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Phase I Trial of Selinexor (KPT-330) and Ifosfamide, Carboplatin, Etoposide (ICE) in Peripheral T-cell Lymphoma - Trial NCT03212937

Access comprehensive clinical trial information for NCT03212937 through Pure Global AI's free database. This Phase 1 trial is sponsored by National Cancer Centre, Singapore and is currently Completed. The study focuses on Peripheral T-cell Lymphoma. Target enrollment is 11 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT03212937
Phase 1
Completed
drug
Trial Details
ClinicalTrials.gov โ€ข NCT03212937
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Phase I Trial of Selinexor (KPT-330) and Ifosfamide, Carboplatin, Etoposide (ICE) in Peripheral T-cell Lymphoma
A Phase I Investigator Sponsored Trial of Selinexor (KPT-330), a Selective Inhibitor of Nuclear Export / SINEโ„ข Compound and Ifosfamide, Carboplatin, Etoposide (ICE) in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

Study Focus

Selinexor

Interventional

drug

Sponsor & Location

National Cancer Centre, Singapore

Singapore, Singapore

Timeline & Enrollment

Phase 1

Jul 01, 2016

Nov 01, 2020

11 participants

Primary Outcome

Number of participants with treatment related dose limiting toxicity as assessed by NCI CTCAE v4.0

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.

ICD-10 Classifications

Peripheral T-cell lymphoma, not elsewhere classified
Cutaneous T-cell lymphoma, unspecified
Mature T/NK-cell lymphomas
Angioimmunoblastic T-cell lymphoma
Other mature T/NK-cell lymphomas

Data Source

ClinicalTrials.gov

NCT03212937

Non-Device Trial