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NCT00104468
An Open-Label, Single-Arm, Multi-Center, Phase I Study of Troxatyl™ (Troxacitabine) Administered by Continuous Infusion in Subjects With Refractory Acute Myelogenous Leukemia
Phase 1/Phase 2 trial testing Troxatyl™ (Cytotoxic Chemotherapeutic) in Acute Myelogenous Leukemia in 50 participants. Terminated before completion.
1 June 2007
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 April 2003 |
| Primary completion | 1 June 2007 |
| Estimated completion | 1 June 2007 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Troxatyl™ (Cytotoxic Chemotherapeutic) — full drug profile →
Conditions studied
- Acute Myelogenous Leukemia — all drugs for Acute Myelogenous Leukemia →
Sponsor
SGX Pharmaceuticals, Inc. — full company profile →
Who can join
18 and older, any sex, with Acute Myelogenous Leukemia. 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 with regards to dose limiting toxicities.
Sponsor's own description
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™.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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
Verify or expand the search:
- PubMed search for NCT00104468
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00104468 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by SGX Pharmaceuticals, Inc.
- Last refreshed: 14 January 2008
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00104468.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing