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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04493853




Registration number
NCT04493853
Ethics application status
Date submitted
9/07/2020
Date registered
30/07/2020

Titles & IDs
Public title
Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency
Scientific title
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.
Secondary ID [1] 0 0
2020-000346-33
Secondary ID [2] 0 0
D361BC00001
Universal Trial Number (UTN)
Trial acronym
CAPItello-281
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hormone-Sensitive Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Capivasertib
Other interventions - Placebo
Treatment: Drugs - Abiraterone Acetate

Experimental: Capivasertib + Abiraterone - Participants receive capivasertib in combination with abiraterone (prednisone/prednisolone) on a background of ADT.

Placebo comparator: Placebo + Abiraterone - Participants receive placebo in combination with abiraterone (prednisone/prednisolone) on a background of ADT.


Treatment: Drugs: Capivasertib
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.

Other interventions: Placebo
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.

Treatment: Drugs: Abiraterone Acetate
Administered orally as tablets at a dosage of 1000 mg daily. Administered continuously until criteria for discontinuation are met.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiographic Progression-free Survival (rPFS)
Timepoint [1] 0 0
Up to approximately 55 months
Secondary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
Up to approximately 80 months
Secondary outcome [2] 0 0
Time to Start of First Subsequent Therapy or Death (TFST)
Timepoint [2] 0 0
Up to approximately 55 months
Secondary outcome [3] 0 0
Symptomatic Skeletal Event-Free Survival (SSE-FS)
Timepoint [3] 0 0
Up to approximately 80 months
Secondary outcome [4] 0 0
Time to Pain Progression (TTPP)
Timepoint [4] 0 0
Up to approximately 80 months
Secondary outcome [5] 0 0
Time to PSA progression
Timepoint [5] 0 0
Up to approximately 55 months
Secondary outcome [6] 0 0
Time To Castration Resistance (TTCR)
Timepoint [6] 0 0
Up to approximately 80 months
Secondary outcome [7] 0 0
Fatigue intensity, severity and interference domains assessed by the Brief Fatigue Inventory (BFI)
Timepoint [7] 0 0
Up to approximately 80 months
Secondary outcome [8] 0 0
Overall Pain Severity and Pain Interference as assessed by BPI-SF questionnaire
Timepoint [8] 0 0
Up to approximately 80 months
Secondary outcome [9] 0 0
Disease-Related Symptoms and HRQoL using the Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) questionnaire
Timepoint [9] 0 0
Up to approximately 80 months
Secondary outcome [10] 0 0
Progression-Free Survival after next-line treatment (PFS2)
Timepoint [10] 0 0
Up to approximately 80 months
Secondary outcome [11] 0 0
Plasma concentration of capivasertib pre-dose
Timepoint [11] 0 0
Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15
Secondary outcome [12] 0 0
Plasma concentration of capivasertib 1h post-dose
Timepoint [12] 0 0
Cycle 1 Day 1
Secondary outcome [13] 0 0
Plasma concentration of capivasertib 4h post-dose
Timepoint [13] 0 0
Cycle 1 Day 1

Eligibility
Key inclusion criteria
* 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
* 7-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
Minimum age
18 Years
Maximum age
130 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* 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:

i. Absolute neutrophil count < 1.5x 10^9/L ii. Platelet count < 100x 10^9/L iii. Haemoglobin < 9 g/dL (< 5.59 mmol/L) iv. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5x upper limit of normal (ULN) if no demonstrable liver metastases or > 5x ULN in the presence of liver metastases. Elevated alkaline phosphatase (ALP) is not exclusionary if due to the presence of bone metastases and liver function is otherwise considered adequate in the investigator's judgement v. Total bilirubin > 1.5x ULN (participants with confirmed Gilbert's syndrome may be included in the study with a higher value) vi. Creatinine clearance < 50 mL/min (measured or calculated by Cockcroft and Gault equation)
* 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
* 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, metabolic dysfunction, 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.
* Treatment with any of the following:

i. Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment ii. Any investigational agents or study drugs from a previous clinical study within 30 days or 5 half-lives (whichever is longer) of the first dose of study treatment iii. Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks of the first dose of study treatment. A longer washout may be required for drugs with a long half-life (eg, biologics) iv. Strong inhibitors or strong inducers of CYP3A4 within 2 weeks before the start of study treatment (3 weeks for St John's wort). Note that adequate washout or dose reduction may be required for some CYP3A substrates prior to initiating Capivasertib dosing.
* Drugs known to significantly prolong the QT interval and associated with Torsades de Pointes within 5 half-lives of the first dose of study treatment
* Participation in another clinical study with an investigational product administered in the last 30 days or 5 half-lives, whichever is longer.
* History of hypersensitivity to active or inactive excipients of capivasertib, abiraterone, or drugs with a similar chemical structure or class.
* Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
* Any restriction or contraindication based on the local prescribing information that would prohibit the use of abiraterone.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/03/2027
Actual
Sample size
Target
Accrual to date
Final
1012
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Birtinya
Recruitment hospital [2] 0 0
Research Site - Darlinghurst
Recruitment hospital [3] 0 0
Research Site - Kingswood
Recruitment hospital [4] 0 0
Research Site - Orange
Recruitment hospital [5] 0 0
Research Site - South Brisbane
Recruitment postcode(s) [1] 0 0
4575 - Birtinya
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2747 - Kingswood
Recruitment postcode(s) [4] 0 0
2800 - Orange
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment outside Australia
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Country [163] 0 0
Japan
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Thailand
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Thailand
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Thailand
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Muang
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Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04493853