AZD2284 for Prostate Cancer
Recruiting in Palo Alto (17 mi)
+8 other locations
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: AstraZeneca
No Placebo Group
Trial Summary
What is the purpose of this trial?The main purpose of the study is to assess the safety and tolerability of AZD2284, AZD2287, and AZD2275.
Eligibility Criteria
This trial is for men with advanced prostate cancer that's resistant to hormone therapy. They must have low testosterone from treatment, good organ function, and be relatively fit (ECOG 0 or 1). They need at least one metastatic lesion visible on scans and a confirmed diagnosis of adenocarcinoma or neuroendocrine prostate cancer.Inclusion Criteria
I have undergone treatment to lower my testosterone for prostate cancer.
My organs are working well.
I am fully active or restricted in physically strenuous activity but can do light work.
+2 more
Exclusion Criteria
Clinically relevant proteinuria
Concurrent severe and/or uncontrolled illness not related to cancer and/or social situation that would limit compliance with study requirements
I haven't had radiopharmaceutical treatment in the last 6 weeks.
+4 more
Participant Groups
The study tests the safety and tolerability of three drugs: AZD2284, AZD2287, and AZD2275 in patients with metastatic castration-resistant prostate cancer. It aims to find out what doses are safe and how the body handles these drugs.
10Treatment groups
Experimental Treatment
Group I: Part B: Cohort E2Experimental Treatment3 Interventions
Participants will receive dose of AZD2284 determined by the earlier results. Expansion cohort may be opened to further characterize the safety and efficacy of the dose level.
Group II: Part B: Cohort E1Experimental Treatment3 Interventions
Participants will receive dose of AZD2284 determined by the earlier results. Expansion cohort may be opened to further characterize the safety and efficacy of the dose level.
Group III: Part B (Actinium-225 Dose Escalation): medium dose: AZD2284Experimental Treatment3 Interventions
Participants will receive AZD2287 (± AZD2275 as determined in Part A). If eligible for treatment, will receive medium dose of AZD2284.
Group IV: Part B (Actinium-225 Dose Escalation): low dose: AZD2284Experimental Treatment3 Interventions
Participants will receive AZD2287 (± AZD2275 as determined in Part A). If eligible for treatment, will receive low dose of AZD2284.
Group V: Part B (Actinium-225 Dose Escalation): high dose 2: AZD2284Experimental Treatment3 Interventions
Participants will receive AZD2287 (± AZD2275 as determined in Part A). If eligible for treatment, will receive high dose of AZD2284.
Group VI: Part B (Actinium-225 Dose Escalation): high dose 1: AZD2284Experimental Treatment3 Interventions
Participants will receive AZD2287 (± AZD2275 as determined in Part A). If eligible for treatment, will receive high dose of AZD2284.
Group VII: Part A: Cohort A3: AZD2275 + AZD2287 (Cold +Hot)Experimental Treatment3 Interventions
Participants will receive medium dose of AZD2275 followed by 1 dose of AZD2287. If eligible for treatment, will receive low dose of AZD2284.
Group VIII: Part A: Cohort A2: AZD2275 + AZD2287 (Cold +Hot)Experimental Treatment3 Interventions
Participants will receive low dose of AZD2275 followed by 1 dose of AZD2287. If eligible for treatment, will receive low dose of AZD2284.
Group IX: Part A: Cohort A1: AZD2287 (Hot only)Experimental Treatment2 Interventions
Participants will receive 1 dose of AZD2287. If eligible for treatment, will receive low dose of AZD2284.
Group X: Part A Expansion: AZD2287 + AZD2275 (Cold + Hot)Experimental Treatment2 Interventions
Participants will receive dose of AZD2275 determined earlier in the study followed by 1 dose of AZD2287.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Research SiteChicago, IL
Research SiteBoston, MA
Research SiteOmaha, NE
Research SiteMiami, FL
More Trial Locations
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Who Is Running the Clinical Trial?
AstraZenecaLead Sponsor