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.
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
Drug | Synonyms | Arms |
---|
Olaparib | | Olaparib + Trabectedin |
Trabectedin | | Olaparib + 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
Name | Type | Description | Interventions |
---|
Olaparib + Trabectedin | Experimental | 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. | |
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: | Recruiting |
Lead Sponsor: | University of Michigan Rogel Cancer Center |
Last Updated
May 5, 2020