Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

Sarcoma Clinical Trial

Official title:

Phase II Multi-Center Trial of Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

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
• 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
• 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

Related Conditions & MeSH terms

• Sarcoma
• Sarcoma Metastatic

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