At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 35 enrolled
Drug / intervention
Ixabepilonedrug
Likely dose
10–45 mg/m² IV infusion once every 21 daysAI-extracted
Key inclusion· 4
- ✓Confirmed diagnosis of a primary solid tumor
- ✓Measurable or non-measurable disease
- ✓Progressive disease
- ✓Age ≥18 years
Key exclusion· 6
- ✕Women of childbearing potential not using birth control
- ✕Pregnant or breast-feeding women
- ✕Positive pregnancy test at enrollment
- ✕Brain metastases
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I Study of Ixabepilone Administered as a 24-Hour Infusion in Patients With Advanced Solid Malignancies
In Brief
A Phase 1 clinical trial evaluating Ixabepilone for Solid Malignancies. Completed, enrolled 35 participants across 3 sites.
Detailed Summary
The purpose of this study is to determine the dose limiting toxicities, minimum tolerated dose and recommended dose for Phase II studies.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Malignancies
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2005
First PostedSep 2005
Primary CompletionJul 2008
TodayJul 2026
First PostedSep 13, 2005
Enrollment StartSep 1, 2005
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.8 years ago
Interventions
Ixabepilonedrug
Intravenous (IV) Infusion; 10, 20, 30, 35, 40 \& 45 mg/m2, once every 21 days (1 cycle), up to 9 cycles