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ATR Kinase Inhibitor

Olaparib + Ceralasertib for Recurrent Osteosarcoma

Phase 2

Recruiting

Led By Katherine Janeway, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

Participants with pulmonary disease on only one side must have archival tumor specimen available for submission

Weight > 40 kg

Must not have

Concomitant use of known potent CYP3A inducers

Any unresolved toxicities from prior therapy ≥ Common Terminology Criteria for Adverse Events (CTCAE) grade 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from registration until death from any cause up to 4 years

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is being done to see if using these two drugs together can help patients with osteosarcoma who haven't responded to other treatments, or whose cancer has returned after treatment.

Who is the study for?

This trial is for people aged 12-40 with osteosarcoma that has returned or didn't respond to treatment. They must weigh over 40 kg, have a life expectancy of at least 16 weeks, and be able to swallow pills. Women must not be pregnant or breastfeeding and use effective contraception. Men should also use barrier contraception.

What is being tested?

The effectiveness of two drugs, Olaparib and Ceralasertib, is being tested on patients with recurrent osteosarcoma. The study aims to see how well these drugs work when other treatments have failed or the cancer has come back.

What are the potential side effects?

Possible side effects include blood disorders (like changes in white blood cells), fatigue, nausea, vomiting, diarrhea, loss of appetite, joint/muscle pain; risk of infection may increase due to lowered immune response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have lung disease on one side and can provide a sample of my tumor.

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I weigh more than 40 kg.

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I am between 13 and 40 years old.

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Surgery for my disease is not possible without major risks and no other standard treatments are available.

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I am mostly active and can care for myself, with no recent decline.

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My kidney, liver, and bone marrow are functioning normally.

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My osteosarcoma was confirmed through tissue examination.

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My lung cancer has come back at least once but is still only in my lungs.

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My condition has not improved or has worsened despite treatment.

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I have recovered from side effects of my previous cancer treatments.

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I can swallow pills whole.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any strong CYP3A enzyme stimulators.

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I don't have any lasting side effects from previous treatments that are moderate or worse.

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I have not had heart disease in the past 6 months.

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I do not have any uncontrolled illnesses like heart failure or severe infections.

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I am not taking strong or moderate drugs that affect liver enzymes.

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I have been diagnosed with ataxia telangiectasia.

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My heart's pumping ability is below normal.

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I have not had immunotherapy in the last 42 days.

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I have been diagnosed with MDS, AML, or have symptoms suggesting these conditions.

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I have not had major surgery in the last 2 weeks.

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I am not pregnant or breastfeeding.

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I am not using effective birth control.

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I plan to use herbal medications within a week before starting the study treatment.

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I have ongoing issues with nausea, vomiting, or have had major surgery on my intestines.

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I have brain metastases that are causing symptoms and are not under control.

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I experience significant drops in blood pressure when standing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from registration until death from any cause up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from registration until death from any cause up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from registration until death from any cause up to 4 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Cohort 1 Event Free at 4 months

Cohort 2 paired pre-/post-treatment tumor Assessment

Secondary study objectives

Cohort 2 Event Free Survival 12 months

Event Free Survival

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0

+2 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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: Olaparib-CeralasertibExperimental Treatment2 Interventions

Unresectable disease (can not be surgically removed) will be enrolled into Cohort 1 and Resectable disease (can be surgically removed) which is limited only to the lung parenchyma will be enrolled into Cohort 2. * Olaparib at a predetermined dose orally 2 times a day on days 1-28 * Ceralasertib will be given at a predetermined dose orally 2 times a day on days 1-14 in 28-day study cycles. Patients can remain on treatment for up to 2 years if disease progression has not occurred.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olaparib

FDA approved

Ceralasertib

Not yet FDA approved

0 / 27Eligibility criteria met