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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524920-23 | Other Identifier | EU CT number |
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The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of multiple anti-cancer agents in participants with metastatic prostate cancer.
This is a multicentre, open-label and platform study to evaluate multiple anti-cancer agents in participants with metastatic prostate cancer. This platform study will comprise a series of substudies. Each substudy will follow a 2-part structure (unless otherwise stated in the individual substudy):
Sub-study 1 focuses on a specific combination regimen and it will assess the safety, tolerability, PK, pharmacodynamics, and preliminary anti-tumour activity of AZD2265 (FPI-2265) in combination with AZD9574 compared with AZD2265 (FPI-2265) monotherapy and with standard-of-care (SoC) docetaxel chemotherapy in participants with metastatic castration resistant prostate cancer (mCRPC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sub study 1 Part A (SS1A): escalating dose levels of AZD9574 in combination with AZD2265 (FPI-2265) | Experimental | Participants will receive escalating dose levels of AZD9574 once daily in combination with AZD2265 (FPI-2265) once every 6 weeks (Q6W). |
|
| Sub study 1 Part B (SS1B): selected dose of AZD9574 in combination with AZD2265 (FPI-2265) | Experimental | Participants will receive AZD9574 chosen from the DE phase once daily in combination with AZD2265 (FPI-2265) Q6W. |
|
| SS1B: AZD2265 (FPI-2265) monotherapy | Experimental | Participants will receive AZD2265 (FPI-2265) monotherapy Q6W. |
|
| SS1B: Docetaxel | Active Comparator | Participants will receive docetaxel as a standard of care (SoC) once every 3 weeks (Q3W). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2265 (FPI-2265) | Drug | AZD2265 (FPI-2265) will be administered as an intravenous (IV) injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of participants with treatment-emergent adverse events (TEAEs)including serious adverse events (SAEs), treatment-related AEs (TRAEs) and adverse events of special interests (AESIs) | To assess the safety and tolerability of AZD9574 in combination with AZD2265 (FPI-2265). | Up to approximately 1 year after last dose |
| Part A: Number of participants with dose limiting toxicities (DLTs) | To assess the safety and tolerability, and characterise the DLTs of AZD9574 in combination with AZD2265 (FPI-2265). | From date of first dose up to approximately 2 cycles (up to 3 months) |
| Part B: Number of participants with TEAEs | To further assess the safety and tolerability, and determine the recommended Phase 3 dose (RP3D) of AZD9574 in combination with AZD2265 (FPI-2265). | Up to approximately 1 year after last dose |
| Part B: Prostate Specific Antigen 50 (PSA50) response rate | PSA50 response rate is defined as proportion of participants achieving a ≥ 50% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later, and occurring prior to confirmed PSA progression. PSA50 will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265). | Up to 3 years 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Part A and Part B: PSA50 response rate | PSA50 response rate is defined as proportion of participants achieving a ≥ 50% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later, and occurring prior to confirmed PSA progression. PSA50 will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265) (Part A) and to demonstrate effectiveness of AZD2265 (FPI-2265) + AZD9574 relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B). |
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Inclusion Criteria:
Inclusion Criteria for Sub study 1:
Exclusion Criteria:
Exclusion Criteria for Sub study 1:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Not yet recruiting | Encino | California | 91436 | United States | |
| Research Site |
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 requests 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 shared.
