TRIAL DETAIL

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

Drug:	Imatinib + Selinexor
Trial Name:	Selinexor in Combination With Imatinib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors. (SeliGIST)
NCT#:	NCT04138381
Conditions:	Gastrointestinal Stromal Tumor
Status:	Active, not recruiting
Phase:	1/2	Start Date 08/16/2019	Age of Trial (yrs) 5.3
Treatment Phase:	Gleevec-resistant
Drug Category:	KIT + Nuclear export inhibitor
Strategy:	Inhibit KIT and arrest cell cycle
Trial Type:	Specifically GIST and only GIST
Other Protocol IDs:	SeliGIST GEIS 41 2017-004761-28 ( EudraCT Number )
Sponsor:	Grupo Espanol de Investigacion en Sarcomas
Patient Contact:	Beatriz Suarez, PhD 658232638 beatriz.suarez.crc@grupogeis.org Melissa Fernandez, PM 658232638 melissacrc@grupogeis.org
Contact email:
Contact Phone:
Randomized:
IV or Oral:	Oral
Trial Notes:	Brief 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.