Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

University of Michigan Rogel Cancer Center29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sarcoma Sarcoma Metastatic

Interventions

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Overall Response Rate

Percentage of participants with complete or partial response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, within each cohort.

Time frame: Up to 2 years

Secondary Outcomes

Progression Free Survival

Defined as the duration of time from start of treatment to time of progression. Calculated by the Kaplan-Meier method with errors according to Peto, within each cohort. Median and 6-month PFS will be estimated along with their 95% confidence intervals.

Time frame: At 6 months

Progression Free Survival

Defined as the duration of time from start of treatment to time of progression. Calculated by the Kaplan-Meier method with errors according to Peto, within each cohort. reported as survival probability estimates

Time frame: At 1 year after enrollment

Overall Survival

Calculated by the Kaplan-Meier method with errors according to Peto, within each cohort. Median, 1- and 2-year OS probability estimates will be estimated along with their 95% confidence intervals.

Time frame: At 2 years after enrollment

Incidence of Adverse Events

The frequency and rates of adverse events occurring in at least 5% of participants and rates of grade 3-5 adverse events will be tabulated by system organ class and preferred term using Common Terminology Criteria of Adverse Events (CTCAE), within each cohort.

Time frame: Up to 30 days after end of treatment, and average of 4.5 months