Status:
COMPLETED
Dose Escalation Study of NKP-1339 to Treat Advanced Solid Tumors
Lead Sponsor:
Niiki Pharma Inc.
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety and maximal tolerated dose of NKP-1339, a ruthenium containing compound administered intravenously on a weekly schedule, in patients with advanced ...
Detailed Description
NKP-1339 is a novel GRP78 targeted ruthenium based anti-cancer compound which is intravenously administered. GRP78 is a key regulator of misfolded protein processing, which is unregulated in cancer ce...
Eligibility Criteria
Inclusion
- Patients ≥ 18 years with histologically or cytologically confirmed advanced solid tumors refractory to standard therapies who have signed an IRB approved Informed Consent Form (ICF).
- ECOG PS 0 or 1.
- Adequate hematologic, hepatic and renal function
- Minimum life expectancy ≥ 12 weeks
Exclusion
- No supplemental Iron, i.e., therapeutic or as part of a multivitamin regimen.
- No chemotherapy, immunotherapy, or radiotherapy for \< 4 weeks, BMTs \< 9 months or major surgery \< 3 weeks.
- No symptomatic central nervous system metastases. No primary brain tumors or known brain metastasis unless clinically stable and on stable or reducing dose of steroids.
- No evidence of ischemia, MI within the past 6 months, or other significant abnormality on ECG.
- No clinically significant active infection including HIV, hepatitis B, or hepatitis C.
- No Peripheral neuropathy ≥ Grade 2
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01415297
Start Date
October 1 2009
End Date
January 1 2016
Last Update
May 19 2017
Active Locations (2)
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1
TGEN Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
2
The Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203