Phase 2 N=29 Treatment

Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

Sarcoma · Sarcoma Metastatic

Bottom Line

View on ClinicalTrials.gov: NCT04076579 ↗

Enrolled (actual)

Serious AEs

20.7%

Results posted

Jul 2024

Primary outcome: Primary: Overall Response Rate — 0; 2 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Olaparib (Drug); Trabectedin (Drug)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: University of Michigan Rogel Cancer Center
Primary completion: Jan 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Response Rate	0; 2	—
SECONDARY Progression Free Survival	8.9; 20.2	—
SECONDARY Progression Free Survival	8.9; 20.2	—
SECONDARY Overall Survival	0.52; 0.48; 0; 0.12	—
SECONDARY Incidence of Adverse Events	0; 1; 1; 3; 5; 1	—

Summary

This phase II trial studies how well trabectedin and olaparib work in treating patients with sarcoma that cannot be removed by surgery or has spread to other places in the body. Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing cells, stopping them from dividing or stopping them from spreading. Olaparib may stop the growth of tumor cells by blocking pathways responsible for repairing damaged cells. Giving trabectedin and olaparib may shrink or stop the tumor from growing.

Eligibility Criteria

Key Inclusion Criteria

Age ≥ 16 years
Advanced unresectable or metastatic sarcoma
Cohort 1: Leiomyosarcoma (LMS)/Liposarcoma (LPS)
Cohort 2: Other sarcoma histologies (excluding gastrointestinal stromal tumors)
Received at least 1 prior standard chemotherapy. For cohort 1 patients, this must have included a prior anthracycline.
Measurable disease by RECIST 1.1
Adequate hematologic, renal, hepatic function
Adequate creatine phosphokinase
ECOG performance status ≤ 1
Left ventricular ejection fraction (LVEF) >= institutional lower limit of normal (LLN)
Women of childbearing potential and men must agree to use adequate contraception from signing informed consent to at least 6 months (females) and 5 months (men) after study drug treatment

Key Exclusion Criteria

Prior therapy with PARP inhibitor, including olaparib
Prior therapy with trabectedin
Additional active malignancy or treatment for alternative cancer (excluding non-melanoma skin cancer) requiring treatment within the past two years
Pregnant or breastfeeding women
Known hypersensitivity to trabectedin or olaparib
Other exclusions per protocol

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04076579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.