Combined treatment approach in metastatic prostate cancer using AZD2265 (FPI-2265) with palacaparib or docetaxel

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, platform study in metastatic prostate cancer. It uses a two-part design: dose escalation to identify safe dose levels and a dose optimization/expansion to refine the recommended dose and assess preliminary efficacy. Sub-study 1 evaluates AZD2265 (FPI-2265) in combination with palacaparib versus monotherapy and versus standard-of-care docetaxel, with an imaging agent included for assessment. Primary endpoints include safety, pharmacokinetics, pharmacodynamics, and PSA response as a potential early efficacy signal. Eligible participants have metastatic castration-resistant disease, prior AR pathway inhibitor exposure, adequate organ function, and measurable disease per PCWG3 criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants with a diagnosis of histologically confirmed adenocarcinoma of the prostate (no small cell, neuroendocrine, sarcomatoid, spindle or signet cell).
2. Minimum life expectancy of 3 months or more.
3. Eastern Cooperative Oncology Group (ECOG) performance status of O or 1 at screening, with no deterioration.
4. PCWG3 (Prostate Cancer Working Group 3) modified RECIST Version 1.1 evaluable disease.
5. Must have received at least one novel androgen receptor pathway inhibitor (ARPI), such as enzalutamide or darolutamide or apalutamide or abiraterone acetate.
6. Must have one or more unresectable metastatic lesions.
7. Must have had prior orchiectomy and/or ongoing androgen deprivation therapy, and a castrate level of serum testosterone (\<50ng/dL or \<l.7nmol/L).
8. Progressive metastatic castration-resistant prostate cancer (mCRPC) following the most recent treatment at time of study entry.
9. Adequate organ and marrow function.
10. Non sterilised participants who are sexually active with a partner of childbearing potential must use a condom (plus spermicide, if available), must refrain from fathering a child, freezing or donating sperm, and it is recommended for the partner to also use a highly effective contraceptive method.

Inclusion Criteria for Sub study 1:

1. Must have received a single line of ARPI, such as enzalutamide, darolutamide, apalutamide or abiraterone acetate. Participants who were exposed to more than one ARPI due to toxicity or intolerance (not due to disease progression) are eligible.
2. PSMA positive mCRPC by computed tomography positron emission tomography, obtained with PSMA ligand defined as at least 1 PSMA positive metastatic lesion with tracer uptake greater than liver, and no PSMA negative lesions. All measurable or intraprostatic lesions must be PSMA positive.
3. Capable of self-administering oral formulations.

Exclusion Criteria:

1. Any evidence of non adenocarcinomatous forms of prostate cancer (including small cell, spindle cell, signet cell, neuroendocrine, sarcomatous).
2. Known, unresolved urinary tract obstruction.
3. Participants with a history of central nervous system metastases.
4. Symptomatic malignant spinal cord compression or findings indicative of impending cord compression.
5. Participants with a history of leptomeningeal carcinomatosis.
6. Previous or concurrent cancer distinct from the cancer under investigation in primary site or histology .
7. Concurrent serious medical conditions.
8. Previous history of interstitial lung disease or non-infectious pneumonitis.
9. Participants with a history or clinical/laboratory features suggestive of myelodysplastic syndrome or acute myeloid leukaemia.
10. Persistent toxicities caused by previous therapy.
11. Participants unable to swallow orally administered medications or with gastrointestinal disorders likely to interfere with absorption.
12. Active infection, including tuberculosis, hepatitis C virus, and hepatitis B virus infection.
13. Known hypersensitivity to study intervention or any of their excipients.

Exclusion Criteria for Sub study 1:

1. History of uncontrolled seizures or requirement for \>2 antiepileptic drugs.
2. History of severe brain injury or stroke.
3. Skeletal metastases demonstrating a superscan appearance on bone scan.
4. Participants have received prior therapy with palacaparib (AZD9574) or more than 1 prior line of any other Poly-ADP-ribose polymerase inhibitor (PARPi)-based regimen (either as a treatment or as maintenance).

Where it's running

• Research Site
  South Pasadena, California, United States Recruiting
• Research Site
  Miami, Florida, United States Recruiting
• Research Site
  Omaha, Nebraska, United States Recruiting
• Research Site
  Duarte, California, United States Not yet recruiting
• Research Site
  Encino, California, United States Not yet recruiting
• Research Site
  Orlando, Florida, United States Not yet recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.