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ATR Kinase Inhibitor

Olaparib + Ceralasertib for Cancer

Phase 2

Waitlist Available

Led By Patricia M LoRusso

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing olaparib and ceralasertib in patients with specific genetic mutations in their cancer. The drugs work by stopping cancer cells from repairing themselves and growing. The goal is to see if this combination can be more effective for these hard-to-treat cancers. Olaparib has been approved for use in various cancers, including ovarian and breast cancer.

Who is the study for?

This trial is for adults (18+) with IDH1 or IDH2 mutant cholangiocarcinoma or solid tumors that have progressed despite standard therapy, or no effective therapy exists. Participants must be willing to provide tissue samples and undergo extra blood sampling. They should not have severe chronic health issues, uncontrolled infections, or a history of certain heart conditions. Women must use contraception, and men agree to prevent partner pregnancy.

What is being tested?

The phase II trial tests the effectiveness of olaparib and ceralasertib in treating patients with specific gene mutations in their tumors. These drugs may block enzymes needed for tumor cell growth. The study involves computed tomography, biopsies, bone marrow aspirations, and MRI scans to monitor treatment effects.

What are the potential side effects?

Potential side effects include nausea, vomiting, fatigue, anemia (low red blood cells), low white blood cell count increasing infection risk; organ-specific inflammation; allergic reactions; potential impact on fertility; and other non-specified drug-related adverse events.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate (ORR)

Secondary study objectives

Duration of response

Incidence of adverse events

Overall survival (OS)

+1 more

Other study objectives

2HG levels

Absolute and fold changes in gamma H2AX foci

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (olaparib, ceralasertib)Experimental Treatment8 Interventions

Patients receive olaparib PO BID on days 1-28 of each cycle and ceralasertib PO QD on days 1-7 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo tumor biopsies during screening and on study, collection of blood samples throughout the trial, and undergo CT and/or MRI scans throughout the trial. Patients may also undergo bone marrow aspiration and biopsy as clinically indicated on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2740

Biopsy

2014

Completed Phase 4

~1090