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Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04076579
Recruitment Status : Recruiting
First Posted : September 3, 2019
Last Update Posted : December 16, 2021
Sponsor:
Collaborators:
Janssen Scientific Affairs, LLC
AstraZeneca
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

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
Sarcoma Sarcoma Metastatic Drug: Olaparib Drug: Trabectedin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 17, 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04076579


Locations
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United States, Michigan
University of Michigan Rogel Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Cancer AnswerLine    800-865-1125    CancerAnswerLine@med.umich.edu   
Principal Investigator: Rashmi Chugh, M.D.         
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Janssen Scientific Affairs, LLC
AstraZeneca
Investigators
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Principal Investigator: Rashmi Chugh, M.D. University of Michigan Rogel Cancer Center
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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT04076579    
Other Study ID Numbers: UMCC 2018.132
HUM00161251 ( Other Identifier: University of Michigan )
First Posted: September 3, 2019    Key Record Dates
Last Update Posted: December 16, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Olaparib
Trabectedin
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents