Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18-99
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

Qualifiers

Participants with a diagnosis of histologically confirmed adenocarcinoma of the prostate (no small cell, neuroendocrine, sarcomatoid, spindle or signet cell).

Minimum life expectancy of 3 months or more.

Eastern Cooperative Oncology Group (ECOG) performance status of O or 1 at screening, with no deterioration.

PCWG3 (Prostate Cancer Working Group 3) modified RECIST Version 1.1 evaluable disease.

Disqualifiers

Any evidence of non adenocarcinomatous forms of prostate cancer (including small cell, spindle cell, signet cell, neuroendocrine, sarcomatous).

Known, unresolved urinary tract obstruction.

Participants with a history of central nervous system metastases.

Symptomatic malignant spinal cord compression or findings indicative of impending cord compression.

Trial design

Treatments tested in this trial

  • AZD2265 (FPI-2265)
  • AZD9574
  • Docetaxel
  • AZD2287 (Imaging agent)

Treatment groups

152 Participants
are divided into 4 treatment groups

Sponsors and collaborators