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.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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|
| AZD9574 | Drug | AZD9574 will be administered orally. |
|
| Docetaxel | Drug | Docetaxel will be administered as an IV infusion. |
|
| AZD2287 (Imaging agent) | Drug | AZD2287 will be administered as an IV injection. |
|
| Up to 3 years 4 months |
| Part A and Part B: Prostate Specific Antigen 90 (PSA90) response rate | PSA90 response rate is defined as proportion of participants achieving a ≥ 90% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later, and occurring prior to confirmed PSA progression. PSA90 will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265) (Part A and Part B) and to demonstrate effectiveness of AZD2265 (FPI-2265) + AZD9574 relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B only). | Up to 3 years 4 months |
| Part A and Part B: Time to PSA50 (TTPSA50) response | TTPSA50 response is defined as the time from date of randomisation/first dose of study intervention until the date of first documented PSA50 response (≥ 50% decrease in PSA from baseline), confirmed by a second consecutive PSA assessment at least 3 weeks later. TTPSA50 response will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265). | Up to 3 years 4 months |
| Part A and Part B: Time to PSA90 (TTPSA90) response | TTPSA90 response is defined as the time from date of randomisation/first dose of study intervention until the date of first documented PSA90 response (≥ 90% decrease in PSA from baseline, respectively), confirmed by a second consecutive PSA assessment at least 3 weeks later. TTPSA90 response will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265). | Up to 3 years 4 months |
| Part A and Part B: Duration of PSA50 (DoPSA50) response | DoPSA50 response is defined as the time from the date of first documented PSA50 response, that is subsequently confirmed by a second consecutive PSA assessment at least 3 weeks later, until the date of documented PSA progression. DoPSA50 response will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265). | Up to 3 years 4 months |
| Part A and Part B: Duration of PSA90 (DoPSA90) response | DoPSA90 response is defined as the time from the date of first documented PSA90 response, that is subsequently confirmed by a second consecutive PSA assessment at least 3 weeks later, until the date of documented PSA progression. DoPSA90 response will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265). | Up to 3 years 4 months |
| Part A and Part B: Time to PSA progression | TTPSA progression is defined as time from the date of randomisation/first dose of study intervention until the date of documented PSA progression or the last PSA result in the absence of progression. PSA progression is defined as an increase in PSA of ≥ 25% from the nadir and an absolute increase of at least 2 ng/mL above nadir beyond 12 weeks. PSA progression must be confirmed by a second value taken at least 3 weeks later. TTPSA progression will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265). | Up to 3 years 4 months |
| Part A and Part B: PSA over time | PSA over time is defined as the longitudinal change in serum PSA from baseline across all on-study timepoints. PSA over time will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265). | Up to 3 years 4 months |
| Part A and Part B: Radiographic Progression-free survival (rPFS) | rPFS is defined as the time from date of randomisation/first dose of study intervention until the date of objective disease progression according to response evaluation criteria in solid tumors (RECIST) 1.1 (for soft tissue disease) and prostate cancer working group 3 (PCWG3) criteria (for bone disease) as assessed by the investigator at the local site, or death (by any cause in the absence of progression), regardless of whether the participant withdraws from therapy or receives another anti-cancer therapy prior to progression. rPFS will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265) (Part A and Part B) and to demonstrate effectiveness of AZD2265 (FPI-2265) + AZD9574 relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B only). | From Day 1 to 3 years 4 months |
| Part A and Part B: Overall Response Rate (ORR) | The ORR is defined as the percentage of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as the time from the date of first documented objective response (which is subsequently confirmed) until the date of radiographic disease progression or censored according to rules for rPFS. The ORR will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265) (Part A and Part B) and to demonstrate effectiveness of AZD2265 (FPI-2265) + AZD9574 relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B only). | From Day 1 to 3 years 4 months |
| Part A and Part B: Best Overall Response (BOR) | The BOR is defined as the best overall visit response the participant achieves as determined by the investigator at the local site. The BOR will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265) (Part A and Part B) and to demonstrate effectiveness of AZD2265 (FPI-2265) + AZD9574 relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B only). | From Day 1 to 3 years 4 months |
