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Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

Sponsor
University of Michigan Rogel Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04076579
Collaborator
Janssen Scientific Affairs, LLC (Industry), AstraZeneca (Industry)
53
Enrollment
1
Location
1
Arm
35.4
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
53 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Multi-Center Trial of Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma
Actual Study Start Date :
Mar 17, 2020
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Olaparib + Trabectedin

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.

Drug: Olaparib
Olaparib taken by mouth twice daily

Drug: Trabectedin
Trabectedin administered intravenously (IV) every 21 days

Outcome Measures

Primary Outcome Measures

  1. Overall response rate [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.

Secondary Outcome Measures

  1. Progression free survival [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.

  2. Progression free survival [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.

  3. Overall survival [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.

  4. Incidence of adverse events [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan Rogel Cancer Center Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • University of Michigan Rogel Cancer Center
  • Janssen Scientific Affairs, LLC
  • AstraZeneca

Investigators

  • Principal Investigator: Rashmi Chugh, M.D., University of Michigan Rogel Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier:
NCT04076579
Other Study ID Numbers:
  • UMCC 2018.132
  • HUM00161251
First Posted:
Sep 3, 2019
Last Update Posted:
Dec 16, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Sarcoma
Olaparib
Trabectedin

Study Results

No Results Posted as of Dec 16, 2021