Phase 1
Completed N=15
Effect of Rifampin on the Pharmacokinetics of Ixabepilone in Patients With Advanced Cancer
Solid Tumors · Neoplasms
Source: ClinicalTrials.gov NCT00207090 ↗
Enrolled (actual)
15
Serious AEs
26.7%
Results posted
Oct 2010
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) — 338.23; 308.37 nanogram (ng)/millilter(mL)
Summary
The purpose of this study is to test how rifampin affects the removal of BMS-247550 (ixabepilone) from the body.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) |
338.23; 308.37 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC [INF]) |
3028.70; 1713.07 | — |
| PRIMARY Time Taken for Plasma Concentration to Reduce by 50 Percent or Apparent Terminal Plasma Elimination Half-life (T Half) |
50.85; 36.45 | — |
| PRIMARY Mean Residence Time Adjusted for Infusion Time (MRT [INF]) |
50.93; 29.86 | — |
| PRIMARY Total Body Clearance (CLT) |
28.36; 49.99 | — |
| PRIMARY Volume of Distribution at Steady-state (Vss) |
1323.26; 1447.54 | — |
| PRIMARY Time to Reach Maximum Observed Concentration (T Max) |
1.57; 1.50 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-T]) |
3015.45; 1478.31 | — |
| PRIMARY Urine 6B-Hydroxycortisol to Cortisol Ratio on Day -1 |
10.04; 9.29 | — |
| PRIMARY Urine 6B-Hydroxycortisol to Cortisol Ratio on Day 22 |
110.88; 62.42 | — |
| SECONDARY Number of Participants Who Died and Who Experienced Other Serious AEs (SAEs), Grade 3-4 AEs, Drug-related AEs and AEs Leading to Study Drug Discontinuation |
0; 4; 15; 10; 3 | — |
| SECONDARY Number of Participants With Grade 3-4 Hematology Abnormalities |
5; 6; 5; 1; 6; 0 | — |
| SECONDARY Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Bilirubin, Albumin and Phosphorous |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Calcium, Magnesium, Potassium, Sodium, Glucose and Uric Acid. |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Meaningful Vital Signs Measures |
— | — |
| SECONDARY Number of Participants With Abnormal Physical Examination Findings |
3; 0 | — |
| SECONDARY QT Interval Corrected for Heart Rate (QTcF) |
3.44; 5.64; 0.57; 7.82; 6.54; -10.70 | — |
| SECONDARY Number of Participants With Identified ECG Abnormalities |
13; 1; 0; 13 | — |
Eligibility Criteria
Inclusion Criteria
- Up to three prior chemotherapy regimens
- Measurable or non-measurable disease
- Available for treatment and follow-up
Exclusion Criteria
- Neuropathy
- Uncontrolled cardiovascular disease
- Refusal to participate in genetic analysis
Data sourced from ClinicalTrials.gov (NCT00207090). 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.