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

PHASE1CompletedINTERVENTIONAL
Enrollment

192

Participants

Timeline

Start Date

June 18, 2012

Primary Completion Date

March 15, 2016

Study Completion Date

March 15, 2016

Conditions
Solid Tumor
Interventions
DRUG

Selinexor

Participants in this study will receive selinexor orally at dose levels specified for their respective dose cohorts. Dosing will begin at 3 mg/m\^2 twice a week and will escalate until the MTD or RP2D is determined. Cycles will be repeated in 4-week (28 days for schedule 1 to 7) and 3-week (21 days for schedule 8) intervals until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment will be permitted.

DRUG

Acetaminophen

Oral 500 mg (in Cycle 1, Week 1) to 1000 mg (in Cycle 1, Week 2 and onwards) of acetaminophen will be administered 1 hour prior to each selinexor dose up to 8 doses per cycle (28 days per cycle)

Trial Locations (6)

2100

Rigshospitalet, Copenhagen

10065

Memorial Sloan-Kettering Cancer Center, New York

33612

Moffitt Cancer Center, Tampa

44718

Gabrail Cancer Center, Canton

48201

Karmanos Cancer Institute, Detroit

M5T 2M9

Princess Margaret Hospital, Toronto

Sponsors
All Listed Sponsors
lead

Karyopharm Therapeutics Inc

INDUSTRY