Phase 1
Completed N=35
Clinical Study of Ixabepilone Administered as a 24 Hour Infusion in Patients With Solid Malignancies.
Source: ClinicalTrials.gov NCT00162136 ↗Enrolled (actual)
35
Serious AEs
45.7%
Results posted
Jan 2010
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicities at Dose Level — 0; 0; 0; 0 participants
Summary
The purpose of this study is to determine the dose limiting toxicities, minimum tolerated dose and recommended dose for Phase II studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities at Dose Level |
0; 0; 0; 0; 1; 2 | — |
| SECONDARY Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation |
12; 21; 33; 16; 0; 16 | — |
| SECONDARY Hematology Results - Worst On-Study Grade |
5; 5; 8; 10; 7; 8 | — |
| SECONDARY Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level |
0; 20.79; 24.31; 33.15; 32.04; 35.25 | — |
| SECONDARY Best Tumor Response, According to Response Evaluation Criteria in Solid Tumors (RECIST) |
0; 0; 14; 15; 6 | — |
Eligibility Criteria
Inclusion Criteria
- confirmed diagnosis of a primary solid tumor
- measurable or non-measurable disease
- progressive disease
- men and women greater or equal to 18 years of age.
Exclusion Criteria
- women of child bearing potential who are not using birth control
- women who are pregnant or breast feeding
- women with a positive pregnancy test on enrollment
- patients with brain metastasis
- prior treatment with Ixabepilone
- known history of human immunodeficiency virus (HIV)
Data sourced from ClinicalTrials.gov (NCT00162136). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.