Prostate CancerPhase 1NCT04087174
A Multi-centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of Capivasertib (AZD5363) in Combination With Novel Agents in Patients With Metastatic Prostate Cancer
A Phase 1 study testing Capivasertib, Enzalutamide and Abiraterone in people with Prostate Cancer, run by AstraZeneca at 6 sites in 2 countries.
Trial summary
This is a Phase Ib, open-label, multi-centre study to determine the safety, tolerability and pharmacokinetics (PK) of capivasertib when given in combination with novel agents (enzalutamide or abiraterone) to inform the selection of capivasertib dose regimens for each combination for further clinical evaluation when… Read more about this study
- Who is it for?
- Ages 18 to 130 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Capivasertib, Enzalutamide and Abiraterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 5 Aug 2019to 22 Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol prior to any mandatory study-specific procedures, sampling, and analyses.
- Males aged 18 years and older at the time of signing the ICF.
- Patients with documented evidence of metastatic CRPC who have had at least one line of systemic therapy for metastatic CRPC (either chemotherapy or an novel hormonal agents [NHA]) or for whom no alternative approved therapy is available.
- World Health Organization (WHO) performance status 0 to 2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks, as assessed at day 1.
- Patients must be able 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.
- Sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
- Patients should use barrier contraception (ie, condoms) from the time of screening until 16 weeks after discontinuation of study treatment. It is not known whether the preclinical changes seen in the male animal reproductive organs, after treatment with capivasertib, will be fully reversible or will permanently affect the ability to produce healthy sperm following treatment. Therefore, if patients wish to father children they should be advised to arrange for collection of sperm samples prior to the start of study treatment.
Who cannot join
- Previous enrolment in the present study.
- Prior enzalutamide therapy in the last 8 weeks.
- Treatment with any of the following:
- Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment.
- Any investigational agents or study drugs from a previous clinical study within 30 days of the first dose of study treatment.
- Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anti-cancer agents within 3 weeks of the first dose of study treatment, except hormonal therapy with luteinising hormone-releasing hormone (LHRH) analogues for medical castration in patients with prostate cancer, which are permitted.
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- Potent inhibitors or inducers or substrates of CYP3A4 within 2 weeks before the first dose 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 prior to the first dose of study treatment.
- Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment.
- Radiotherapy with a wide field of radiation within 4 weeks of the first dose of study treatment.
- Clinically significant abnormalities of glucose metabolism as defined by any of the following:
- Diabetes mellitus Type I or Type II requiring insulin treatment.
- HbA1c ≥8.0% (63.9 mmol/mol).
- Spinal cord compression or brain metastases unless 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.
- As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required.
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) >470 milliseconds obtained from 3 consecutive ECGs.
- Any clinically important abnormalities in rhythm, conduction, or morphology of a resting ECG (eg, complete left bundle branch block, 3rd degree heart block).
- 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.
- Clinically significant heart disease as evidenced by myocardial infarction or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association NYHA Class II to IV heart failure or cardiac ejection fraction measurement of <50%.
- 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 ≥2.
- Uncontrolled hypotension defined as - systolic BP <90 mmHg and/or diastolic BP<50 mmHg.
- Uncontrolled hypertension defined as - systolic BP >160 mmHg and/or diastolic BP ≥95 mmHg.
- Cardiac ejection fraction outside institutional range of normal or <50% (whichever is higher) as measured by echocardiogram (or multi gated acquisition scan (MUGA), if an echocardiogram cannot be performed or is inconclusive).
- With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Event (CTCAE) grade 1 at the time of starting study treatment.
- Absolute neutrophil count <1.5×10^9/L.
- Platelets <100×10^9/L.
- Haemoglobin <9 g/dL (<5.59 mmol/L). (Note: any blood transfusion must have been >14 days prior to the determination of a haemoglobin ≥9 g/dL [≥5.59 mmol/L]).
- Aspartate aminotransferase (AST) >2.5 times the ULN if no demonstrable liver metastases or >5 times ULN in the presence of liver metastases. Total bilirubin >1.5 times ULN (*patients with confirmed Gilbert's syndrome may be included in the study). Elevated alkaline phosphatase (ALP) is not exclusionary if due to the presence of bone metastasis and liver function is otherwise considered adequate in the investigator's judgement.
