Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency
CAPItello-281
A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib+Abiraterone Versus Placebo+Abiraterone as Treatment for Patients With DeNovo Metastatic Hormone-Sensitive Prostate Cancer Characterised by PTEN Deficiency.
3 other identifiers
interventional
1,012
31 countries
318
Brief Summary
This study will assess the efficacy and safety of capivasertib plus abiraterone (+prednisone/prednisolone) plus androgen deprivation therapy (ADT) versus placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC whose tumours are characterised by PTEN deficiency. The intention of the study is to demonstrate that in participants with mHSPC, the combination of capivasertib plus abiraterone (+prednisone/prednisolone) plus ADT is superior to placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC characterised by PTEN deficiency with respect to radiographic progression-free survival (rPFS) per 1) Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for soft tissue and/or Prostate Cancer Working Group (PCWG3) for bone as assessed by the investigator 2) death due to any cause.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2020
Longer than P75 for phase_3
318 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
July 9, 2020
CompletedStudy Start
First participant enrolled
July 13, 2020
CompletedFirst Posted
Study publicly available on registry
July 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
ExpectedMay 5, 2026
April 1, 2026
4.2 years
July 9, 2020
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Radiographic Progression-free Survival (rPFS)
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.
Up to approximately 55 months
Secondary Outcomes (13)
Overall survival (OS)
Up to approximately 80 months
Time to Start of First Subsequent Therapy or Death (TFST)
Up to approximately 55 months
Symptomatic Skeletal Event-Free Survival (SSE-FS)
Up to approximately 80 months
Time to Pain Progression (TTPP)
Up to approximately 80 months
Time to PSA progression
Up to approximately 55 months
- +8 more secondary outcomes
Other Outcomes (7)
Incidence and Severity of Adverse Events (AEs)
Up to approximately 80 months
Systolic and diastolic blood pressure
Up to approximately 80 months
Pulse rate (heart rate)
Up to approximately 80 months
- +4 more other outcomes
Study Arms (2)
Capivasertib + Abiraterone
EXPERIMENTALParticipants receive capivasertib in combination with abiraterone (prednisone/prednisolone) on a background of ADT.
Placebo + Abiraterone
PLACEBO COMPARATORParticipants receive placebo in combination with abiraterone (prednisone/prednisolone) on a background of ADT.
Interventions
400 mg (2 tablets) BD given on an intermittent weekly dosing schedule. Patients will be dosed on Days 1 to 4 in each week of a 28-day treatment cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.
matched to capivasertib appearance (2 tablets) BD given on an intermittent weekly dosing schedule. Patients will be dosed on Days 1 to 4 in each week of a 28-day treatment cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.
Administered orally as tablets at a dosage of 1000 mg daily. Administered continuously until criteria for discontinuation are met.
Eligibility Criteria
You may qualify if:
- Asymptomatic or mildly symptomatic, histologically-confirmed de novo hormone-sensitive prostate adenocarcinoma without small-cell tumours diagnosed within 180 days of randomisation
- Consent to provide a FFPE tissue block (preferred) or slides. Tissue from bone metastases is not acceptable
- A valid PTEN IHC result indicating PTEN deficiency (centralized testing)
- Metastatic disease documented prior to randomisation by clear evidence of ≥ 1 bone lesion and/or ≥ 1 soft tissue lesion accurately assessed at baseline and suitable for repeated assessment with CT and/or MRI. PSMA PET identification only will not be eligible
- Candidate for abiraterone and steroid therapy
- Ongoing ADT with GnRH analogue, or LHRH agonists or antagonist, or bilateral orchiectomy (regardless of method) is from 0 days to a max. of 93 days prior to randomisation
- Eastern Cooperative Oncology Group (ECOG)/WHO performance status 0 to 1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
- Able and willing to swallow and retain oral medication
- day Brief Pain Inventory-Short Form (BPI-SF) and Brief Fatigue Inventory(BFI) questionnaires and the analgesic diary during screening completed. Participants must complete a minimum of 4 successful assessments within a 7-day period prior to randomisation.
- Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
- Capable of giving signed informed consent
- Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples
You may not qualify if:
- Prior radical prostatectomy or definitive radiotherapy with therapeutic intent for prostate cancer. Palliative radiotherapy is allowed providing any wide field radiation therapy is completed more than 4 weeks before the start of study treatment
- Major surgery (excluding placement of vascular access, transurethral resection of prostate, bilateral orchiectomy, or internal stents) within 4 weeks of the start of study treatment
- Brain metastases, or spinal cord compression (unless spinal cord compression is asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment)
- Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
- Any of the following cardiac criteria:
- i. Mean resting corrected QT interval (QTc) \> 470 msec obtained from triplicate ECGs ii. History of QT prolongation associated with other medications that required discontinuation of that medication.
- iii. Family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.
- iv. Medical history significant for arrhythmia which is symptomatic or requires treatment, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia.
- v. Any clinically important abnormalities in conduction or morphology of resting ECG (eg, complete left bundle branch block, third-degree heart block) vi. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as hypokalaemia, potential for torsades de pointes, congenital long QT syndrome, or any concomitant medication known to significantly prolong the QT interval vii. Experience of any of the following procedures or conditions in the preceding 3 months: coronary artery bypass graft, angioplasty, myocardial infarction, angina pectoris.
- viii. Congestive heart failure NYHA Grade ≥ 2 ix. Symptomatic hypotension - systolic blood pressure (SBP) \<90 mmHg and/or diastolic blood pressure (DBP) \<50 mmHg x. Uncontrolled hypertension (SBP ≥ 160 mmHg or DBP ≥ 95 mmHg).
- Clinically significant abnormalities of glucose metabolism as defined by any of the following:
- i. Patients with diabetes mellitus type 1 or diabetes mellitus 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 severe or uncontrolled systemic diseases, including active bleeding diatheses, or known active infection including hepatitis B, hepatitis C, and HIV
- unevaluable for both bone and soft tissue progression as defined by meeting both of the following criteria: i. a "superscan" of bone scan, and ii. no soft tissue lesion that can be assessed by RECIST criteria
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (323)
Research Site
Tucson, Arizona, 85723, United States
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Tucson, Arizona, 85741, United States
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La Jolla, California, 92037, United States
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Orange, California, 92868, United States
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San Diego, California, 92123, United States
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Denver, Colorado, 80211, United States
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Lakewood, Colorado, 80215, United States
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Norwich, Connecticut, 06360, United States
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Fort Myers, Florida, 33901-8101, United States
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West Palm Beach, Florida, 33401, United States
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Chicago, Illinois, 60637, United States
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Geneva, Illinois, 60134, United States
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Lisle, Illinois, 60532, United States
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Baltimore, Maryland, 21201, United States
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Detroit, Michigan, 48201, United States
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Grand Rapids, Michigan, 49503, United States
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Troy, Michigan, 48084, United States
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Syracuse, New York, 13210, United States
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The Bronx, New York, 10461, United States
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Asheville, North Carolina, 28805, United States
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Durham, North Carolina, 27710, United States
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Columbus, Ohio, 43210, United States
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Lancaster, Pennsylvania, 17601, United States
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Philadelphia, Pennsylvania, 19111, United States
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Pittsburgh, Pennsylvania, 15232, United States
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Charleston, South Carolina, 29401, United States
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Myrtle Beach, South Carolina, 29572, United States
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Chattanooga, Tennessee, 37404, United States
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Houston, Texas, 77090, United States
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Norfolk, Virginia, 23502, United States
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Roanoke, Virginia, 24014, United States
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Seattle, Washington, 98104, United States
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Madison, Wisconsin, 53792, United States
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Berazategui, B1884BBF, Argentina
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Buenos Aires, 1426, Argentina
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CABA, 1425, Argentina
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CABA, C1012AAR, Argentina
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Ciudad de Buenos Aires, C1120AAT, Argentina
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Ciudad de Buenos Aires, C1280AEB, Argentina
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La Plata, 1900, Argentina
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Mendoza, 5500, Argentina
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Rosario, S2000DEJ, Argentina
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San Salvador de Jujuy, 4600, Argentina
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Birtinya, 4575, Australia
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Darlinghurst, 2010, Australia
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Kingswood, 2747, Australia
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Orange, 2800, Australia
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South Brisbane, 4101, Australia
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Graz, 8036, Austria
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Linz, 4020, Austria
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Salzburg, 5020, Austria
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Anderlecht, 1070, Belgium
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Ghent, 9000, Belgium
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Kortrijk, 8500, Belgium
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Liège, 4000, Belgium
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Belém, 66073-005, Brazil
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Belo Horizonte, 30110-022, Brazil
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Florianópolis, 88020-210, Brazil
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Fortaleza, 60135-237, Brazil
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Jaú, 17210-120, Brazil
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Joinville, 89201-260, Brazil
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Porto Alegre, 90035-000, Brazil
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Porto Alegre, 90050-170, Brazil
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Porto Alegre, 90160-093, Brazil
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Ribeirão Preto, 14051-140, Brazil
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Rio de Janeiro, 20230-130, Brazil
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Santa Maria, 97015-450, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01327-001, Brazil
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Três Lagoas, 79601-001, Brazil
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Pleven, 5804, Bulgaria
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Plovdiv, 4004, Bulgaria
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Plovdiv, 4109, Bulgaria
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Sofia, 1407, Bulgaria
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Sofia, 1527, Bulgaria
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Sofia, 1756, Bulgaria
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Sofia, 1797, Bulgaria
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Varna, 9000, Bulgaria
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Calgary, Alberta, T2N 5G2, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Kelowna, British Columbia, V1Y 5L3, Canada
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Vancouver, British Columbia, V5Z 1H7, Canada
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Brampton, Ontario, L6R 3J7, Canada
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Oshawa, Ontario, L1G 2B9, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, H3T 1E2, Canada
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Santiago, 7500653, Chile
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Santiago, 7500787, Chile
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Santiago, 8420383, Chile
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Temuco, 4781156, Chile
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Viña del Mar, 2540488, Chile
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Beijing, 100034, China
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Beijing, 100036, China
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Beijing, 100050, China
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Beijing, CN-100730, China
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Changchun, 130021, China
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Changsha, 410003, China
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Changsha, 410008, China
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Chengdu, 610000, China
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Chengdu, 610072, China
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Chongqing, 400030, China
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Chongqing, 400038, China
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Fuzhou, 350001, China
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Fuzhou, 350005, China
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Guangzhou, 510060, China
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Guangzhou, 510180, China
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Guangzhou, 510515, China
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Guiyang, 550002, China
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Hangzhou, 310003, China
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Hangzhou, 310014, China
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Hangzhou, 310052, China
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Kunming, 650118, China
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Nanchang, 330006, China
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Nanjing, 2100008, China
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Nanjing, 210009, China
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Nantong, 226361, China
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Ningbo, 315000, China
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Shanghai, 200032, China
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Shanghai, 200080, China
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Shanghai, 200127, China
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Shengyang, 110004, China
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Tianjin, 300211, China
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Wenzhou, CN-325000, China
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Wuhan, 430030, China
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Xi'an, 710061, China
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Yantai, 264000, China
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Zhengzhou, 450000, China
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Zhengzhou, 450008, China
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Brno, 656 91, Czechia
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Hořovice, 268 31, Czechia
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Hradec Králové, 500 05, Czechia
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Prague, 100 34, Czechia
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Prague, 120 00, Czechia
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Prague, 180 81, Czechia
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Besançon, 25030, France
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Bordeaux, 33076, France
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Marseille, 13273, France
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Montpellier, 34298, France
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Nice, 06100, France
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Paris, 75674, France
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Pierre-Bénite, 69495, France
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Quimper, 29107, France
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Rennes, 35033, France
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Strasbourg, 67098, France
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Suresnes, 92151, France
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Villejuif, 94805, France
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Berlin, 10117, Germany
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Duisburg, 47169, Germany
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Hamburg, 20246, Germany
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Herne, 44625, Germany
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Mettmann, 40822, Germany
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Münster, 48149, Germany
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Nuremberg, 90419, Germany
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Nürtingen, 72622, Germany
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Wesel, 46483, Germany
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Hong Kong, 00000, Hong Kong
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Hong Kong, Hong Kong
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Lai Chi Kok, Hong Kong
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Ahmedabad, 380060, India
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Bangalore, 560022, India
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Bangalore, 560027, India
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Delhi, 110085, India
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Faridabad, 121001, India
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Kanpur, 208005, India
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Kolkata, 700160, India
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Madurai, 625107, India
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Manipal, 576104, India
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Meerut, 250001, India
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Mohali, 160055, India
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Nagpur, 440001, India
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New Delhi, 110005, India
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New Delhi, 11029, India
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Thiruvananthapuram, 695 011, India
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Varanasi, 221005, India
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Haifa, 3109601, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 95847, Israel
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Petah Tikva, 4941492, Israel
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Ramat Gan, 52621, Israel
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Ẕerifin, 70300, Israel
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Bunkyō City, 113-8431, Japan
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Chiba, 260-8677, Japan
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Chūōku, 260-8717, Japan
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Fukuoka, 812-8582, Japan
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Hamamatsu, 431-3192, Japan
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Hirakata-shi, 573-1191, Japan
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Hirosaki-shi, 036-8563, Japan
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Isehara-shi, 259-1193, Japan
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Kanazawa, 920-8641, Japan
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Kashihara-shi, 634-8522, Japan
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Kawagoe-shi, 350-8550, Japan
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Kisarazu-shi, 292-8535, 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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Kyoto, 606-8507, Japan
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Miyazaki, 889-1692, Japan
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Morioka, 028-3695, Japan
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Nagano, 381-8551, Japan
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Nagasaki, 852-8501, Japan
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Nagoya, 466-8560, Japan
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Nagoya, 466-8650, Japan
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Natori-shi, 981-1293, Japan
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Osaka, 541-8567, Japan
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Osakasayama-shi, 589-8511, Japan
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Ota Shi, 373-8550, Japan
