Decorative dot pattern background image.
Decorative blue shape background image. Decorative blue shape background image. Decorative blue shape background image. Decorative blue shape background image.

A092104

Trial Overview

Official Title

A Randomized Phase 2/3 Study of Olaparib Plus Temozolomide Versus Investigator's Choice for the Treatment of Patients with Advanced Uterine Leiomyosarcoma After Progression on Prior Chemotherapy

Study Purpose

To compare the progression free survival (PFS)  and the overall survival (OS)of olaparib plus temozolomide (Arm 1) as compared to investigator’s choice (trabectedin or pazopanib) (Arm 2) for the treatment of patients with advanced uterine leiomyosarcoma who have received two or more prior lines of therapy as determined by investigator (local site) assessment.

Diagnosis

advanced uterine leiomyosarcoma (uLMS)

Eligibility

18 years of age or older

Patients must have had prior progression on, or intolerance to, at least two prior lines of systemic therapy for advanced uLMS

Intervention

 ARM 1 Olaparib + Temozolomide

 

ARM 2 Investigator’s Choice: Trabectedin or Pazopanib

For more information, visit ClinicalTrials.gov

Key Participation Requirements
Trial Location(s)
Methodist Estabrook Cancer Center Methodist Jennie Edmundson Hospital
Gender
Male or Female
Age
18 Years and older
Enrollment Status
Recruiting
Phase
Not Applicable