- Creatinine >1.5 times 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 >1.5 times ULN.
- Refractory nausea and vomiting, malabsorption syndrome, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection 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 contraindicates 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.
- History of hypersensitivity to active or inactive excipients of capivasertib or drugs with a similar chemical structure or class to capivasertib.
- Judgement 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.
- 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 immunodeficiency syndrome.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Abiraterone-specific exclusion criteria: Any restriction or contraindication based on the currently applicable approved abiraterone label that would prohibit the use of abiraterone.
- Enzalutamide-specific exclusion criteria: Any restriction or contraindication based on the currently applicable approved enzalutamide label that would prohibit the use of enzalutamide.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Research Site
Gettysburg, Pennsylvania, 17325
Research Site
Indianapolis, Indiana, 46202
Research Site
Myrtle Beach, South Carolina, 29572
Research Site
Omaha, Nebraska, 68114
Research Site
White Plains, New York, 10601
About this study
Official title: A Phase I, Open-label, Multi-centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of Capivasertib (AZD5363) in Combination With Novel Agents in Patients With Metastatic Castration Resistant Prostate Cancer
This is a Phase Ib, open-label, multi-centre study to determine the safety, tolerability and pharmacokinetics (PK) of capivasertib when given in combination with novel agents (enzalutamide or abiraterone) to inform the selection of capivasertib dose regimens for each combination for further clinical evaluation when given to patients with metastatic castration resistant prostate cancer (CRPC). The study design allows an exploration of different doses with intensive safety monitoring to ensure the safety of the patients.
Read the detailed description
The study will be conducted on multiple centers (≤10) in USA and Spain. The study design allows an exploration of different doses with intensive safety monitoring to ensure the safety of the patients.
The two planned combination treatments during Part A of this study are:
Part A1: Capivasertib and enzalutamide Part A2: Capivasertib and abiraterone Part B will include any optional dose expansion cohorts based on Safety Review Committee (SRC) review of data from Part A of this study.
The study will include up to approximately 87 evaluable patients, divided among the 4 study parts as follows:
Part A1: Up to approximately 36 patients (up to four dose levels with up to approximately 9 patients per dose level).
Part B1: Up to approximately 12 patients. Part A2: Up to approximately 27 patients (up to three dose levels with up to approximately 9 patients per dose level). Part B2: Up to approximately 12 patients.
- Conditions
- Prostate Cancer
- Being tested
- Capivasertib, Enzalutamide, Abiraterone
- Keywords
- Metastatic, Castration Resistant, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapivasertibDrug
Also called AZD5363
Patients will receive multiple oral dose of capivasertib.
EnzalutamideDrug
Patients will receive 160 mg oral dose of enzalutamide.
AbirateroneDrug
Patients will receive 1000 mg oral dose of abiraterone.
| Study group | Role | What they receive |
|---|---|---|
| Part A1: Capivasertib + enzalutamide | Experimental | From day 1 to day 28 of this study treatment, patients will continuously enroll on a starting dose of capivasertib in combination with 160 mg enzalutamide. Receives: Drug: Capivasertib; Drug: Enzalutamide |
| Part A1: Capivasertib dose level 1 + enzalutamide | Experimental | On day 29 of the treatment, patients will escalate the capivasertib dose to dose level+1 along with 160 mg enzalutamide. Receives: Drug: Capivasertib; Drug: Enzalutamide |
| Part A1: Capivasertib dose level 2 + enzalutamide | Experimental | On day 29 of the treatment, patients will escalate the capivasertib dose to dose level+2 along with 160 mg enzalutamide. Receives: Drug: Capivasertib; Drug: Enzalutamide |
| Part A2: Capivasertib + abiraterone | Experimental | Patients will continuously enroll on a starting dose of capivasertib in combination with 1000 mg abiraterone. Receives: Drug: Capivasertib; Drug: Abiraterone |
| Part B1: Capivasertib + enzalutamide | Experimental | This optional expansion will treat patients at the recommended dose regimen of capivasertib and enzalutamide. Receives: Drug: Capivasertib; Drug: Enzalutamide |
| Part B2: Capivasertib + abiraterone | Experimental | This optional expansion will treat patients at the recommended dose regimen of capivasertib and abiraterone. Receives: Drug: Capivasertib; Drug: Abiraterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with dose limiting toxicity (DLT) for Part A1
A DLT is defined as an AE that occurs from the first dose of study treatment up to and including the last day of the DLT period (day 1 to day 56 for Part A1) that is assessed as unrelated to the disease, intercurrent illness, or concomitant medications and that, despite optimal therapeutic interventions, meets any of the criteria defined in the protocol.
