Dose Escalation Study of NKP-1339 to Treat Advanced Solid Tumors
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Dose Escalation Study of NKP-1339 Administered on Days 1, 8 and 15 of Each 28-Day Cycle in Patients With Advanced Solid Tumors Refractory to Treatment|
- Number of participants with related adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]The incidence and severity of related adverse events and laboratory abnormalities will be used to assess the safety and tolerability of NKP-1339.
- Composite of pharmacokinetics [ Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 10 and 24 hours ] [ Designated as safety issue: No ]Plasma and urine samples will be analyzed to determine Cmax, Tmax, AUC, terminal elimination rate, elimination half-life, clearance,and volume of distribution.
- To report any responses to NKP-1339 in subjects with advanced tumors [ Time Frame: >8 weeks ] [ Designated as safety issue: No ]Tumor assessments every 2 cycles if patients continue treatment beyond 2 Cycles. Treatment is allowed beyond 2 cycles in patients who achieved at least stable disease, at the discretion of investigator and consent of the patient.
- To explore pharmacodynamic endpoints which may be of use in the further development of NKP-1339 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Transferrin, transferrin receptor and GRP-78 in plasma.
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||May 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
NKP-1339 will be administered in single patient cohorts until ≥ Grade 2 toxicity encountered, at which time cohorts converted to a standard 3 + 3 dose escalation scheme.
When MTD is reached, an expanded cohort of up to 25 patients will be enrolled at the MTD.
NKP-1339 is administered as a 30-90 minute IV infusion (based on volume to be infused) on days 1, 8, and 15 of a 28 day cycle.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415297
|United States, Arizona|
|TGEN Clinical Research Services at Scottsdale Healthcare|
|Scottsdale, Arizona, United States, 85258|
|United States, Tennessee|
|The Sarah Cannon Research Institute|
|Nashville, Tennessee, United States, 37203|
|Principal Investigator:||Daniel D. Von Hoff, MD||TGEN Clinical Research Services at Scottsdale Healthcare|
|Principal Investigator:||Howard A. Burris, III, MD||The Sarah Cannon Research Institute|