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

NCT03212937 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2021-04-28

No results posted yet for this study

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.

Conditions

  • Peripheral T-cell Lymphoma

Interventions

DRUG

Selinexor

Oral KPT-330 is administered on Day 3, 5, and 7 of each 21-day cycle. Starting dose is 40mg will be adjusted according to toxicity

DRUG

ICE Chemotherapy

IV Ifosfamide 5g/m\^2 on Day 2 (inpatient) or D1 (outpatient) of each 21-day cycle IV Carboplatin AUC 5 on Day 2 (inpatient) or D1-3 (outpatient) of each 21-day cycle IV Etoposide 100 mg/m\^2 on Days 1-3 of each 21-day cycle

Sponsors & Collaborators

  • National Cancer Centre, Singapore

    lead OTHER

Principal Investigators

  • Tiffany PL Tang · National Cancer Centre, Singapore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-01
Primary Completion
2020-11-30
Completion
2020-11-30

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03212937 on ClinicalTrials.gov