Measured: Day 1 to day 56 for Part A1
Number of patients with DLT for Part A2
A DLT is defined as an AE that occurs from the first dose of study treatment up to and including the last day of the DLT period (day 1 to day 28 for Part A2) that is assessed as unrelated to the disease, intercurrent illness, or concomitant medications and that, despite optimal therapeutic interventions, meets any of the criteria defined in the protocol.
Measured: Day 1 to day 28 for Part A2
Number of patients with adverse events
To investigate the safety and tolerability of capivasertib when given in combination with novel agents (enzalutamide and abiraterone) to patients with metastatic CRPC.
Measured: For each treatment combination, from screening (Day -28 to -1) either for up to 1.5 years or up to 30 days follow-up period after discontinuation
Secondary outcomes (6)
Area under curve (AUC) for capivasertib to characterize pharmacokinetics (PK) for each treatment combination
To characterise the PK of capivasertib when given in combination with novel agents.
Measured: For capivasertib and enzalutamide combination, full sampling on day 25 and on day 53; for capivasertib and abiraterone combination, full sampling on day 25.
Maximum plasma concentration (Cmax) for capivasertib to characterize PK for each treatment combination
To characterise the PK of capivasertib when given in combination with novel agents.
Measured: For capivasertib and enzalutamide combination, full sampling on day 25 and on day 53; for capivasertib and abiraterone combination, full sampling on day 25.
Soft tissue objective response rate (ORR) and radiological ORR for efficacy analyses of capivasertib for each treatment combination
To determine the preliminary signs of activity of capivasertib in combination with novel agents in this patient population.
Measured: From screening (-28 Day) to every 8 weeks after cycle 1 day 1 for the first 24 weeks and every 12 weeks thereafter up to 1.5 years for each treatment combination
Duration of response (DoR) for efficacy analyses of capivasertib for each treatment combination
To determine the preliminary signs of activity of capivasertib in combination with novel agents in this patient population.
Measured: From screening (-28 Day) to every 8 weeks after cycle 1 day 1 for the first 24 weeks and every 12 weeks thereafter up to 1.5 years for each treatment combination
Percentage change in tumour size for efficacy analyses of capivasertib for each treatment combination
To determine the preliminary signs of activity of capivasertib in combination with novel agents in this patient population.
Measured: From screening (-28 Day) to every 8 weeks after cycle 1 day 1 for the first 24 weeks and every 12 weeks thereafter up to 1.5 years for each treatment combination
Radiographic progression free survival (rPFS) for efficacy analyses of capivasertib for each treatment combination
To determine the preliminary signs of activity of capivasertib in combination with novel agents in this patient population.
Measured: From screening (-28 Day) to every 8 weeks after cycle 1 day 1 for the first 24 weeks and every 12 weeks thereafter up to 1.5 years for each treatment combination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start5 Aug 2019
- Primary completion22 Jun 2021
- Study completion22 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study will include up to approximately 87 evaluable patients, divided among the 4 study parts.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087174
- Sponsor's protocol ID
- D3618C00002
- Status last verified
- Jul 2022
- First submitted
- 17 Jul 2019
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Shore N, Mellado B, Shah S, Hauke R, Costin D, Adra N, Cullberg M, Teruel CF, Morris T. A Phase I Study of Capivasertib in Combination With Abiraterone Acetate in Patients With Metastatic Castration-Resistant Prostate Cancer. Clin Genitourin Cancer. 2023 Apr;21(2):278-285. doi: 10.1016/j.clgc.2022.11.017. Epub 2022 Nov 26.
