Testing Two Oral Drugs Combination (Cediranib and Olaparib) Compared to a Single Drug (Olaparib) for Men With Advanced Prostate Cancer

Part of paid clinical trials in La Jolla, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02893917
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Advanced Prostate Adenocarcinoma With Neuroendocrine Differentiation
  • Castration-Resistant Prostate Carcinoma
  • Metastatic Prostate Adenocarcinoma With Neuroendocrine Differentiation
  • Metastatic Prostate Carcinoma
  • Prostate Adenocarcinoma With Neuroendocrine Differentiation
  • Stage IV Prostate Adenocarcinoma AJCC v7

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cediranib — DRUG
    Given PO
  • Olaparib — DRUG
    Given PO

Study Details

This randomized phase II trial studies how well olaparib with or without cediranib works in treating patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Cediranib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving olaparib and cediranib may help treat patients with castration-resistant prostate cancer.

Key Dates

Start date
Aug 11, 2017
Status verified
Dec 2025
Primary completion
Mar 14, 2023
Completion
May 31, 2027

Study Design

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

Arms

  • Experimental: Arm A (olaparib, cediranib)
    Patients receive olaparib PO BID and cediranib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Active Comparator: Arm B (olaparib)
    Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Radiographic Progression Free Survival [ Time Frame: Time interval from random assignment to the date when the first site of disease is found to progress, or death, whichever occurs first, assessed up to 5 years ]

Locations (16)

FacilityCityStateZIPSite coordinators
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
UC San Diego Medical Center - HillcrestSan DiegoCalifornia92103-
Smilow Cancer Center/Yale-New Haven HospitalNew HavenConnecticut06510-
Yale UniversityNew HavenConnecticut06520-
Moffitt Cancer CenterTampaFlorida33612-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Brigham and Women's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
Wayne State University/Karmanos Cancer InstituteDetroitMichigan48201-
Weisberg Cancer Treatment CenterFarmington HillsMichigan48334-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-
VCU Massey Comprehensive Cancer CenterRichmondVirginia23298-

Find similar trials in La Jolla, CA

By research site
UC San Diego Moores Cancer Center· La Jolla, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAUC San Diego Medical Center - Hillcrest· San Diego, CASmilow Cancer Center/Yale-New Haven Hospital· New Haven, CTYale University· New Haven, CTMoffitt Cancer Center· Tampa, FL

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