Dose Escalation Study of NKP-1339 to Treat Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

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.

Key facts

Study ID

NCT01415297

Run by

Niiki Pharma Inc.

People needed

46

Starts

2009-10-01

Expected to finish

2016-01-01

Last updated by the study team

2017-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• TGEN Clinical Research Services at Scottsdale Healthcare — Scottsdale, Arizona, United States
• The Sarah Cannon Research Institute — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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