| Part A and Part B: Duration of response (DoR) | The DoR is defined based on RECIST 1.1 (for soft tissue disease) and PCWG3 criteria (for bone disease) as the time from the date of first documented objective response (which is subsequently confirmed) until date of radiographic disease progression or censored according to rules for rPFS. The DoR will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265) (Part A and Part B) and to demonstrate effectiveness of AZD2265 (FPI-2265) + AZD9574 relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B only). | From Day 1 to 3 years 4 months |
| Part A and Part B: Time to Response (TTR) | The TTR is defined as the time from the date of randomisation/first dose of study intervention until the date of first documented objective response, which is subsequently confirmed. The TTR will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265) (Part A and Part B) and to demonstrate effectiveness of AZD2265 (FPI-2265) + AZD9574 relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B only). | From Day 1 to 3 years 4 months |
| Part A and Part B: Percentage change in tumour size | To assess the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265). | From Day 1 to 3 years 4 months |
| Part A and Part B: Plasma concentration of AZD9574 | To determine the PK of AZD9574 in combination with AZD2265 (FPI-2265). | From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days) |
| Part A and Part B: Plasma concentration of AZD2265 (FPI-2265) | To determine the PK of AZD9574 in combination with AZD2265 (FPI-2265). | From Cycle 1 Day 1 to Cycle 2 Day 1 (each cycle will be 42 days) |
| Part A and Part B: Area under the concentration time curve (AUC) | To determine the PK (AUC) of AZD9574 in combination with AZD2265 (FPI-2265). | From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days) |
| Part A and Part B: Maximum observed drug concentration (Cmax) | To determine the PK (Cmax) of AZD9574 in combination with AZD2265 (FPI-2265). | From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days) |
| Part A and Part B: Time to reach Cmax (tmax) | To determine the PK (tmax) of AZD9574 in combination with AZD2265 (FPI-2265). | From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days) |
| Part A and Part B: Terminal elimination half-life (t½λz) | To determine the PK (t½λz) of AZD9574 in combination with AZD2265 (FPI-2265). | From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days) |
| Part A and Part B: Change from baseline in study-specific biomarker ABC in response to treatment | To investigate pharmacodynamics of AZD9574 in combination with AZD2265 (FPI-2265) (for Part A and Part B) and of AZD2265 (FPI-2265) monotherapy (for Part B only). | Up to 3 years 4 months |
| Part A and Part B: Change from baseline in study-specific biomarker XYZ in response to treatment | To investigate study-specific XYZ expression and relationship to response to the treatment. | Up to 3 years 4 months |
| Recruiting |
| South Pasadena |
| California |
| 91030 |
| United States |
| Research Site | Recruiting | Miami | Florida | 33165 | United States |
| Research Site | Not yet recruiting | Tampa | Florida | 33612 | United States |
| Research Site | Not yet recruiting | Metairie | Louisiana | 70006 | United States |
| Research Site | Not yet recruiting | Minneapolis | Minnesota | 55455 | United States |
| Research Site | Not yet recruiting | Omaha | Nebraska | 68130 | United States |
| Research Site | Not yet recruiting | New York | New York | 10065 | United States |
| Research Site | Not yet recruiting | Portland | Oregon | 97239 | United States |
| Research Site | Not yet recruiting | Houston | Texas | 77030 | United States |
| Research Site | Not yet recruiting | North Adelaide | 5000 | Australia |
| Research Site | Not yet recruiting | Essen | 45147 | Germany |
| Research Site | Not yet recruiting | Jena | 07747 | Germany |
| Research Site | Not yet recruiting | Rostock | 18057 | Germany |
| Research Site | Not yet recruiting | Tübingen | 72076 | Germany |
| Research Site | Not yet recruiting | Bergamo | 24127 | Italy |
| Research Site | Not yet recruiting | Meldola | 47014 | Italy |
| Research Site | Not yet recruiting | Milan | 20133 | Italy |
| Research Site | Not yet recruiting | Milan | 20141 | Italy |
| Research Site | Not yet recruiting | Roma | 00168 | Italy |
| Research Site | Not yet recruiting | Seoul | 03080 | South Korea |
| Research Site | Not yet recruiting | Seoul | 03722 | South Korea |
| Research Site | Not yet recruiting | Seoul | 06351 | South Korea |
| Research Site | Not yet recruiting | Seoul | 06591 | South Korea |
| Research Site | Not yet recruiting | Seoul | 5505 | South Korea |
| Research Site | Not yet recruiting | Barcelona | 08028 | Spain |
| Research Site | Not yet recruiting | L'Hospitalet de Llobregat | 08908 | Spain |
| Research Site | Not yet recruiting | Madrid | 28031 | Spain |
| Research Site | Not yet recruiting | Madrid | 28041 | Spain |
| Research Site | Not yet recruiting | Pamplona | 31008 | Spain |
| Research Site | Not yet recruiting | Fulham | SW3 6JJ | United Kingdom |
| Research Site | Not yet recruiting | Guildford | CU2 7XX | United Kingdom |
| Research Site | Not yet recruiting | London | WC1E 6DB | United Kingdom |
| Research Site | Not yet recruiting | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Research Site | Not yet recruiting | Oxford | OX3 7LE | United Kingdom |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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