Overview

This trial is active, not recruiting.

Condition solid tumors
Treatment nkp-1339
Phase phase 1
Sponsor Niiki Pharma Inc.
Start date September 2009
End date December 2012
Trial size 50 participants
Trial identifier NCT01415297, NKP-1339-09-002

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 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

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
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.

Primary Outcomes

Measure
Number of participants with related adverse events
time frame: 8 weeks

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Niiki Pharma Inc..