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Selinexor in Combination With Imatinib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors.

2019-10-29 14:36:39 | BioPortfolio

Summary

This is a single-arm, open label phase I/II clinical trial studying the combination of oral imatinib 400 mg, once daily, and oral selinexor given once weekly. The study will consist of an initial escalation phase evaluating increasing doses of selinexor in combination with fixed doses of imatinib administered in repeated 28-day cycles in advanced/metastatic, TKI-refractory GIST patients, followed by an expansion phase testing for safety and preliminary evidence of antitumor activity.

Description

Clinical Study Objectives:

Primary clinical study objective

1.- To determine the maximum tolerated dose (MTD) and recommended phase II doses (RP2D) of selinexor in combination with imatinib among unresectable and/or metastatic GIST patients with prior failure to at least imatinib for advanced/metastatic disease. Secondary clinical study objectives

1. - To evaluate the clinical benefit rate (CBR: CR+PR+ SD ≥ 16 wks).

2. - To evaluate progression free survival (PFS).

3. - To evaluate overall survival (OS).

4. - To evaluate the objective response rate (ORR).

5. - To evaluate the safety profile according to CTCAE 4.03.

6. - To compare PFS on selinexor and imatinib with PFS on last prior anti-cancer therapy.

Translational Study Objective:1.- To explore the relationship between GIST genotype and CBR with selinexor and imatinib.

Pharmacokinetics Study Objective: 1.- To measure the plasma concentration of imatinib and selinexor at limited timepoints specificed in schedule of assessment.

Study Design

Conditions

Maximum Tolerated Dose

Intervention

Selinexor, Imatinib

Location

Hospital Virgen del Rocio
Sevilla
Andalucia
Spain
41013

Status

Recruiting

Source

Grupo Espanol de Investigacion en Sarcomas

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-29T14:36:39-0400

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