NCT01415297

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

Completed Phase 1 Last updated 18 May 2017

What this trial tests

Phase 1 trial testing NKP-1339 in Solid Tumors in 46 participants. Completed in 1 January 2016.

Timeline

1 October 2009

Primary endpoint
1 May 2012

1 January 2016

Quick facts

Lead sponsor	Niiki Pharma Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	46
Start date	1 October 2009
Primary completion	1 May 2012
Estimated completion	1 January 2016
Sites	2 locations across United States

Drugs / interventions tested

• NKP-1339 — full drug profile →

Conditions studied

• Solid Tumors — all drugs for Solid Tumors →

Sponsor

Niiki Pharma Inc. — full company profile →

Who can join

18 and older, any sex, with Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Metallodrugs are unique: opportunities and challenges of discovery and development.
   Anthony EJ, Bolitho EM, Bridgewater HE, Carter OWL, et al · · 2020 · cited 372× · PMID 34123239 · DOI 10.1039/d0sc04082g
2. Hypoxia-targeted drug delivery.
   Sharma A, Arambula JF, Koo S, Kumar R, et al · · 2019 · cited 336× · PMID 30575832 · DOI 10.1039/c8cs00304a
3. 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.
   Burris HA, Bakewell S, Bendell JC, Infante J, et al · · 2016 · cited 115× · PMID 28848672 · DOI 10.1136/esmoopen-2016-000154
4. The Unfolded Protein Response in Breast Cancer.
   McGrath EP, Logue SE, Mnich K, Deegan S, et al · · 2018 · cited 70× · PMID 30248920 · DOI 10.3390/cancers10100344
5. Ruthenium Complexes: An Alternative to Platinum Drugs in Colorectal Cancer Treatment.
   Mahmud KM, Niloy MS, Shakil MS, Islam MA. · · 2021 · cited 37× · PMID 34452256 · DOI 10.3390/pharmaceutics13081295
6. Bioactivity and Development of Small Non-Platinum Metal-Based Chemotherapeutics.
   Ferraro MG, Piccolo M, Misso G, Santamaria R, et al · · 2022 · cited 35× · PMID 35631543 · DOI 10.3390/pharmaceutics14050954
7. Identifying Novel Actionable Targets in Colon Cancer.
   Cerrito MG, Grassilli E. · · 2021 · cited 23× · PMID 34065438 · DOI 10.3390/biomedicines9050579
8. Controversial Role of Transferrin in the Transport of Ruthenium Anticancer Drugs.
   Levina A, Chetcuti ARM, Lay PA. · · 2022 · cited 14× · PMID 36139158 · DOI 10.3390/biom12091319