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ATR Kinase Inhibitor

Ceralasertib + Olaparib/Durvalumab for Cancer

Phase 2
Recruiting
Led By Rahul Aggarwal, MD
Research Sponsored by Rahul Aggarwal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Endometrial Cancer Cohort: Histologically confirmed endometrial cancer with specific genetic alteration requirements and disease measurement criteria
ARID1A Subgroup: Histologically confirmed locally advanced or metastatic solid tumor malignancy with progression on at least one prior systemic therapy, including specific tumor types and requirements for tumor tissue evaluation and disease measurement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing a new drug to see if it works better than current treatments for solid tumors.

Who is the study for?
This trial is for adults with advanced or metastatic solid tumors, including kidney, pancreatic, endometrial and prostate cancers. Participants must have progressed on prior therapy and have measurable disease. They need adequate organ function, available tumor tissue samples, and must agree to use effective contraception.Check my eligibility
What is being tested?
The study tests the effectiveness of Ceralasertib alone or combined with Olaparib or Durvalumab in treating various solid tumors. It aims to see if blocking certain enzymes needed for cell growth can control tumor progression better than current treatments.See study design
What are the potential side effects?
Potential side effects may include fatigue, nausea, skin reactions at the injection site for Durvalumab, anemia from Olaparib, as well as possible liver enzyme changes due to Ceralasertib. The severity of side effects varies among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My endometrial cancer has been confirmed with specific genetic changes.
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My cancer has spread, worsened after treatment, and requires specific tissue tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite Prostate Cancer Patient Response Rate (prostate cancer only)
Objective response rate (ORR) (ARID1A cohort)
Objective response rate (ORR) for endometrial cohort
+1 more
Secondary outcome measures
Median Overall Survival (Endometrial cohort only)
Median duration of response (DOR) by disease group
Median duration of response (DOR) by treatment regimen
+9 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm III (Ceralasertib, Durvalumab)Experimental Treatment2 Interventions
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.
Group II: Arm II (Ceralasertib, Olaparib)Experimental Treatment2 Interventions
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.
Group III: Arm I (Ceralasertib Monotherapy)Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceralasertib
2017
Completed Phase 1
~30
Olaparib
2007
Completed Phase 4
~2140
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

Rahul AggarwalLead Sponsor
11 Previous Clinical Trials
431 Total Patients Enrolled
7 Trials studying Prostate Cancer
278 Patients Enrolled for Prostate Cancer
AstraZenecaIndustry Sponsor
4,243 Previous Clinical Trials
288,527,683 Total Patients Enrolled
60 Trials studying Prostate Cancer
27,522 Patients Enrolled for Prostate Cancer
Rahul Aggarwal, MDPrincipal Investigator - University of California, San Francisco
UCSF Medical Center at Parnassus
Northwestern University Medical Sch (Medical School)
22 Previous Clinical Trials
1,321 Total Patients Enrolled
13 Trials studying Prostate Cancer
1,043 Patients Enrolled for Prostate Cancer

Media Library

ATR Kinase Inhibitor AZD6738 (ATR Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03682289 — Phase 2
Prostate Cancer Research Study Groups: Arm III (Ceralasertib, Durvalumab), Arm I (Ceralasertib Monotherapy), Arm II (Ceralasertib, Olaparib)
Prostate Cancer Clinical Trial 2023: ATR Kinase Inhibitor AZD6738 Highlights & Side Effects. Trial Name: NCT03682289 — Phase 2
ATR Kinase Inhibitor AZD6738 (ATR Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03682289 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what medical application is ATR Kinase Inhibitor AZD6738 most frequently used?

"ATR Kinase Inhibitor AZD6738 is a therapeutic option commonly used after chemotherapy. Additionally, it can be prescribed to address myocardial scintigraphy, coronary artery disease (CAD), and lack of physical activity."

Answered by AI

What objectives does this research endeavor hope to accomplish?

"This clinical trial will span up to 2.5 years and evaluate Composite [Prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) Patient Response Rate as its primary outcome measure. Secondary endpoints encompass the calculation of Progression-free survival (PFS) rate over time, Number of treatment-related adverse events (AEs), and an assessment of Prostate Cancer Patient Response Rate using PCWG3 criteria for PSA50 response rate."

Answered by AI

What is the aggregate number of participants involved in this investigation?

"Affirmative. As evidenced on clinicaltrials.gov, this medical research was first posted to the public record on January 17th 2019 and has been actively recruiting since then. Currently, 59 patients are needed from one site for enrollment in the trial."

Answered by AI

Is this the inaugural research of its kind?

"Since 2005, the ATR Kinase Inhibitor AZD6738 has been under investigation. Initially sponsored by AstraZeneca in a 98-subject study, this drug achieved Phase 1 approval shortly afterwards and today there are 208 active trials taking place across 1472 cities and 59 nations."

Answered by AI

Has there been any prior research on the efficacy of ATR Kinase Inhibitor AZD6738?

"Currently, there are 208 clinical trials researching ATR Kinase Inhibitor AZD6738. Of these active studies, 28 have entered the Phase 3 stage of development. Although most tests for this treatment take place in Houston Texas, 9421 other sites across the world are offering trial participants access to ATR Kinase Inhibitor AZD6738."

Answered by AI

Has regulatory approval been granted to utilize ATR Kinase Inhibitor AZD6738?

"Although ATR-Kinase Inhibitor AZD6738 is still in Phase 2, which means there is limited evidence backing its efficacy and some supportive of safety, the Power team has rated it a score of 2."

Answered by AI

Are there still open slots available to join this clinical experiment?

"Affirmative. Information provided on clinicaltrials.gov states that this investigation is currently seeking participants, having been made available since January 17th 2019 and last updated July 7th 2022. 59 eligible patients need to be enrolled across a single clinical site."

Answered by AI
~18 spots leftby Jul 2025