- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04076579
Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma
August 30, 2023 updated by: University of Michigan Rogel Cancer Center
Phase II Multi-Center Trial of Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma
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 Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan Rogel Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Olaparib + Trabectedin
There are 2 cohorts. Both cohorts receive the same treatment:
Treatment consists of 21-day cycles for a maximum of 18 months. |
Olaparib taken by mouth twice daily
Trabectedin administered intravenously (IV) every 21 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate
Time Frame: Up to 2 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: At 6 months
|
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
|
Progression free survival
Time Frame: At approximately 2 years after enrollment
|
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
|
Overall survival
Time Frame: At approximately 2 years after enrollment
|
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
|
Incidence of adverse events
Time Frame: Up to 30 days after end of treatment
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Rashmi Chugh, M.D., University of Michigan Rogel Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 17, 2020
Primary Completion (Actual)
January 30, 2023
Study Completion (Estimated)
January 1, 2025
Study Registration Dates
First Submitted
August 29, 2019
First Submitted That Met QC Criteria
August 29, 2019
First Posted (Actual)
September 3, 2019
Study Record Updates
Last Update Posted (Estimated)
August 31, 2023
Last Update Submitted That Met QC Criteria
August 30, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMCC 2018.132
- HUM00161251 (Other Identifier: University of Michigan)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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