Abstract | PURPOSE: The epothilones are a novel class of microtubule- stabilizing agents. UTD1 is an epothilone analog generated by genetic manipulation of the polyketide biosynthetic gene cluster. This phase I study was designed to evaluate the safety and pharmacokinetic(PK) profiles of UTD1 in patients with advanced solid tumors. PATIENTS AND METHODS: This was an open-label, single-arm, one site, phase I, dose-escalation study. Patients were treated with escalating doses of UTD1 as a 3-h intravenous infusion every 3 weeks. RESULTS: CONCLUSIONS: The recommended phase II dose of UTD1 is 170 mg/m(2) as a 3-h infusion every 3 weeks. Ataxia was the DLT. UTD1 showed advantages over paclitaxel and Ixapebilone in relation to safety profile, especially myelosuppression. The acceptable tolerability warrants further phase II study.
|
Authors | Pin Zhang, Mingyuan Sun, Rongguo Qiu, Li Tang, Guifang Dou, Binghe Xu |
Journal | Cancer chemotherapy and pharmacology
(Cancer Chemother Pharmacol)
Vol. 68
Issue 4
Pg. 971-8
(Oct 2011)
ISSN: 1432-0843 [Electronic] Germany |
PMID | 21305287
(Publication Type: Clinical Trial, Phase I, Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Antineoplastic Agents
- Epothilones
- ixabepilone
- Paclitaxel
|
Topics |
- Adult
- Antineoplastic Agents
(administration & dosage, adverse effects, pharmacokinetics)
- Ataxia
(chemically induced)
- Dose-Response Relationship, Drug
- Epothilones
(administration & dosage, adverse effects, pharmacokinetics, therapeutic use)
- Female
- Genetic Engineering
- Humans
- Infusions, Intravenous
- Male
- Maximum Tolerated Dose
- Middle Aged
- Neoplasms
(drug therapy, pathology)
- Paclitaxel
(adverse effects, therapeutic use)
- Treatment Outcome
|