Safety Study of KPT-330 (Selinexor) in Patients With Advanced or Metastatic Solid Tumor Cancer

Phase 1 Completed 192 enrolled Karyopharm Therapeutics Inc

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Phase 1 study to evaluate the safety and tolerability of selinexor and determine the Recommended Phase 2 Dose (RP2D) of selinexor for advanced or metastatic solid tumor malignancies.

Timeline

Start: 2012-06-18
Primary completion: 2016-03-15
Completion: 2016-03-15

Publications

Machlus KR, Wu SK, Vijey P, Soussou TS, Liu ZJ, Shacham E, Unger TJ, Kashyap T, Klebanov B, Sola-Visner M, Crochiere M, Italiano JE Jr, Landesman Y. Selinexor-induced thrombocytopenia results from inhibition of thrombopoietin signaling in early megakaryopoiesis. Blood. 2017 Aug 31;130(9):1132-1143. doi: 10.1182/blood-2016-11-752840. Epub 2017 Jun 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Selinexor	Other / unclassified	3 mg/m2	Oral
Subject	Selinexor	Other / unclassified	12 mg/m2	Oral
Subject	Selinexor	Other / unclassified	20 mg/m2	Oral
Subject	Selinexor	Other / unclassified	30 mg/m2	Oral
Subject	Selinexor	Other / unclassified	35 mg/m2	Oral
Subject	Selinexor	Other / unclassified	45 mg/m2	Oral
Subject	Selinexor	Other / unclassified	50 mg/m2	Oral
Background	Acetaminophen	Small molecule	1000 mg	Oral

Safety Study of KPT-330 (Selinexor) in Patients With Advanced or Metastatic Solid Tumor Cancer

Summary

Timeline

Publications

Drugs

Indications