NCT00207090|CompletedPhase 1Results
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Sponsor study identifier
interventional
19
1 country
1
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2008
Actual (reported)Study Completion
November 2008
Actual (reported)The purpose of this study is to test how rifampin affects the removal of BMS-247550 (ixabepilone) from the body.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
September 12, 2005
Actual (reported)September 21, 2005
Actual (reported)November 2008
Actual (reported)November 2008
Actual (reported)October 1, 2010
Actual (reported)Maximum Plasma Concentration (Cmax)
Cmax was obtained directly from the concentration-time data.
Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC [INF])
AUC (INF) was obtained directly from the concentration-time data.
Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.
Time Taken for Plasma Concentration to Reduce by 50 Percent or Apparent Terminal Plasma Elimination Half-life (T Half)
T half was obtained directly from the concentration-time data.
Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.
Mean Residence Time Adjusted for Infusion Time (MRT [INF])
(MRT \[INF\]) was obtained directly from the concentration-time data.
Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.
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
From Day 1 to 30 days after the last dose of study drug.
Number of Participants With Grade 3-4 Hematology Abnormalities
Screening, Day 1, Day 8, Day 15, Day 22 and Day 29-36.
Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Bilirubin, Albumin and Phosphorous
Screening, Days 1 and 22.
Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Calcium, Magnesium, Potassium, Sodium, Glucose and Uric Acid.
Screening, Days 2 and 22.
Number of Participants With Clinically Meaningful Vital Signs Measures
From screening to the off treatment visit.
ixabepilone solution, intravenous, 40 mg/m2, once every 3 weeks until disease progression
rifampin tablets, oral, 600 mg once daily, only on Days 15 to 21 of Cycle 1 and Days 1 to 7 of Cycle 2
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Bristol-Myers Squibb
Bristol-Myers Squibb
19 participants (actual enrollment reported by the registry).
First Submitted
September 12, 2005
First Posted
September 21, 2005
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Clinical Study of Ixabepilone Administered as a 24 Hour Infusion in Patients With Solid Malignancies.
Total Body Clearance (CLT)
CLT was obtained directly from the concentration-time data.
Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.
Volume of Distribution at Steady-state (Vss)
Vss was obtained directly from the concentration-time data.
Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.
Time to Reach Maximum Observed Concentration (T Max)
T max was obtained directly from the concentration-time data.
Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.
Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-T])
AUC (0-T) was obtained directly from the concentration-time data.
Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.
Urine 6B-Hydroxycortisol to Cortisol Ratio on Day -1
The urine 6B-hydroxycortisol to cortisol ratio is a measure of hepatic CYP3A4/3A5 activity, which is a potential marker of the rate of clearance of ixabepilone. The urine 6B-hydroxycortisol to cortisol ratios were calculated on Day -1.
Day -1 (0-8 hours and 8-24 hours), 24 hours before starting of ixabepilone administration.
Urine 6B-Hydroxycortisol to Cortisol Ratio on Day 22
The urine 6B-hydroxycortisol to cortisol ratio is a measure of hepatic CYP3A4/3A5 activity, which is a potential marker of the rate of clearance of ixabepilone. The urine 6B-hydroxycortisol to cortisol ratios were calculated on Day -1.
Day 22 (0-8 hours and 8-24 hours) during ixabepilone and rifampin co-administration.
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Primary Completion
November 2008
Actual (reported)Study Completion
November 2008
Actual (reported)Last Updated
November 2, 2020
Results First Posted
October 1, 2010
Record last verified: 2020-10
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Source: ClinicalTrials.gov.
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