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PARP inhibitor

Olaparib + Temozolomide for Uterine Leiomyosarcoma

Phase 2 & 3

Recruiting

Research Sponsored by Alliance for Clinical Trials in Oncology

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 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial compares using a PARP inhibitor and alkylating agent to usual treatment for advanced uterine leiomyosarcoma after chemotherapy. The combo may be more effective.

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 no major organ dysfunction, not be pregnant or breastfeeding, and cannot have had certain other cancers or severe illnesses that could interfere with the study.

What is being tested?

The trial compares a new combination of drugs (Olaparib and Temozolomide) against standard treatments (Trabectedin and Pazopanib) to see if they are more effective in shrinking or stabilizing this type of cancer after previous chemotherapy has failed.

What are the potential side effects?

Possible side effects include nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, liver function alterations, and potential allergic reactions. The severity can vary from mild to serious.

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 (DCR)

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 Treatment2 Interventions

Patients receive temozolomide is administered at 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

Group II: Arm 2 (trabectedin, pazopanib)Active Control2 Interventions

Patients receive trabectedin IV continuously over 24 hours on day 1 of each cycle and pazopanib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olaparib

2007

Completed Phase 4

~2190

Temozolomide

2010

Completed Phase 3

~1880