drugset / Trial / NCT00753740
Efficacy Study of Maintenance IT-101 Therapy for Ovarian Cancer Patients.
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will assess the effect of IT-101 on delaying cancer progression in patients with platinum sensitive ovarian cancer.
Timeline
- Start
- 2008-09
- Primary completion
- 2009-10
- Completion
- 2010-05
Publications
- Background Schluep T, Hwang J, Cheng J, Heidel JD, Bartlett DW, Hollister B, Davis ME. Preclinical efficacy of the camptothecin-polymer conjugate IT-101 in multiple cancer models. Clin Cancer Res. 2006 Mar 1;12(5):1606-14. doi: 10.1158/1078-0432.CCR-05-1566.
- Background Schluep T, Cheng J, Khin KT, Davis ME. Pharmacokinetics and biodistribution of the camptothecin-polymer conjugate IT-101 in rats and tumor-bearing mice. Cancer Chemother Pharmacol. 2006 May;57(5):654-62. doi: 10.1007/s00280-005-0091-7. Epub 2005 Aug 26.
- Background Cheng J, Khin KT, Davis ME. Antitumor activity of beta-cyclodextrin polymer-camptothecin conjugates. Mol Pharm. 2004 May-Jun;1(3):183-93. doi: 10.1021/mp049966y.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DAVAMOTECAN PEGADEXAMER | Other / unclassified | 12 mg/m2 | Other |
| Subject | DAVAMOTECAN PEGADEXAMER | Other / unclassified | 15 mg/m2 | Other |