A Phase I/II Study of BMS-247550 [ixabepilone] and Pegylated Liposomal Doxorubicin (Doxil) in Patients With Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer Who Have Been Previously Treated With a Platinum and a Taxane and Phase I Study of Patients With Metastatic Breast Cancer
Phase of Trial: Phase I/II
Latest Information Update: 14 Mar 2016
At a glance
- Drugs Doxorubicin liposomal (Primary) ; Ixabepilone (Primary)
- Indications Advanced breast cancer; Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
- Focus Adverse reactions
- 31 Aug 2018 Biomarkers information updated
- 09 Mar 2016 A protocol amendment was made during phase I trial from a treatment regimen of Schedule A (ixabepilone every 3-4 weeks) to Schedule B (ixabepilone every week). The maximum tolerated dose was determined to be the preceding dose of any dose that resulted in 2 DLT events. Schedule B was carried forward to the phase II trial. The Maximum Tolerated Dose for Schedule B is reported.
- 15 May 2013 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.