drugset
drugset / Trial / NCT03212937

Phase I Trial of Selinexor (KPT-330) and Ifosfamide, Carboplatin, Etoposide (ICE) in Peripheral T-cell Lymphoma

NCT03212937 ↗

Phase 1 Completed 11 enrolled National Cancer Centre, Singapore
NaSingle-groupOpen-labelTreatment

Summary

This is a single center, open-label, phase I trial with a standard 3+3 dose escalation schema to identify the maximum tolerated dose (MTD) of selinexor when combined with ICE. Once MTD is determined, there will be an expansion phase and tumor biopsies and peripheral blood will be taken pre and post selinexor to examine the study's biologic objectives.

Timeline

Start
2016-07-01
Primary completion
2020-11
Completion
2020-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Selinexor Other / unclassified 20 mg Oral
Subject Selinexor Other / unclassified 40 mg Oral
Subject Selinexor Other / unclassified 60 mg Oral
Subject Selinexor Other / unclassified 80 mg Oral
Background Etoposide Small molecule 100 mg/m2 Intravenous
Background ICE Chemotherapy Unknown 5 unknown —
Background Ifosfamide Small molecule 5 g Intravenous

Indications

peripheral T-cell lymphoma, not otherwise specified