PubMed 36572571
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Multi-centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of Capivasertib (AZD5363) in Combination With Novel Agents in Patients With Metastatic Castration Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT04087174
- Acronym / sponsor ID
- D3618C00002
- Conditions
- Prostate Cancer
- Keywords
- Metastatic, Castration Resistant, Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase Ib, open-label, multi-centre study to determine the safety, tolerability and pharmacokinetics (PK) of capivasertib when given in combination with novel agents (enzalutamide or abiraterone) to inform the selection of capivasertib dose regimens for each combination for further clinical evaluation when given to patients with metastatic castration resistant prostate cancer (CRPC). The study design allows an exploration of different doses with intensive safety monitoring to ensure the safety of the patients.
Detailed description
The study will be conducted on multiple centers (≤10) in USA and Spain. The study design allows an exploration of different doses with intensive safety monitoring to ensure the safety of the patients.
The two planned combination treatments during Part A of this study are:
Part A1: Capivasertib and enzalutamide Part A2: Capivasertib and abiraterone Part B will include any optional dose expansion cohorts based on Safety Review Committee (SRC) review of data from Part A of this study.
The study will include up to approximately 87 evaluable patients, divided among the 4 study parts as follows:
Part A1: Up to approximately 36 patients (up to four dose levels with up to approximately 9 patients per dose level).
Part B1: Up to approximately 12 patients. Part A2: Up to approximately 27 patients (up to three dose levels with up to approximately 9 patients per dose level). Part B2: Up to approximately 12 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- The study will include up to approximately 87 evaluable patients, divided among the 4 study parts.
| Arm | Type | Receives |
|---|---|---|
| Part A1: Capivasertib + enzalutamide | Experimental | Drug: Capivasertib, Drug: EnzalutamideFrom day 1 to day 28 of this study treatment, patients will continuously enroll on a starting dose of capivasertib in combination with 160 mg enzalutamide. |
| Part A1: Capivasertib dose level 1 + enzalutamide | Experimental | Drug: Capivasertib, Drug: EnzalutamideOn day 29 of the treatment, patients will escalate the capivasertib dose to dose level+1 along with 160 mg enzalutamide. |
| Part A1: Capivasertib dose level 2 + enzalutamide | Experimental | Drug: Capivasertib, Drug: EnzalutamideOn day 29 of the treatment, patients will escalate the capivasertib dose to dose level+2 along with 160 mg enzalutamide. |
| Part A2: Capivasertib + abiraterone | Experimental | Drug: Capivasertib, Drug: AbirateronePatients will continuously enroll on a starting dose of capivasertib in combination with 1000 mg abiraterone. |
| Part B1: Capivasertib + enzalutamide | Experimental | Drug: Capivasertib, Drug: EnzalutamideThis optional expansion will treat patients at the recommended dose regimen of capivasertib and enzalutamide. |
| Part B2: Capivasertib + abiraterone | Experimental | Drug: Capivasertib, Drug: AbirateroneThis optional expansion will treat patients at the recommended dose regimen of capivasertib and abiraterone. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol prior to any mandatory study-specific procedures, sampling, and analyses.
- Males aged 18 years and older at the time of signing the ICF.
- Patients with documented evidence of metastatic CRPC who have had at least one line of systemic therapy for metastatic CRPC (either chemotherapy or an novel hormonal agents [NHA]) or for whom no alternative approved therapy is available.
- World Health Organization (WHO) performance status 0 to 2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks, as assessed at day 1.
- Patients must be able to swallow and retain oral medication.
Key exclusion criteria (40 listed)
- Previous enrolment in the present study.
- Prior enzalutamide therapy in the last 8 weeks.
- Treatment with any of the following:
- Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment.
