A Study of Different Dosing Schedules of Selinexor in Sarcoma Patients
Status:
Recruiting
Trial end date:
2025-02-01
Target enrollment:
Participant gender:
Summary
This is a phase 1, open-label, single centre study of investigational drug selinexor in
participants with soft tissue sarcomas that cannot be treated with standard therapies.
Selinexor has been given to 3111 participants with cancer to date including 142 sarcoma
patients. Early findings have shown that selinexor is effective in multiple cancer types. The
current study is being done to test low doses and different dosing schedules of selinexor to
find out if it reduces the side effects without compromising the benefits.
This study has 2 groups or Arms: Arm A and Arm B.
Arm A (Dose escalation Arm): Participants will receive selinexor by mouth 4 days a week to
find out the safety, tolerability and anti-tumor effect of low doses of Selinexor in
participants with advanced or metastatic malignant peripheral nerve sheath tumors (MPNST),
endometrial stromal sarcomas (ESS) and leiomyosarcoma (LMS). Participants will continue on
study until disease progression or unacceptable side effects. Up to 36 participants will be
enrolled in this Arm.
Arm B: Participants with any soft tissue sarcoma subtypes will be enrolled in this Arm. They
will receive flat doses of Selinexor by mouth once weekly, 3 times a day. Safety and
tolerability will be assessed in this Arm. Up to 20 participants will be enrolled and they
will continue to receive selinexor until disease progression or unacceptable side effects.
Cancer is the uncontrolled growth of human cells. One of the ways cancers cells continue to
grow is by getting rid of proteins called "tumor suppressor proteins" that would normally
cause cancer cells to die. The study drug works by trapping "tumor suppressor proteins"
within the cell, causing the cancer cells to die or stop growing.
The study comprises 3 periods: Screening (up to 28 days), Study Drug (until disease
progression), and Survival Follow-Up (once every 3 months). Procedures for research purposes
only will include blood collection and study questionnaire.