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TerminatedNCT00104468Updated Jan 17, 2008

Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Refractory Acute Myelogenous Leukemia (AML)

A Phase 1/2 interventional study of Troxatyl™ (Cytotoxic Chemotherapeutic) in Acute Myelogenous Leukemia, sponsored by SGX Pharmaceuticals, Inc.. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-01-17.

Sponsored by SGX Pharmaceuticals, Inc. · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Trial stopped June 2007
Phase
Phase 1/2
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a phase I, single-arm, open-label, multi-center study of rising doses of Troxatyl™ whose purpose is to determine the safety, tolerance, and pharmacokinetics, and to establish the recommended infusion schedule of Troxatyl™.

02

Conditions studied

  • Acute Myelogenous Leukemia

Keywords

  • Single-arm, open-label, multi-center, dose escalation, continuous infusion, multi-dose, acute myeloid leukemia
  • Acute myelogenous leukemia (AML) that has been refractory to prior therapy and/or is unlikely to benefit from known therapies
03

In context

Leukemia

5,442 studies on the registry are indexed under Leukemia; 637 are open to participants now.

This study's enrollment of 50 is above the median of 38 across 4,248 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

SGX Pharmaceuticals, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Confirmed diagnosis of acute myelogenous leukemia (AML) refractory to prior therapy and/or unlikely to benefit from known therapies.
  • Subjects must have adequate organ and immune function as indicated by the following laboratory values: *Creatinine clearance ≥5 L/hr (83mL/min), *Total Bilirubin ≤2.0 mg/dL (≤34.2 µmol/L), *AST(SGOT) and ALT(SGPT) ≤3 x ULN

Exclusion criteria

Exclusion Criteria:

  • Clinical evidence of active central nervous system (CNS) leukemic involvement
  • Active and uncontrolled infection
  • Uncontrolled medical problems unrelated to the malignancy that impair their ability to give informed consent or unacceptably reduce the safety of the proposed treatment
  • Neurologic or psychiatric disorders that would interfere with informed consent or study follow-up
  • Known or suspected intolerance or hypersensitivity to the investigational new drug or closely related compounds like lamivudine, and/or a recent history of alcohol or other substance abuse.
  • Also not eligible are subjects who have used another investigational agent or participated in a clinical trial within the last 14 days prior to enrollment.
  • Females with a positive pregnancy test at screening or subjects that have previously been enrolled into this study and subsequently withdrew.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants

Interventions

  • DrugTroxatyl™ (Cytotoxic Chemotherapeutic)
06

What researchers measure

Primary outcomes

  1. To determine the recommended infusion schedule for the investigational new drug administered as a continuous infusion with regards to dose limiting toxicities.

Secondary outcomes

  1. Pharmacokinetic/pharmacodynamic profile, preliminary evidence of the anti-tumor activity.

07

Study locations

2 sites
  • Cornell Medical College, New York Presbyterian
    New York, New York 10021, United States
  • MD Anderson
    Houston, Texas 77030, United States
08

References and documents

Publications

  • Giles FJ. Troxacitabine-based therapy of refractory leukemia. Expert Rev Anticancer Ther. 2002 Jun;2(3):261-6. doi: 10.1586/14737140.2.3.261. PubMed 12113049 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00104468
Lead sponsor
SGX Pharmaceuticals, Inc.
First posted
Mar 1, 2005
Start date
Apr 2003
Primary completion
Jun 2007
Completion
Jun 2007
Last update
Jan 17, 2008
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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