Ceralasertib (AZD6738) Alone and in Combination With Olaparib or Durvalumab in Patients With Soli… (NCT03682289) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
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):
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate (ORR) (ARID1A cohort)
Timeframe: Up to 3 years
2
Composite Prostate Cancer Patient Response Rate (prostate cancer only)
Timeframe: Up to 3 years
3
Objective response rate (ORR) for other solid tumors
Timeframe: Up to 3 years
4
Objective response rate (ORR) for endometrial cohort
. 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
. History of secondary malignancy requiring treatment within 1 year prior to screening, with the exception of carcinoma in situ of the cervix, non-melanoma skin carcinoma, low/intermediate risk localized prostate cancer (=\< Gleason 7, =\< T2N0M0, and prostate-specific antigen (PSA) =\< 20 ng/mL at diagnosis) (not applicable for prostate cancer cohort), ductal carcinoma in situ, Stage I uterine cancer, and non-muscle invasive urothelial carcinoma
. Patients receiving, or having received within 14 days of C1D1, corticosteroids at a dose \> 10 mg/day of prednisone (or equivalent).
. Patients with myelodysplastic syndrome or features suggestive of myelodysplastic syndrome.
. Prior treatment with ATR inhibitor
. Major surgical procedures \< 28 days prior to C1D1. Patients must have recovered to grade =\< 1 for any adverse events related to the surgical procedure.
. Untreated central nervous system (CNS) metastases. Patients with previously treated central nervous system (CNS) metastases are eligible if:
. Clinically significant gastrointestinal abnormalities that may increase the risk of decreased absorption of medications, including:
. Fridericia's QT correction formula (QTcF) \> 470 ms (females) or \> 450 ms (males) on screening electrocardiography (ECG), or immediate family history of congenital long QT syndrome or sudden cardiac death at age less than 40.