Solid Tumors Clinical Trial
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
Verified date | May 2017 |
Source | Intezyne Technologies, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | January 2016 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | The Sarah Cannon Research Institute | Nashville | Tennessee |
United States | TGEN Clinical Research Services at Scottsdale Healthcare | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Niiki Pharma Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with related adverse events | The incidence and severity of related adverse events and laboratory abnormalities will be used to assess the safety and tolerability of NKP-1339. | 8 weeks | |
Secondary | Composite of pharmacokinetics | Plasma and urine samples will be analyzed to determine Cmax, Tmax, AUC, terminal elimination rate, elimination half-life, clearance,and volume of distribution. | 0, 0.25, 0.5, 1, 2, 4, 6, 10 and 24 hours | |
Secondary | To report any responses to NKP-1339 in subjects with advanced tumors | 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. | >8 weeks | |
Secondary | To explore pharmacodynamic endpoints which may be of use in the further development of NKP-1339 | Transferrin, transferrin receptor and GRP-78 in plasma. | 8 weeks |
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