NCT00104286

An Open-Label, Single-Arm, Phase I Study of Troxatyl™ (Troxacitabine) Administered by Continuous Infusion in Subjects With an Advanced Solid Malignancy

Terminated Phase 1/Phase 2 Last updated 1 November 2006

What this trial tests

Phase 1/Phase 2 trial testing Troxatyl™ (Cytotoxic Chemotherapeutic) in Neoplasms in 50 participants. Terminated before completion.

Timeline

1 January 2003

1 November 2005

Quick facts

Lead sponsor	SGX Pharmaceuticals, Inc.
Phase	Phase 1/Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 January 2003
Estimated completion	1 November 2005
Sites	1 location across United States

Drugs / interventions tested

• Troxatyl™ (Cytotoxic Chemotherapeutic) — full drug profile →

Conditions studied

• Neoplasms — all drugs for Neoplasms →

Sponsor

SGX Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with Neoplasms. 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.

• To determine the recommended infusion schedule for the investigational new drug administered as a continuous infusion, and to define the safety tolerance and dose limiting toxicities.

Sponsor's own description

This is a phase I, single-arm, open-label, single-center study to establish the recommended infusion schedule for Troxatyl™ administered as a continuous infusion for 2-5 days to subjects with solid tumors.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Metabolism, Biochemical Actions, and Chemical Synthesis of Anticancer Nucleosides, Nucleotides, and Base Analogs.
   Shelton J, Lu X, Hollenbaugh JA, Cho JH, et al · · 2016 · cited 219× · PMID 27960273 · DOI 10.1021/acs.chemrev.6b00209