Active — Not RecruitingPhase 2

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

United States83 participantsStarted 2019-01-17

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients must provide written informed consent prior to performance of study-specific procedures or assessments.
✓. ARID1A Subgroup (N = 39):
✓. Histologically confirmed locally advanced or metastatic solid tumor malignancy with progression on at least one prior systemic therapy, including one of the following tumor types:
✓. Formalin-fixed paraffin embedded tumor tissue evaluable for BAF250a expression by ARID1A immunohistochemistry. Primary or metastatic tumor tissue is permissible. Patients without evaluable archival tissue may undergo optional tumor biopsy during Screening if other eligibility criteria have been met
✓. Measurable disease by RECIST 1.1
✓. ATM Loss Subgroup (N = 20):
✓. Histologically confirmed locally advanced or metastatic solid tumor malignancy with progression on at least one prior systemic therapy, including one of the following tumor types:
✓. Archival tumor tissue evaluable for ATM expression by immunohistochemistry (IHC)

Exclusion criteria

What they're measuring

Objective response rate (ORR) (ARID1A cohort)

Timeframe: Up to 3 years

Composite Prostate Cancer Patient Response Rate (prostate cancer only)

Timeframe: Up to 3 years

Objective response rate (ORR) for other solid tumors

Timeframe: Up to 3 years

Objective response rate (ORR) for endometrial cohort

Timeframe: Up to 3 years

Trial details

NCT IDNCT03682289

SponsorRahul Aggarwal

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-31

View on ClinicalTrials.gov More Clear Cell Renal Cell Carcinoma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients must provide written informed consent prior to performance of study-specific procedures or assessments.
✓. ARID1A Subgroup (N = 39):
✓. Histologically confirmed locally advanced or metastatic solid tumor malignancy with progression on at least one prior systemic therapy, including one of the following tumor types:
✓. Formalin-fixed paraffin embedded tumor tissue evaluable for BAF250a expression by ARID1A immunohistochemistry. Primary or metastatic tumor tissue is permissible. Patients without evaluable archival tissue may undergo optional tumor biopsy during Screening if other eligibility criteria have been met
✓. Measurable disease by RECIST 1.1
✓. ATM Loss Subgroup (N = 20):
✓. Histologically confirmed locally advanced or metastatic solid tumor malignancy with progression on at least one prior systemic therapy, including one of the following tumor types:
✓. Archival tumor tissue evaluable for ATM expression by immunohistochemistry (IHC)

Exclusion criteria

What they're measuring

Objective response rate (ORR) (ARID1A cohort)

Timeframe: Up to 3 years

Composite Prostate Cancer Patient Response Rate (prostate cancer only)

Timeframe: Up to 3 years

Objective response rate (ORR) for other solid tumors

Timeframe: Up to 3 years

Objective response rate (ORR) for endometrial cohort

Timeframe: Up to 3 years