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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01415297
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : May 19, 2017
Information provided by (Responsible Party):
Intezyne Technologies, Inc. ( Niiki Pharma Inc. )

Brief 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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: NKP-1339 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : October 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : January 2016

Arm Intervention/treatment
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.
Other Name: IT-139

Primary Outcome Measures :
  1. Number of participants with related adverse events [ Time Frame: 8 weeks ]
    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 :
  1. Composite of pharmacokinetics [ Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 10 and 24 hours ]
    Plasma and urine samples will be analyzed to determine Cmax, Tmax, AUC, terminal elimination rate, elimination half-life, clearance,and volume of distribution.

  2. To report any responses to NKP-1339 in subjects with advanced tumors [ Time Frame: >8 weeks ]
    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.

  3. To explore pharmacodynamic endpoints which may be of use in the further development of NKP-1339 [ Time Frame: 8 weeks ]
    Transferrin, transferrin receptor and GRP-78 in plasma.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01415297

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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.
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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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Niiki Pharma Inc. Identifier: NCT01415297    
Other Study ID Numbers: NKP-1339-09-002
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Intezyne Technologies, Inc. ( Niiki Pharma Inc. ):
Phase 1
advanced solid tumors
Additional relevant MeSH terms:
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