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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05348577




Registration number
NCT05348577
Ethics application status
Date submitted
18/03/2022
Date registered
27/04/2022
Date last updated
15/03/2024

Titles & IDs
Public title
Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC)
Scientific title
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)
Secondary ID [1] 0 0
2023-504996-26
Secondary ID [2] 0 0
D361EC00001
Universal Trial Number (UTN)
Trial acronym
CAPItello280
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - capivasertib
Treatment: Drugs - docetaxel
Other interventions - placebo
Treatment: Drugs - docetaxel

Experimental: capivasertib + docetaxel - Participants receive capivasertib in combination with docetaxel and steroids on a background of ADT.

Placebo Comparator: placebo + docetaxel - Participants receive placebo in combination with docetaxel and steroids on a background of ADT.


Treatment: Drugs: capivasertib
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.

Treatment: Drugs: docetaxel
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.

Other interventions: placebo
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.

Treatment: Drugs: docetaxel
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.
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
Overall Survival (OS)
Timepoint [1] 0 0
up to approximately 52 months
Secondary outcome [1] 0 0
Radiographic Progression-free Survival (rPFS)
Timepoint [1] 0 0
up to approximately 40 months
Secondary outcome [2] 0 0
Time to pain progression (TTPP)
Timepoint [2] 0 0
up to approximately 40 months
Secondary outcome [3] 0 0
Time to first Symptomatic Skeletal-Related Event (SSRE)
Timepoint [3] 0 0
up to approximately 52 months
Secondary outcome [4] 0 0
Time to deterioration in urinary symptoms (TTDUS)
Timepoint [4] 0 0
up to approximately 40 months
Secondary outcome [5] 0 0
Time to deterioration in Physical Functioning (TTDPF)
Timepoint [5] 0 0
up to approximately 40 months
Secondary outcome [6] 0 0
Overall Pain Severity and Pain Interference as assessed by BPI-SF questionnaire
Timepoint [6] 0 0
up to approximately 40 months
Secondary outcome [7] 0 0
Plasma concentration of capivasertib derived from a population PK model
Timepoint [7] 0 0
pre dose (up to 90 minutes prior) and post dose (1 hour, 2 hours and 4 hours post dose)

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

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 per
the Cockcroft and Gault formula without the need for chronic dialysis;

- 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.

- Known to have human immunodeficiency virus (HIV) with a CD4+ T-cell count < 350
cells/uL or a history of an acquired immunodeficiency syndrome (AIDS)-defining
opportunistic infection within the past 12 months.

- Known to have active tuberculosis infection (clinical evaluation that may include
clinical history, physical examination and radiographic findings, or tuberculosis
testing in line with local practice).

- Treatment with any of the following:

i. Prior chemotherapy for CRPC. Chemotherapy for metastatic or localized HSPC
(including docetaxel) is allowed provided that chemotherapy was completed = 6months
before randomisation and progression of the prostate cancer occurred = 6months after
the completion of therapy.

ii. Prior exposure to AKT inhibitors or PI3K inhibitors iii. 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 iv. Any other immunotherapy, immunosuppressant
medication (other than corticosteroids) or anticancer agents (except ADT) within 3 weeks of
the first dose of study treatment v. Strong inhibitors or strong inducers of cytochrome
P450 (CYP)3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St
John's wort), vi.Use of any live vaccine administration 30 days prior to the initiation of
study treatment, during, and for at least 90 days after the last dose of the study
treatment

- Drugs known to significantly prolong the QT interval and associated with Torsade de
Pointes within 5 half-lives of the first dose of study treatment

- History of hypersensitivity to active or inactive excipients of capivasertib,
docetaxel, 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 docetaxel

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
25/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/12/2026
Actual
Sample size
Target
790
Accrual to date
Final
Recruitment in Australia
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Research Site - Birtinya
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Research Site - Greenslopes
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Research Site - Kogarah
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Research Site - Miranda
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Research Site - Wahroonga
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4575 - Birtinya
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4120 - Greenslopes
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2217 - Kogarah
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2228 - Miranda
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5000 - North Adelaide
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2800 - Orange
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4020 - Redcliffe
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2076 - Wahroonga
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Turkey
State/province [162] 0 0
Adana
Country [163] 0 0
Turkey
State/province [163] 0 0
Ankara
Country [164] 0 0
Turkey
State/province [164] 0 0
Edirne
Country [165] 0 0
Turkey
State/province [165] 0 0
Istambul
Country [166] 0 0
Turkey
State/province [166] 0 0
Izmir
Country [167] 0 0
Turkey
State/province [167] 0 0
Sahinbey
Country [168] 0 0
Turkey
State/province [168] 0 0
Yüregir
Country [169] 0 0
United Kingdom
State/province [169] 0 0
Bristol
Country [170] 0 0
United Kingdom
State/province [170] 0 0
Cardiff
Country [171] 0 0
United Kingdom
State/province [171] 0 0
Edinburgh
Country [172] 0 0
United Kingdom
State/province [172] 0 0
Glasgow
Country [173] 0 0
United Kingdom
State/province [173] 0 0
Guildford
Country [174] 0 0
United Kingdom
State/province [174] 0 0
Hackensack
Country [175] 0 0
United Kingdom
State/province [175] 0 0
Hampstead
Country [176] 0 0
United Kingdom
State/province [176] 0 0
London
Country [177] 0 0
United Kingdom
State/province [177] 0 0
Manchester
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Southampton
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State/province [179] 0 0
Sutton

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 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 of study participants, when overall survival is defined as the time from
randomization until the date of death due to any cause.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05348577
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/ct2/show/NCT05348577