An Open-label, Phase II Study of AZD4635 in Patients With Prostate Cancer

Part of paid clinical trials in Denver, Colorado.

Sponsor
AstraZeneca
Study ID
NCT04089553
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD4635 — DRUG
    In Module 1, participants will receive AZD4635 75 mg capsule orally QD for first 14 days and thereafter will continue to receive 75 mg orally QD Q4W. In Module 2, participants will receive AZD4635 50 mg / 75 mg capsule orally QD Q2W of 28-day cycle for the first 4 doses and Q4W thereafter. In both modules, participants will receive treatment until will derive clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurs first.
  • Oleclumab — DRUG
    In Module 2, participants will receive oleclumab 1500 mg IV (solution for infusion after dilution, 50 mg/mL) Q2W of 28-day cycle for the first 4 doses and Q4W thereafter until will derive clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurs first.
  • Durvalumab — DRUG
    In Module 1 after monotherapy of AZD4635, participants will receive durvalumab 1500 mg IV (solution for infusion after dilution, 50 mg/mL) Q4W until will derive clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurs first.

Study Details

This is an open-label Phase II modular study in participants with prostate cancer which will assess safety, efficacy, and tolerability of AZD4635 in combination with other therapeutic agents in different treatment arms (referred to as modules). Combinations to be studied include: 1) Module 1: AZD4635 plus durvalumab; 2) Module 2: AZD4635 plus oleclumab.

Key Dates

Start date
Aug 29, 2019
Status verified
Mar 2024
Primary completion
Jun 16, 2021
Completion
Apr 11, 2023

Study Design

Enrollment
59 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1 (AZD4635 75 mg + Durvalumab 1500 mg)
    Participants will receive monotherapy of AZD4635 75 mg orally once daily (QD) for first 14 days and thereafter will continue to receive 75 mg orally QD in combination with durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W) until will derive clinical benefit as judged by the investigator, confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurs first.
  • Experimental: Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg)
    Participants will receive combination therapy of AZD4635 (50 mg / 75 mg orally QD) and oleclumab 1500 mg IV (every 2 weeks of 28-day cycle for the first 4 doses and Q4W thereafter) until will derive clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurs first.

Primary Outcome Measure

Percentage of Participants With Confirmed Objective Response Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Baseline (Day -28) through end of study (last participant last visit) (approximately 22 months) ]

Locations (9)

FacilityCityStateZIPSite coordinators
Research SiteDenverColorado80218-
Research SiteFort MyersFlorida33916-
Research SiteSt. PetersburgFlorida33705-
Research SiteWest Palm BeachFlorida33401-
Research SiteDecaturIllinois62526-
Research SiteNew YorkNew York10032-
Research SiteDurhamNorth Carolina27710-
Research SiteChattanoogaTennessee37404-
Research SiteNashvilleTennessee37203-

Find similar trials in Denver, CO

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Research Site· Denver, COResearch Site· Fort Myers, FLResearch Site· St. Petersburg, FLResearch Site· West Palm Beach, FLResearch Site· Decatur, ILResearch Site· New York, NY

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