NCT01415297

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

2.6 years

First QC Date

August 3, 2011

Last Update Submit

May 18, 2017

Conditions

Solid Tumors

Keywords

Phase 1advanced solid tumors

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Composite of pharmacokinetics

    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

    >8 weeks

  • To explore pharmacodynamic endpoints which may be of use in the further development of NKP-1339

    8 weeks

Study Arms (1)

NKP-1339

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.

Drug: NKP-1339

Interventions

NKP-1339DRUG

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.

Also known as: IT-139
NKP-1339

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

TGEN Clinical Research Services at Scottsdale Healthcare

Scottsdale, Arizona, 85258, United States

Location

The Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

  • Burris HA, Bakewell S, Bendell JC, Infante J, Jones SF, Spigel DR, Weiss GJ, Ramanathan RK, Ogden A, Von Hoff D. Safety and activity of IT-139, a ruthenium-based compound, in patients with advanced solid tumours: a first-in-human, open-label, dose-escalation phase I study with expansion cohort. ESMO Open. 2017 Feb 23;1(6):e000154. doi: 10.1136/esmoopen-2016-000154. eCollection 2016.

    PMID: 28848672DERIVED

MeSH Terms

Interventions

NKP-1339

Study Officials

  • Daniel D. Von Hoff, MD

    TGEN Clinical Research Services at Scottsdale Healthcare

    PRINCIPAL INVESTIGATOR

  • Howard A. Burris, III, MD

    The Sarah Cannon Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2011

First Posted

August 11, 2011

Study Start

October 1, 2009

Primary Completion

May 1, 2012

Study Completion

January 1, 2016

Last Updated

May 19, 2017

Record last verified: 2017-05

Locations

US(2)