Spots Global Cancer Trial Database for Selinexor in Combination With Irinotecan in Adenocarcinoma of Stomach and Distal Esophagus

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Selinexor in Combination With Irinotecan in Adenocarcinoma of Stomach and Distal Esophagus

Official Title: An Investigator Sponsored Phase 1a/1b Trial of Selinexor in Combination With Irinotecan in Patients With Adenocarcinoma of Stomach and Distal Esophagus

Study ID: NCT02283359

Conditions

Esophageal Cancer

Gastric Cancer

Interventions

Selinexor

Irinotecan

Study Description

Brief Summary: The main purpose of this study is to see whether the combination of selinexor (KPT-330) and irinotecan can help people with esophageal or stomach cancer. Researchers also want to find out if the combination of selinexor (KPT-330) and irinotecan is safe and tolerable.

Detailed Description: This is an open label, single group, non-randomized, phase I study with cohort expansion that utilizes the standard 3+3 design for dose. The dose of selinexor will be escalated in combination with the standard doses of irinotecan. The maximum tolerated dose (MTD) for study is defined as the highest dose level at which 1 or less of 6 patients experience a dose limiting toxicity DLT. Once the MTD is reached and/or the recommended dose for expansion is determined, an additional cohort of 15 patients with advanced gastric or esophageal cancer will be accrued to better define the safety and tolerability of the combination regimen.