Clinical Trials /

Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

NCT04076579

Description:

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.

Related Conditions:
  • Leiomyosarcoma
  • Liposarcoma
  • Sarcoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma
  • Official Title: Phase II Multi-Center Trial of Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

Clinical Trial IDs

  • ORG STUDY ID: UMCC 2018.132
  • SECONDARY ID: HUM00161251
  • NCT ID: NCT04076579

Conditions

  • Sarcoma
  • Sarcoma Metastatic

Interventions

DrugSynonymsArms
OlaparibOlaparib + Trabectedin
TrabectedinOlaparib + Trabectedin

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Olaparib + TrabectedinExperimentalThere 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.
  • Olaparib
  • Trabectedin

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:16 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate
Time Frame:Up to 2 years
Safety Issue:
Description:Percentage of participants with complete or partial response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, within each cohort.

Secondary Outcome Measures

Measure:Progression free survival
Time Frame:At 6 months
Safety Issue:
Description: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.
Measure:Progression free survival
Time Frame:At approximately 2 years after enrollment
Safety Issue:
Description: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.
Measure:Overall survival
Time Frame:At approximately 2 years after enrollment
Safety Issue:
Description:Calculated by the Kaplan-Meier method with errors according to Peto, within each cohort. Median, 1- and 2-year OS will be estimated along with their 95% confidence intervals.
Measure:Incidence of adverse events
Time Frame:Up to 30 days after end of treatment
Safety Issue:
Description: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.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:University of Michigan Rogel Cancer Center

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