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

Sponsor
National Cancer Centre, Singapore
Study ID
NCT03212937
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    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
  • ICE Chemotherapy — DRUG
    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

Study Details

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.

Key Dates

Start date
Jul 1, 2016
Status verified
Apr 2021
Primary completion
Nov 30, 2020
Completion
Nov 30, 2020

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Selinexor and ICE Chemotherapy

Primary Outcome Measure

Number of participants with treatment related dose limiting toxicity as assessed by NCI CTCAE v4.0 [ Time Frame: The first 3 weeks of treatment ]

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