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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Niiki Pharma Inc.

ClinicalTrials.gov Identifier:

NCT01415297

First received: August 3, 2011

Last updated: December 31, 2012

Last verified: December 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Solid Tumors	Drug: NKP-1339	Phase 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Niiki Pharma Inc.:

Primary Outcome Measures:

Number of participants with related adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
The incidence and severity of related adverse events and laboratory abnormalities will be used to assess the safety and tolerability of NKP-1339.

Secondary Outcome Measures:

Composite of pharmacokinetics [ Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 10 and 24 hours ] [ Designated as safety issue: No ]
Plasma and urine samples will be analyzed to determine Cmax, Tmax, AUC, terminal elimination rate, elimination half-life, clearance,and volume of distribution.
To report any responses to NKP-1339 in subjects with advanced tumors [ Time Frame: >8 weeks ] [ Designated as safety issue: No ]
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.
To explore pharmacodynamic endpoints which may be of use in the further development of NKP-1339 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Transferrin, transferrin receptor and GRP-78 in plasma.

Estimated Enrollment:	50
Study Start Date:	September 2009
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: NKP-1339 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.	Drug: 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.

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415297

Locations

United States, Arizona
TGEN Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
United States, Tennessee
The Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203

Sponsors and Collaborators

Niiki Pharma Inc.

Investigators

Principal Investigator:	Daniel D. Von Hoff, MD	TGEN Clinical Research Services at Scottsdale Healthcare
Principal Investigator:	Howard A. Burris, III, MD	The Sarah Cannon Research Institute

More Information

No publications provided

Responsible Party:	Niiki Pharma Inc.
ClinicalTrials.gov Identifier:	NCT01415297 History of Changes
Other Study ID Numbers:	NKP-1339-09-002
Study First Received:	August 3, 2011
Last Updated:	December 31, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Niiki Pharma Inc.:

Phase 1
advanced solid tumors

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013

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