---
title: Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Refractory Acute Myelogenous Leukemia (AML)
nct_id: NCT00104468
overall_status: TERMINATED
phase: PHASE1, PHASE2
sponsor: SGX Pharmaceuticals, Inc.
study_type: INTERVENTIONAL
primary_condition: Acute Myelogenous Leukemia
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00104468.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00104468"
ct_last_update_post_date: 2008-01-17
last_seen_at: "2026-05-12T06:03:46.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Refractory Acute Myelogenous Leukemia (AML)

**Official Title:** An Open-Label, Single-Arm, Multi-Center, Phase I Study of Troxatyl™ (Troxacitabine) Administered by Continuous Infusion in Subjects With Refractory Acute Myelogenous Leukemia

**NCT ID:** [NCT00104468](https://clinicaltrials.gov/study/NCT00104468)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Trial stopped June 2007
- **Phase:** PHASE1, PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** SGX Pharmaceuticals, Inc.
- **Conditions:** Acute Myelogenous Leukemia
- **Start Date:** 2003-04
- **Completion Date:** 2007-06
- **CT.gov Last Update:** 2008-01-17

## Brief 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™.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **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:

* 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.
```

## Interventions

- **Troxatyl™ (Cytotoxic Chemotherapeutic)** (DRUG)

## Primary Outcomes

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

## Secondary Outcomes

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

## Locations (2)

- Cornell Medical College, New York Presbyterian, New York, New York, United States
- MD Anderson, Houston, Texas, United States

## Recent Field Changes (last 30 days)

- `armsInterventions.interventions` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.cornell medical college, new york presbyterian|new york|new york|united states` — added _(2026-05-12)_
- `locations.md anderson|houston|texas|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00104468.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00104468*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*