Dose Escalation Study of NKP-1339 to Treat Advanced Solid Tumors
This trial is active, not recruiting.
|Sponsor||Niiki Pharma Inc.|
|Start date||September 2009|
|End date||December 2012|
|Trial size||50 participants|
|Trial identifier||NCT01415297, NKP-1339-09-002|
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 solid tumors. The responses to treatment in this population will be evaluated. In addition, the PD and PK properties of the compound will be explored.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Number of participants with related adverse events
time frame: 8 weeks
Composite of pharmacokinetics
time frame: 0, 0.25, 0.5, 1, 2, 4, 6, 10 and 24 hours
To report any responses to NKP-1339 in subjects with advanced tumors
time frame: >8 weeks
To explore pharmacodynamic endpoints which may be of use in the further development of NKP-1339
time frame: 8 weeks
Male or female participants at least 18 years old.
- 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
- 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
|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|
|Principal investigator||Daniel D. Von Hoff, MD|
|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 cells. In nonclinical anti-tumor studies, NKP-1339 showed activity against many tumor types, including those resistant to platinum and other standard anti-cancer agents. This Phase I trial evaluates the safety, tolerability, maximum tolerated dose, pharmacokinetics, and pharmacodynamics of NKP-1339.|
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