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Trials in Progress

(P 562) A PHASE 2, SINGLE ARM STUDY OF REGORAFENIB IN METASTATIC/UNRESECTABLE REFRACTORY SYNOVIAL SARCOMAS

Location: The Liffey, Level 1

    Author(s)

  • Sanal Fernandes, MD (he/him/his)

    Senior Resident
    Department of Medical oncology, Dr BRAIRCH, All India Institute of Medical Sciences
    New Delhi, Delhi, India

    • Co-Author(s)

  • Sameer Rastogi, DM

    Addional Professor
    Department of medical oncology, Dr BRAIRCH, All India Institute of Medical Sciences
    New Delhi, Delhi, India

  • SS

    Shamim A. Shamim, MD

    Department of Nuclear Medicine, All India Institute of Medical Sciences
    New Delhi, Delhi, India

  • AB

    Adarsh Barwad, MD

    Department of Pathology, All India Institute of Medical Sciences
    New Delhi, Delhi, India

  • RP

    Rambha Pandey, MD

    Dr
    AIIMS
    New Delhi, Delhi, India

Objective: Treatment options in advanced synovial sarcomas remain scarce. The VEGF pathway has been shown to drive proliferation in soft tissue sarcomas. This study aims to study the efficacy of the multikinase inhibitor regorafenib in advanced synovial sarcomas.

Methods:

Methods:

Design: This a phase 2, Simon two-stage optimal design study

Sample size: 25 patients

Study centre: Dept of Medical Oncology, AIIMS, New Delhi, India
National Cancer Institute, Haryana

Study period: January 2022 to December 2023 with an additional one-year follow-up period

Participants: The study participants will include patients ≥16 years, with advanced synovial sarcomas and ECOG PS 0-2, that have progressed on two previous lines of therapy (one line being an anthracycline).

Intervention: Tablet regorafenib will be administered orally daily at a dose of 80 mg/ 120 mg on alternate days for a period of 3 months. Two sequential dose modifications will be allowed in case of grade 3 or higher toxicities.

Assessment:
Response assessment using RECIST 1.1 criteria will be undertaken at the end of 3 months. Patients who have not progressed at 3 months will be continued on the drug till clinical/ radiological progression with assessment every 3 months.
Toxicity evaluation using CTCAE v 5.0 will be done at monthly intervals. Quality of life assessment will be carried out at baseline and at 3 months using the EORTC QLQ C30 questionnaire.

End points:
Primary: 3-month progression-free rate
Secondary: a. PFS
b. OS
c. Overall response rate
d. Toxicity evaluation
e. Impact on quality of life

Results: N/A
The study has recruited 17 patients as of June 2023. Further accrual is ongoing.

Conclusion: NOT APPLICABLE