Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

University of Michigan Rogel Cancer Center

Status and phase: Completed; Phase 2

Conditions: Sarcoma; Sarcoma Metastatic

Treatments: Drug: Trabectedin; Drug: Olaparib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04076579

UMCC 2018.132

HUM00161251 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Olaparib + Trabectedin

Experimental group

Description:

There are 2 cohorts. Both cohorts receive the same treatment: * Cohort 1: Leiomyosarcoma and liposarcoma * Cohort 2: Other bone or soft tissue sarcoma histologies Treatment consists of 21-day cycles for a maximum of 18 months.

Treatment:

Drug: Olaparib

Drug: Trabectedin