mexico
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Culiacán, 80230, Mexico
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Guadalajara, 44260, Mexico
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Guadalajara, 44680, Mexico
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Mexico City, 03840, Mexico
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México, 04700, Mexico
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Oaxaca City, 68000, Mexico
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Zapopan, 45116, Mexico
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Hoofddorp, 2134 TM, Netherlands
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The Hague, 2545 CH, Netherlands
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Nowa Sól, 67-106, Poland
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Opole, 45-061, Poland
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Wieliszew, 05-135, Poland
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Bukgu, 41404, South Korea
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Busan, 602-739, South Korea
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Goyang-si, 10408, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06591, South Korea
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Seoul, 6273, South Korea
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Barcelona, 08003, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Barcelona, ?08041, Spain
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Córdoba, 14004, Spain
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Lugo, 27003, Spain
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Madrid, 28034, Spain
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Madrid, 28040, Spain
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Málaga, 29010, Spain
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Sabadell, 08208, Spain
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Seville, 41013, Spain
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Kaohsiung City, 81362, Taiwan
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Taichung, 40447, Taiwan
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Tainan, 704, Taiwan
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Tainan, 710, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 11259, Taiwan
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Adana, 01060, Turkey (Türkiye)
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Edirne, 22030, Turkey (Türkiye)
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Izmir, 35575, Turkey (Türkiye)
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Şahinbey, 27310, Turkey (Türkiye)
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Yüreğir, 01240, Turkey (Türkiye)
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Edinburgh, EH4 2XU, United Kingdom
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Glasgow, G12 0YN, United Kingdom
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Guildford, United Kingdom
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Hackensack, 07601-1963, United Kingdom
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London, SE1 9RT, United Kingdom
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London, SW7 3RP, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Southampton, SO16 6YD, United Kingdom
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Sutton, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The study is double-blinded, neither the patients nor the investigator will know what study intervention was assigned. Capivasertib and placebo film-coated tablets will be identical in appearance and presented in the same packaging to ensure blinding of the capivasertib. All personnel involved with the statistical analysis of the study will remain blinded until database lock and CSP deviations have been identified.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2022
First Posted
April 27, 2022
Study Start
March 25, 2022
Primary Completion
March 4, 2026
Study Completion
March 4, 2026
Last Updated
January 27, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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.