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Sagamihara-shi, 252-0375, Japan
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Sapporo, 060-8648, Japan
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Shinjuku-ku, 160-8582, Japan
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Toon-shi, 791-0295, Japan
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Tsu, 514-8507, Japan
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Ube-shi, 755-8505, Japan
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Yokohama, 232-0024, Japan
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Yokosuka-shi, 238-8558, Japan
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Yufu-shi, 879-5593, Japan
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Culiacán, 80040, Mexico
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Culiacán, 80230, Mexico
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Guadalajara, 44680, Mexico
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Mexico City, 0 3100, Mexico
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Monterrey, 64460, Mexico
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Monterrey, 64710, Mexico
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Amsterdam, 1066 CX, Netherlands
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Hilversum, 1213 XZ, Netherlands
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Roosendaal, 4708 AE, Netherlands
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The Hague, 2545 AA, Netherlands
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Tilburg, 5042AD, Netherlands
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Utrecht, 3543 AZ, Netherlands
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Callao, CALLAO 02, Peru
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Lima, 0051, Peru
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Lima, LIMA 29, Peru
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Lima, LIMA 31, Peru
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Lima, Lima 32, Peru
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Lima, LIMA 34, Peru
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San Isidro, 27, Peru
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Baguio City, 2600, Philippines
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Cebu City, 6000, Philippines
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Davao City, 8000, Philippines
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Iloilo City, 5000, Philippines
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Quezon City, 1101, Philippines
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Quezon City, 1112, Philippines
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San Juan City, 1500, Philippines
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Bydgoszcz, 85-796, Poland
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Gdansk, 80-214, Poland
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Koszalin, 75-581, Poland
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Lodz, 90-242, Poland
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Olsztyn, 10-228, Poland
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Poznan, 61-731, Poland
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Rzeszów, 35-055, Poland
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Torun, 87-100, Poland
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Warsaw, 02-781, Poland
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Warsaw, 04-073, Poland
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Moscow, 105077, Russia
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Moscow, 117997, Russia
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Moscow, 121205, Russia
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Novisibirsk, 630082, Russia
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Novosibirsk, 630007, Russia
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Saint Petersburg, 190103, Russia
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Saint Petersburg, 191014, Russia
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Yaroslavl, 150054, Russia
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Bratislava, 81102, Slovakia
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Bratislava, 851 05, Slovakia
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Martin, 036 59, Slovakia
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Nitra, 49401, Slovakia
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Prešov, 08001, Slovakia
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Šaľa, 92701, Slovakia
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Trenčín, 911 01, Slovakia
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Cape Town, 7570, South Africa
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Johannesburg, 2013, South Africa
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Johannesburg, 2193, South Africa
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Parow, 7505, South Africa
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Port Elizabeth, 6045, South Africa
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Pretoria, 0084, South Africa
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Daegu, 41404, South Korea
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Goyang-si, 10408, South Korea
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Seongnam-si, 13620, 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, 06351, South Korea
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Seoul, 06591, South Korea
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Badalona (Barcelona), 08916, Spain
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Barcelona, 08041, Spain
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Las Palmas de Gran Canaria, 35016, Spain
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Madrid, 28007, Spain
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Madrid, 28034, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Oviedo, 33011, Spain
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Santander, 39008, Spain
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Seville, 41009, Spain
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Kaohsiung City, 807, Taiwan
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Kaohsiung City, 81362, Taiwan
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Taichung, 404, Taiwan
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Taichung, 43503, Taiwan
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Tainan, 710, Taiwan
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Taipei, 112, Taiwan
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Taipei, 11490, Taiwan
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Taoyuan City, 333, Taiwan
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Bangkok, 10210, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Chiang Mai, 50200, Thailand
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Hat Yai, 90110, Thailand
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Lampang, 52000, Thailand
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Muang, 22000, Thailand
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Ankara, 06010, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Antalya, 07059, Turkey (Türkiye)
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Eskişehir, 26040, Turkey (Türkiye)
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Istanbul, 34098, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Izmir, 35575, Turkey (Türkiye)
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Kayseri, 38039, Turkey (Türkiye)
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Cambridge, CB2 0QQ, United Kingdom
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Guildford, GU2 7XX, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Plymouth, PL6 8DH, United Kingdom
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Sutton, SM2 5PT, United Kingdom
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Whitchurch, CF14 2TL, United Kingdom
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Hanoi, 100000, Vietnam
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Hà Nội, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2020
First Posted
July 30, 2020
Study Start
July 13, 2020
Primary Completion
October 7, 2024
Study Completion (Estimated)
March 31, 2027
Last Updated
May 5, 2026
Record last verified: 2026-04
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/PhRMA 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 de-identified individual patient-level data via secure research environment Vivli.org. A Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. 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 approved.