Status:
COMPLETED
A Study of Different Dosing Schedules of Selinexor in Sarcoma Patients
Lead Sponsor:
University Health Network, Toronto
Conditions:
Soft Tissue Sarcoma
Malignant Peripheral Nerve Sheath Tumor (MPNST)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Detailed Description
Background: Soft tissue sarcomas (STS): STS are a group of heterogeneous mesenchymal derived tumors with many histological types that account for approximately 1% of adult tumors and 15% of pediatri...
Eligibility Criteria
Inclusion
- Written informed consent in accordance with federal, local, and institutional guidelines
- Age \> 18 years.
- Patients must have histologically confirmed locally advanced/unresectable or metastatic STS
- For Arm A the acceptable histologies are MPNST, ESS and LMS
- For Arm B arm all STS histologies are eligible
- Patients must fall into one of the three following categories:
- Show evidence of progressive disease on study entry; or
- Be treatment naïve, but have progressed since diagnosis; or
- Newly diagnosed patients with de novo metastatic measurable disease.
- Patient must have measureable disease as defined by RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Adequate hematopoietic function within 7 days prior to C1D1:
- absolute neutrophil count (ANC) ≥1.0x109/L
- hemoglobin ≥ 90 g/L
- platelet count ≥100 x 109/L
- Patients receiving hematopoietic growth factor support, including erythropoietin, darbepoetin, granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), and platelet stimulators (eg, eltrombopag, romiplostim, or interleukin-11) must have a 2-week interval between growth factor support and the Screening assessments, but they may receive growth factor support during the study.
- Patients must have:
- i. At least a 2-week interval from the last red blood cell (RBC) transfusion prior to the Screening hemoglobin assessment, and
- ii. At least a 1-week interval from the last platelet transfusion prior to the Screening platelet assessment.
- iii. However, patients may receive RBC and/or platelet transfusions as clinically indicated per institutional guidelines during the study.
- Adequate hepatic function within 28 days prior to C1D1:
- Bilirubin \<1.5 times the upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of \< 3 times ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<2 X ULN. In the case of known (radiological and/or biopsy documented) liver metastasis, ALT/AST \<5.0 X ULN is acceptable;
- Adequate renal function within 28 days prior to C1D1: estimated creatinine clearance of ≥20 mL/min calculated using the formula of Cockcroft and Gault: (140-Age)(Weight in kg)(Constant)/(serum creatinine µmol/L); where constant is 1.23 for men and by 1.04 for women.
- Female patients of childbearing potential must agree to use two methods of contraception (including one highly effective and one effective method of contraception) and have a negative serum pregnancy test at Screening. Male patients must use an effective barrier method of contraception if sexually active with a female of childbearing potential. For both male and female patients, effective methods of contraception must be used throughout the study and for 3 months following the last dose of study treatment.
- Ability to swallow pills
Exclusion
- Has received selinexor or another XPO1 inhibitor previously
- Patients who are pregnant or lactating
- Radiation (except planned or on-going palliative radiation outside of the region of measurable disease), chemotherapy, immunotherapy, any other systemic anticancer therapy, or participation in an investigational anti-cancer study ≤3 weeks prior to initiation of therapy. Mitomycin C and radio-immunotherapy within 6 weeks prior to cycle 1 day 1.
- Major surgery within 4 weeks before initiation of therapy
- Active, ongoing or uncontrolled active infection within one week prior to first dose
- Patients with any gastrointestinal dysfunctions that could interfere with the absorption of Selinexor or patients with significantly diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea;
- Inability or unwillingness to take supportive medications such as anti-nausea and anti anorexia agents as recommended by the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Antiemesis and Palliative Care.
- In the opinion of the Investigator, patients who are significantly below their ideal body weight (Body Surface Area ≤ 1.2m2)
- Concurrent therapy with approved or investigational anticancer therapeutic agents
- Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study regimen or interpretation of patient safety or study results
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2025
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04811196
Start Date
March 29 2021
End Date
May 15 2025
Last Update
May 29 2025
Active Locations (1)
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1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9