Phase Ib/II Study of Multiple Anti-Cancer Agents for Metastatic Prostate Cancer
This study is looking at several anti-cancer treatments for men with metastatic prostate cancer (cancer that has spread to other parts of the body). Researchers want to understand how safe these treatments are, how well your body handles them, and if they show early signs of shrinking the cancer. The treatments being studied include AZD2265 (FPI-2265), AZD9574, and docetaxel. One part of the study will compare AZD2265 (FPI-2265) combined with AZD9574 against AZD2265 (FPI-2265) alone, and against standard docetaxel chemotherapy. To join, you must be a man between 18 and 99 years old with confirmed prostate cancer that has spread, and have a life expectancy of at least 3 months. The study will consider a treatment successful if it leads to a 50% or more decrease in your PSA (Prostate-specific antigen) levels.
- Study design
- This is a multi-center, open-label study with a planned enrollment of 152 participants. It is designed as a platform study with different substudies, each having a dose escalation and a dose optimization/expansion phase.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for side effects for up to approximately 1 year after their last dose of treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer
At a glance
Conditions
Where it's being run
37 sites across 14 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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)Up to approximately 1 year after last dose
To assess the safety and tolerability of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
- Part A: Number of participants with dose limiting toxicities (DLTs)From date of first dose up to approximately 2 cycles (up to 3 months)
To assess the safety and tolerability, and characterise the DLTs of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
- Part B: Number of participants with TEAEsUp to approximately 1 year after last dose
To further assess the safety and tolerability, and determine the recommended Phase 3 dose (RP3D) of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
- Part B: Prostate Specific Antigen 50 (PSA50) response rateUp to 3 years 4 months
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 palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).