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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04493853
Ethics application status
Date submitted
9/07/2020
Date registered
30/07/2020
Date last updated
5/05/2021

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
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) - 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.
Timepoint [1] 0 0
Up to approximately 52 months
Secondary outcome [1] 0 0
Overall survival (OS) - Overall survival is the length of time from randomisation until the date of death due to any cause.
Timepoint [1] 0 0
Up to approximately 64 months
Secondary outcome [2] 0 0
Time to Start of First Subsequent Therapy or Death (TFST) - TFST is defined as time from randomisation to the earlier of: the start date of the first subsequent anticancer therapy after discontinuation of randomised treatment (capivasertib/placebo), or death due to any cause.
Timepoint [2] 0 0
Up to approximately 52 months
Secondary outcome [3] 0 0
Symptomatic Skeletal Event-Free Survival (SSE-FS) - SSE-FS is defined as time from randomisation until any of the following: use of radiation therapy to prevent or relieve skeletal symptoms; Occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral); Occurrence of spinal cord compression; Orthopaedic surgical intervention for bone metastasis; Death due to any cause.
Timepoint [3] 0 0
Up to approximately 64 months
Secondary outcome [4] 0 0
Time to Pain Progression (TTPP) - TTPP is defined as the time from randomisation to clinically meaningful pain progression base on a 2-point increase from baseline in the Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("worst pain in 24 hours") score and/or initiation of/increase in opiate analgesic use.
Timepoint [4] 0 0
Up to approximately 64 months
Secondary outcome [5] 0 0
Time to PSA progression - The time from randomisation to PSA progression, as determined by PCWG3 criteria.
Timepoint [5] 0 0
Up to approximately 52 months
Secondary outcome [6] 0 0
Time To Castration Resistance (TTCR) - TTCR is defined as the time from randomisation to the first castration-resistant event (radiographic disease progression, PSA progression, or SSE), whichever occurs first, with castrate levels of testosterone (below 50 ng/dL).
Timepoint [6] 0 0
Up to approximately 64 months
Secondary outcome [7] 0 0
Fatigue intensity, severity and interference domains assessed by the Brief Fatigue Inventory (BFI) - BFI endpoints may include: Time to deterioration in fatigue intensity; Time to deterioration in fatigue interference; Change from baseline in fatigue severity and fatigue interference domain scores.
Timepoint [7] 0 0
Up to approximately 64 months
Secondary outcome [8] 0 0
Overall Pain Severity and Pain Interference as assessed by BPI-SF questionnaire - BPI-SF: Change from baseline in pain severity and pain interference domain scores.
Timepoint [8] 0 0
Up to approximately 64 months
Secondary outcome [9] 0 0
Disease-Related Symptoms and HRQoL using the Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) questionnaire - FACT-P endpoints may include: Time to deterioration in FACT-P scores; Change from baseline in FACT-P scores.
Timepoint [9] 0 0
Up to approximately 64 months
Secondary outcome [10] 0 0
Progression-Free Survival after next-line treatment (PFS2) - PFS2 is defined as time from randomisation until progression on next-line treatment, as clinical progression, PSA progression, or radiographic progression determined by RECIST version 1.1 (soft tissue) and/or PCWG3 criteria (bone), as assessed by the investigator, or death due to any cause.
Timepoint [10] 0 0
Up to approximately 64 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 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 metastatic
hormone-sensitive prostate adenocarcinoma without small-cell tumours

- 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 3 months 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

- Agreement to remain abstinent (refrain from heterosexual intercourse) or use
contraceptive measures, and agreement to refrain from donating sperm
Minimum age
18 Years
Maximum age
130 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Radiotherapy with a wide field of radiation within 4 weeks before the start of study
treatment (capivasertib/placebo)

- 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 3 consecutive
ECGs ii. Any clinically important abnormalities in rhythm, conduction or morphology of
resting ECG (eg, complete left bundle branch block, third-degree heart block) 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.
Clinically significant heart disease as evidenced by myocardial infarction, or
arterial thrombotic events in the past 6 months, severe or unstable angina, or NYHA or
Class II to IV heart failure or cardiac ejection fraction measurement of < 50% v.
Experience of any of the following procedures or conditions in the preceding 6 months:
coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction,
angina pectoris, congestive heart failure NYHA Grade = 2 vi. Uncontrolled hypotension
- systolic blood pressure (SBP) <90 mmHg and/or diastolic blood pressure (DBP) <50
mmHg vii. Cardiac ejection fraction outside institutional range of normal or <50%
(whichever is higher) as measured by echocardiogram (or multiple-gated acquisition
[MUGA] scan if an echocardiogram cannot be performed or is inconclusive) viii.
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 109/L ii. Platelet count < 100x 109/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 > 1.5x ULN concurrent with
creatinine clearance < 50 mL/min (measured or calculated by Cockcroft and Gault
equation); confirmation of creatinine clearance is only required when creatinine is >
1.5x ULN

- 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

- Known additional malignancy that has had progression or has required active treatment
in the last 3 years. Exceptions include basal cell carcinoma of the skin, and squamous
cell carcinoma of the skin that has undergone potentially curative therapy

- 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. Potent inhibitors or inducers of CYP3A4 within 2 weeks before the start
of study treatment (3 weeks for St John's wort), or sensitive substrates of CYP3A4,
CYP2C9 and/or CYP2D6 with a narrow therapeutic window within 1 week before the start
of study treatment

- Drugs known to prolong the QT interval within 5 half-lives of the first dose of study
treatment

- History of hypersensitivity to active or inactive excipients of capivasertib,
abiraterone, or drugs with a similar chemical structure or class

- 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Birtinya
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Research Site - Darlinghurst
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Research Site - Kingswood
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Research Site - Orange
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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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Ho Chi Minh City

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

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT04493853
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
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04493853