Dose Escalation Study of NKP-1339 to Treat Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT01415297|
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : May 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: NKP-1339||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||October 2009|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||January 2016|
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.
Other Name: IT-139
- Number of participants with related adverse events [ Time Frame: 8 weeks ]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 ]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 ]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 ]Transferrin, transferrin receptor and GRP-78 in plasma.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|