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PARP inhibitor

Olaparib + Temozolomide for Uterine Leiomyosarcoma

Phase 2 & 3

Waitlist Available

Led By Matthew Ingham

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

ECOG Performance Status =< 2

No uncontrolled ventricular arrhythmia or recent myocardial infarction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing the effectiveness of a combination treatment using olaparib and temozolomide to the common chemotherapy drugs trabectedin or pazopanib. The trial is for patients

Who is the study for?

This trial is for adults with advanced uterine leiomyosarcoma that has worsened after at least two prior treatments, including an anthracycline. Participants must have measurable disease, be in relatively good health (ECOG <=2), and women must test negative for pregnancy. Those with significant treatment-related side effects or who haven't recovered from previous therapies are excluded.

What is being tested?

The study compares a new combination of drugs (Olaparib and Temozolomide) against standard chemotherapy options (Trabectedin or Pazopanib) for advanced uterine leiomyosarcoma post-initial chemo failure. Olaparib may prevent tumor DNA repair, while Temozolomide aims to slow tumor growth.

What are the potential side effects?

Possible side effects include nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, hair loss which is usually temporary, digestive issues like constipation or diarrhea, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself but might not be able to do heavy physical work.

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I don't have uncontrolled heart rhythm problems or recent heart attacks.

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I have tried at least two treatments for advanced uLMS without success or could not tolerate them.

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I finished my last cancer treatment at least 28 days ago.

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My cancer is a type of uterine sarcoma known as leiomyosarcoma.

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My cancer has spread and cannot be removed with surgery.

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My high blood pressure is under control.

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I have never had myelodysplastic syndrome or acute myeloid leukemia.

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I am 18 years old or older.

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My hepatitis B virus is undetectable with current treatment.

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My hepatitis C is cured or currently undetectable.

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I am not taking any strong medications that affect liver enzymes.

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I do not have any untreated or uncontrolled illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Overall survival (OS) (Phase III)

Progression free survival (PFS) (Phase II)

Secondary study objectives

Disease control rate

Duration of response (DOR)

Incidence of adverse events

+1 more

Other study objectives

Proportion of patients with a genomic alteration in a homologous recombination (HR) pathway gene

Relationship between the presence of an alteration in HR pathway genes and clinical benefit from olaparib and temozolomide

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1 (olaparib, temozolomide)Experimental Treatment8 Interventions

Patients receive temozolomide PO QD on days 1-7 of each cycle and olaparib PO BID on days 1-7 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and/or bone scans throughout the trial. Patients also undergo collection of blood samples throughout the trial.

Group II: Arm 2 (trabectedin, pazopanib)Active Control8 Interventions

Patients receive trabectedin IV continuously over 24 hours on day 1 of each cycle or pazopanib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and/or bone scans throughout the trial. Patients also undergo TTE or MUGA on study and as clinically indicated, as well as collection of blood samples throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2030

Bone Scan

2015

Completed Phase 2

~50