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PARP inhibitor

Arm 1 (olaparib, temozolomide) for Uterine Leiomyosarcoma

Q: Are there any ongoing opportunities for patients to enroll in this clinical trial?

According to the information available on clinicaltrials.gov, this study is presently seeking eligible participants. The trial was initially posted on March 30th, 2023 and underwent its most recent update on December 20th, 2023.

Q: At how many distinct sites is the management of this study taking place?

At present, there are 139 sites actively enrolling patients for this trial. These sites are spread across various locations including Deerfield Beach, Irvine, DeKalb, and many others. It is recommended that participants choose a site closest to their location in order to minimize travel obligations during the study.

Q: What is the overall count of individuals involved in this clinical research?

In order to conduct this trial, a total of 190 eligible participants are needed. Potential patients have the option to participate from various locations, including UM Sylvester Comprehensive <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center at Deerfield Beach in Deerfield Beach, <a href="https://www.withpower.com/clinical-trials/florida">Florida</a> and City of Hope at Irvine Lennar in Irvine, <a href="https://www.withpower.com/clinical-trials/california">California</a>.

Phase 2 & 3

Recruiting

Led By Brian Van Tine

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall survival (OS) (Phase III)

Progression free survival (PFS) (Phase II)

Secondary outcome measures

Disease control rate

Duration of response (DOR)

Incidence of adverse events

+1 more

Other outcome measures

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

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

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Olaparib

2007

Completed Phase 4

~2140

Transthoracic Echocardiography

2016

N/A

~360

Biospecimen Collection

2004

Completed Phase 2

~1700

Temozolomide

2010

Completed Phase 3

~1930

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,672 Previous Clinical Trials

40,926,251 Total Patients Enrolled

4 Trials studying Uterine Leiomyosarcoma

271 Patients Enrolled for Uterine Leiomyosarcoma

Brian Van TinePrincipal InvestigatorAlliance for Clinical Trials in Oncology

2 Previous Clinical Trials

64 Total Patients Enrolled

Matthew InghamPrincipal InvestigatorAlliance for Clinical Trials in Oncology

3 Previous Clinical Trials

96 Total Patients Enrolled

Frequently Asked Questions

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

Are there any ongoing opportunities for patients to enroll in this clinical trial?

"According to the information available on clinicaltrials.gov, this study is presently seeking eligible participants. The trial was initially posted on March 30th, 2023 and underwent its most recent update on December 20th, 2023."

Answered by AI

At how many distinct sites is the management of this study taking place?

"At present, there are 139 sites actively enrolling patients for this trial. These sites are spread across various locations including Deerfield Beach, Irvine, DeKalb, and many others. It is recommended that participants choose a site closest to their location in order to minimize travel obligations during the study."

Answered by AI

What is the overall count of individuals involved in this clinical research?

"In order to conduct this trial, a total of 190 eligible participants are needed. Potential patients have the option to participate from various locations, including UM Sylvester Comprehensive Cancer Center at Deerfield Beach in Deerfield Beach, Florida and City of Hope at Irvine Lennar in Irvine, California."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working

2023. "Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05432791.

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