Back to resultsTrabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma
Primary Purpose
Sarcoma, Sarcoma Metastatic
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Olaparib
Trabectedin
Sponsored by
About this trial
This is an interventional treatment trial for Sarcoma
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
Sites / Locations
- University of Michigan Rogel Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Olaparib + Trabectedin
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT04076579
First Posted
August 29, 2019
Last Updated
August 30, 2023
Sponsor
University of Michigan Rogel Cancer Center
Collaborators
Janssen Scientific Affairs, LLC, AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT04076579
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 17, 2020 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
Collaborators
Janssen Scientific Affairs, LLC, AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Sarcoma Metastatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Olaparib + Trabectedin
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Olaparib
Intervention Description
Olaparib taken by mouth twice daily
Intervention Type
Drug
Intervention Name(s)
Trabectedin
Intervention Description
Trabectedin administered intravenously (IV) every 21 days
Primary Outcome Measure Information:
Title
Overall response rate
Description
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 Outcome Measure Information:
Title
Progression free survival
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.
Time Frame
At 6 months
Title
Progression free survival
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.
Time Frame
At approximately 2 years after enrollment
Title
Overall survival
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.
Time Frame
At approximately 2 years after enrollment
Title
Incidence of adverse events
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.
Time Frame
Up to 30 days after end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rashmi Chugh, M.D.
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Rogel Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma
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