Arm 1 (olaparib, temozolomide) for Uterine Leiomyosarcoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Uterine Leiomyosarcoma+5 MoreOlaparib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase II/III trial compares the effect of the combination of olaparib and temozolomide to the usual treatment (trabectedin and pazopanib) for uterine leiomyosarcoma that has spread to other places in the body (advanced) after initial chemotherapy has stopped working. Olaparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Temozolomide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of tumor cells in the body. The combination of olaparib and temozolomide may work better than the usual treatment in shrinking or stabilizing advanced uterine leiomyosarcoma after initial chemotherapy has stopped working.

Eligible Conditions
  • Uterine Leiomyosarcoma
  • Metastatic Leiomyosarcoma
  • Uterine Corpus Leiomyosarcoma
  • Unresectable Leiomyosarcoma
  • Leiomyosarcoma

Treatment Effectiveness

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Up to 5 years

Year 5
Overall survival (OS) (Phase III)
Year 5
Progression free survival (PFS) (Phase II)
Year 5
Duration of response (DOR)
Week 4
Incidence of adverse events
Up to 5 years
Overall response rate (ORR)
Up to 6 weeks
Disease control rate (DCR)
Day 60
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 Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Arm 2 (trabectedin, pazopanib)
1 of 2
Arm 1 (olaparib, temozolomide)
1 of 2

Active Control

Experimental Treatment

70 Total Participants · 2 Treatment Groups

Primary Treatment: Arm 1 (olaparib, temozolomide) · No Placebo Group · Phase 2 & 3

Arm 1 (olaparib, temozolomide)Experimental Group · 2 Interventions: Olaparib, Temozolomide · Intervention Types: Drug, Drug
Arm 2 (trabectedin, pazopanib)ActiveComparator Group · 2 Interventions: Trabectedin, Pazopanib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2017
Completed Phase 4
~2090
Temozolomide
2010
Completed Phase 3
~1940

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,098 Previous Clinical Trials
41,145,787 Total Patients Enrolled
4 Trials studying Uterine Leiomyosarcoma
271 Patients Enrolled for Uterine Leiomyosarcoma
Alliance for Clinical Trials in OncologyLead Sponsor
505 Previous Clinical Trials
217,268 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are of childbearing potential, and a negative pregnancy test done ≤ 7 days prior to registration is required.
You have metastatic or locally advanced and surgically unresectable disease, in the opinion of the treating investigator.
Patients must have at least one lesion that is measurable per RECIST version (v)1.1 to be eligible for the study.
You must have completed all prior anti-cancer treatment, including radiation, =< 28 days prior to registration.