Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations

Part of paid clinical trials in Costa Mesa, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03212274
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Advanced Malignant Solid Neoplasm
  • Glioblastoma
  • Recurrent Cholangiocarcinoma
  • Recurrent Glioma
  • Recurrent Malignant Solid Neoplasm
  • WHO Grade 2 Glioma
  • WHO Grade 3 Glioma

Eligibility Criteria

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

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tissue biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo a CT scan
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo a MRI
  • Olaparib — DRUG
    Given PO

Study Details

This phase II trial studies how well olaparib works in treating patients with glioma, cholangiocarcinoma, or solid tumors with IDH1 or IDH2 mutations that has spread from where it first started (primary site) to other places in the body (metastatic) and that does not respond to treatment (refractory). Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Jan 30, 2019
Status verified
Jan 2026
Primary completion
Apr 2, 2025
Completion
Jul 28, 2026

Study Design

Enrollment
89 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (olaparib)
    Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression, unacceptable toxicity, withdrawal of consent or death. Patients undergo a CT scan and/or MRI, as well as a tumor biopsy and blood sample collection on study.

Primary Outcome Measure

Overall response rate [ Time Frame: Up to completion of 8 weeks of treatment ]

Locations (51)

FacilityCityStateZIPSite coordinators
UC Irvine Health Cancer Center-NewportCosta MesaCalifornia92627-
Los Angeles General Medical CenterLos AngelesCalifornia90033-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
USC Norris Oncology/Hematology-Newport BeachNewport BeachCalifornia92663-
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
Stanford Cancer Institute Palo AltoPalo AltoCalifornia94304-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
Smilow Cancer Center/Yale-New Haven HospitalNew HavenConnecticut06510-
Yale UniversityNew HavenConnecticut06520-
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007-
UM Sylvester Comprehensive Cancer Center at Coral GablesCoral GablesFlorida33146-
UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield BeachFlorida33442-
UF Health Cancer Institute - GainesvilleGainesvilleFlorida32610-
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136-
UM Sylvester Comprehensive Cancer Center at PlantationPlantationFlorida33324-
Emory Saint Joseph's HospitalAtlantaGeorgia30342-
Emory University Hospital MidtownAtlantaGeorgia30308-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
University of Kansas Clinical Research CenterFairwayKansas66205-
University of Kansas Cancer CenterKansas CityKansas66160-
University of Kansas Cancer Center-Overland ParkOverland ParkKansas66210-
University of Kansas Hospital-Indian Creek CampusOverland ParkKansas66211-
University of Kansas Hospital-Westwood Cancer CenterWestwoodKansas66205-
University of Kentucky/Markey Cancer CenterLexingtonKentucky40536-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Brigham and Women's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
Siteman Cancer Center at Saint Peters HospitalCity of Saint PetersMissouri63376-
Siteman Cancer Center at West County HospitalCreve CoeurMissouri63141-
University of Kansas Cancer Center - NorthKansas CityMissouri64154-
University of Kansas Cancer Center - Lee's SummitLee's SummitMissouri64064-
University of Kansas Cancer Center at North Kansas City HospitalNorth Kansas CityMissouri64116-
Siteman Cancer Center at Christian HospitalSt LouisMissouri63136-
Siteman Cancer Center-South CountySt LouisMissouri63129-
Washington University School of MedicineSt LouisMissouri63110-
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanonNew Hampshire03756-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University HospitalNew BrunswickNew Jersey08903-
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew YorkNew York10016-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Duke University Medical CenterDurhamNorth Carolina27710-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
Vanderbilt Breast Center at One Hundred OaksNashvilleTennessee37204-
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-
M D Anderson Cancer CenterHoustonTexas77030-
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112-
University of Wisconsin Carbone Cancer Center - University HospitalMadisonWisconsin53792-

Find similar trials in Costa Mesa, CA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
UC Irvine Health Cancer Center-Newport· Costa Mesa, CALos Angeles General Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAUSC Norris Oncology/Hematology-Newport Beach· Newport Beach, CAUC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAStanford Cancer Institute Palo Alto· Palo Alto, CA

Related Studies