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Phase I Study of KPT330 in Asian Patients

NCT02078349 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-09-10

No results posted yet for this study

Summary

This is an open-label, dose-escalation (Phase 1a) and expansion (Phase 1b) study to evaluate the safety and tolerability of KPT-330 and determine the recommended phase 2 dose (RP2D) in patients with solid tumor malignancies. The study drug KPT-330 or Selinexor works by blocking high levels of exporter proteins in cancer cells so that the tumor suppressor proteins (TSP, proteins that help to protect cells from becoming cancerous) and growth regulatory proteins (GRP, proteins that help control the growth of cells) will remain in the nucleus in its "activated" form. The idea for using this drug is that the blockage of this export of proteins from the nucleus should result in stopping the growth of tumor cells. Based on its mechanism of action, KPT-330 is a new class of drug called Selective Inhibitor of Nuclear Export (SINE).

The purposes of this research study are to find out more information about the drug such as: the highest dose of KPT-330 that can be given safely, the side effects it may cause, to examine how the body affects the study drug concentrations in the blood (called pharmacokinetics or PK), to examine the effects of this study drug on the body (called pharmacodynamics or PD) and to gain some information on its usefulness in treating cancer.

Benefits of the study include the chance of disease control for patients with treatment refractory cancer for which no other standard treatments are available. Common side effects (35-73%) in humans have mostly been mild and reversible. These include nausea, loss of appetite, fatigue, vomiting and weight loss.

Conditions

Interventions

DRUG

KPT-330

Each dose will consist of KPT-330 (Selinexor) for oral administration on an mg/m2 basis, and should be based on the patient's actual calculated body surface area (BSA) at baseline. Patients with a BSA \>2.5 m(2) will receive a dose based upon a 2.5 m(2) BSA.

Sponsors & Collaborators

  • Karyopharm Therapeutics Inc

    collaborator INDUSTRY

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Boon Cher Goh, MBBS · National University Hospital, Singapore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2020-03-20
Completion
2020-03-20

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

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 NCT02078349 on ClinicalTrials.gov