- Radiotherapy with a wide field of radiation within 4 weeks of the first dose of study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapivasertibAlso: AZD5363Patients will receive multiple oral dose of capivasertib. | Drug | Part A1: Capivasertib + enzalutamide, Part A1: Capivasertib dose level 1 + enzalutamide, Part A1: Capivasertib dose level 2 + enzalutamide, Part A2: Capivasertib + abiraterone, Part B1: Capivasertib + enzalutamide, Part B2: Capivasertib + abiraterone |
| EnzalutamidePatients will receive 160 mg oral dose of enzalutamide. | Drug | Part A1: Capivasertib + enzalutamide, Part A1: Capivasertib dose level 1 + enzalutamide, Part A1: Capivasertib dose level 2 + enzalutamide, Part B1: Capivasertib + enzalutamide |
| AbirateronePatients will receive 1000 mg oral dose of abiraterone. | Drug | Part A2: Capivasertib + abiraterone, Part B2: Capivasertib + abiraterone |
Primary outcome
Number of patients with dose limiting toxicity (DLT) for Part A1
Time frame: Day 1 to day 56 for Part A1
A DLT is defined as an AE that occurs from the first dose of study treatment up to and including the last day of the DLT period (day 1 to day 56 for Part A1) that is assessed as unrelated to the disease, intercurrent illness, or concomitant medications and that, despite optimal therapeutic interventions, meets any of the criteria defined in the protocol.
Number of patients with DLT for Part A2
Time frame: Day 1 to day 28 for Part A2
A DLT is defined as an AE that occurs from the first dose of study treatment up to and including the last day of the DLT period (day 1 to day 28 for Part A2) that is assessed as unrelated to the disease, intercurrent illness, or concomitant medications and that, despite optimal therapeutic interventions, meets any of the criteria defined in the protocol.
Number of patients with adverse events
Time frame: For each treatment combination, from screening (Day -28 to -1) either for up to 1.5 years or up to 30 days follow-up period after discontinuation
To investigate the safety and tolerability of capivasertib when given in combination with novel agents (enzalutamide and abiraterone) to patients with metastatic CRPC.
6 secondary outcomes
Area under curve (AUC) for capivasertib to characterize pharmacokinetics (PK) for each treatment combination
Time frame: For capivasertib and enzalutamide combination, full sampling on day 25 and on day 53; for capivasertib and abiraterone combination, full sampling on day 25.
Maximum plasma concentration (Cmax) for capivasertib to characterize PK for each treatment combination
Time frame: For capivasertib and enzalutamide combination, full sampling on day 25 and on day 53; for capivasertib and abiraterone combination, full sampling on day 25.
Soft tissue objective response rate (ORR) and radiological ORR for efficacy analyses of capivasertib for each treatment combination
Time frame: From screening (-28 Day) to every 8 weeks after cycle 1 day 1 for the first 24 weeks and every 12 weeks thereafter up to 1.5 years for each treatment combination
Duration of response (DoR) for efficacy analyses of capivasertib for each treatment combination
Time frame: From screening (-28 Day) to every 8 weeks after cycle 1 day 1 for the first 24 weeks and every 12 weeks thereafter up to 1.5 years for each treatment combination
Percentage change in tumour size for efficacy analyses of capivasertib for each treatment combination
Time frame: From screening (-28 Day) to every 8 weeks after cycle 1 day 1 for the first 24 weeks and every 12 weeks thereafter up to 1.5 years for each treatment combination
Radiographic progression free survival (rPFS) for efficacy analyses of capivasertib for each treatment combination
Time frame: From screening (-28 Day) to every 8 weeks after cycle 1 day 1 for the first 24 weeks and every 12 weeks thereafter up to 1.5 years for each treatment combination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Derived from this study: PubMed 36572571Shore N, Mellado B, Shah S, Hauke R, Costin D, Adra N, Cullberg M, Teruel CF, Morris T. A Phase I Study of Capivasertib in Combination With Abiraterone Acetate in Patients With Metastatic Castration-Resistant Prostate Cancer. Clin Genitourin Cancer. 2023 Apr;21(2):278-285. doi: 10.1016/j.clgc.2022.11.017. Epub 2022 Nov 26.
- CSR SynopsisLink provided by the sponsor.
- Results of this clinical trial are available on www.astrazenecaclinicaltrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Capivasertib, Enzalutamide and Abiraterone in people with Prostate Cancer, run by AstraZeneca at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with dose limiting toxicity (DLT) for Part A1 (time frame: Day 1 to day 56 for Part A1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04087174, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.