Ceralasertib (AZD6738) Alone and in Combination With Olaparib or Durvalumab in Patients With Solid Tumors

Part of paid clinical trials in Duarte, California.

Sponsor
Rahul Aggarwal
Study ID
NCT03682289
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Ceralasertib — DRUG
    Given orally
  • Olaparib — DRUG
    Given orally
  • Durvalumab — DRUG
    Given intravenously (IV)

Study Details

This phase II trial studies how well ceralasertib, am Ataxia telangiectasia and Rad3-related (ATR) kinase inhibitor, works alone or in combination with olaparib or durvalumab in treating participants with renal cell carcinoma (RCC), urothelial carcinoma, all pancreatic cancers, endometrial cancer, and other solid tumors excluding clear cell ovarian cancer that have spread to nearby tissue or lymph nodes or other parts of the body. ATR kinase inhibitor AZD6738 and olaparib or durvalumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not known if giving ATR kinase inhibitor AZD6738 with or without olaparib or durvalumab may work better in treating participants with solid tumors.

Key Dates

Start date
Jan 17, 2019
Status verified
Apr 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
83 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (Ceralasertib Monotherapy)
    As monotherapy ceralasertib will be given at a starting dose of 160 mg two times per day (BID), on days 1-14 of a 28-day cycle for participants who are BAF250a negative or show an ATM-Mutation by CLIA assay. Treatment will continue until disease progression, unacceptable toxicity, or participant withdrawal from study, whichever occurs first.
  • Experimental: Arm II (Ceralasertib, Olaparib)
    In combination with olaparib, ceralasertib will be given at a continuous daily dose of 160 mg daily days 1-7 in each 28-day cycle. Olaparib will be given at a starting dose of 300 mg twice daily days 1-28 of a 28-day cycle for participants who are BAF250a positive. Treatment will continue until disease progression, unacceptable toxicity, or participant withdrawal from study, whichever occurs first.
  • Experimental: Arm III (Ceralasertib, Durvalumab)
    In combination with durvalumab, ceralasertib will be given at a continuous daily dose of 240 mg BID days 1-7 of a 28-day dosing schedule. Durvalumab will be given at a flat dose of 1500 mg IV on day 8 of a 28-day cycle for participants with histologically confirmed endometrial cancers. Participants treated with the combination of ceralasertib plus durvalumab may continue treatment beyond first radiographic progression until the occurrence of either confirmed radiographic progression or clinical progression, whichever occurs first.

Primary Outcome Measure

Objective response rate (ORR) (ARID1A cohort) [ Time Frame: Up to 3 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
University of California, San FranciscoSan FranciscoCalifornia94143-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-

Find similar trials in Duarte, CA

By condition
Endometrial cancerProstate cancerKidney cancer
By specialty
OncologyGynecologic oncologyWomen's healthProstate oncologyMen's healthUrology
By research site
City of Hope Comprehensive Cancer Center· Duarte, CAUniversity of California, San Francisco· San Francisco, CAUniversity of Chicago Comprehensive Cancer Center· Chicago, IL

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