Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced or Metastatic Solid Tumor Cancer
The purpose of this research study is to find out more information such as: the highest dose of KPT-330 that can be given safely, the side effects it may cause, to examine how the body affects the study drug concentrations in the blood (pharmacokinetics or PK), to examine the effects of this study drug on the body (pharmacodynamics or PDn) and to gain some information on its effectiveness in treating cancer.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of the Safety, Pharmacokinetics and Pharmacodynamics of Escalating Doses of the Selective Inhibitor of Nuclear Export/SINE Compound KPT-330 in Patients With Advanced or Metastatic Solid Tumor Malignancies|
- Number of participants with Adverse Events [ Time Frame: 2 and 12 months ] [ Designated as safety issue: Yes ]Severity of Adverse Events
- Area under the plasma concentration versus time curve (AUC) of KPT-330 [ Time Frame: 2 and 12 months ] [ Designated as safety issue: No ]Changes in AUC over time
|Study Start Date:||June 2012|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
|Experimental: Solid Tumors||
Schedule 1: Starting dose of KPT-330 will be 3mg/m2 (PO) 3X/week every other day, (QODx3/wk) for weeks 1 and 3. For weeks 2 and 4, drug will be dosed on days 1 and 3.
Schedule 2: Starting dose of KPT-330 will be > 12mg/m2 (PO) 3X/week every other day for week -1; QODx3/wk for weeks 1 and 3. For weeks 2 and 4 drug will be dosed on days 1 and 3. For cycles 2 and beyond, drug admin will be 3X/week every other day, (QODx3/wk) for weeks 1 and 3. For weeks 2 and 4, drug will be dosed on days 1 and 3.
Schedule 3: Starting dose will be ≥ 30mg/m2, 2x/week on days 1 and 3 of each week.
Schedule 4: Starting dose will be ≥ 20mg/m2, 2x/week on consecutive days 1 and 2 of each week.
Schedule 5: Starting dose will be ≥ 30mg/m2, 2x/week on days 1 and 4 of each week.
Schedule 6: Starting dose will be ≥ 20mg/m2, twice a week on days 1 and 4 of each week.
Schedule 7: Once weekly schedule for doses ≥ 50mg/m2
Schedule 8: Twice weekly schedule for ≥45 mg/m2 doses
Other Name: Selinexor
Please refer to this study by its ClinicalTrials.gov identifier: NCT01607905
|United States, Florida|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, Michigan|
|Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Ohio|
|Gabrail Cancer Center|
|Canton, Ohio, United States, 44718|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5T 2M9|
|Copenhagen, Denmark, 2100|