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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04076579
Other study ID # UMCC 2018.132
Secondary ID HUM00161251
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date March 17, 2020
Est. completion date January 2025

Study information

Verified date August 2023
Source University of Michigan Rogel Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 29
Est. completion date January 2025
Est. primary completion date January 30, 2023
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Olaparib
Olaparib taken by mouth twice daily
Trabectedin
Trabectedin administered intravenously (IV) every 21 days

Locations

Country Name City State
United States University of Michigan Rogel Cancer Center Ann Arbor Michigan

Sponsors (3)

Lead Sponsor Collaborator
University of Michigan Rogel Cancer Center AstraZeneca, Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 2 years
Secondary 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. At 6 months
Secondary 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. At approximately 2 years after enrollment
Secondary Overall survival 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. At approximately 2 years after enrollment
Secondary 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. Up to 30 days after end of treatment
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