Clinical trial NCT00207090: Effect of Rifampin on the Pharmacokinetics of Ixabepilone in Patients With Advanced Cancer
Official title: Effect of Rifampin on the Pharmacokinetics of Ixabepilone in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Neoplasms
Lead sponsor: R-Pharm
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test how rifampin affects the removal of BMS-247550 (ixabepilone) from the body.


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

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: 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.
measure: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC [INF])
timeFrame: 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.
measure: Time Taken for Plasma Concentration to Reduce by 50 Percent or Apparent Terminal Plasma Elimination Half-life (T Half)
timeFrame: 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.
measure: Mean Residence Time Adjusted for Infusion Time (MRT [INF])
timeFrame: 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.
measure: Total Body Clearance (CLT)
timeFrame: 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.
measure: Volume of Distribution at Steady-state (Vss)
timeFrame: 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.
measure: Time to Reach Maximum Observed Concentration (T Max)
timeFrame: 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.
measure: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-T])
timeFrame: 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.
measure: Urine 6B-Hydroxycortisol to Cortisol Ratio on Day -1
timeFrame: Day -1 (0-8 hours and 8-24 hours), 24 hours before starting of ixabepilone administration.
measure: Urine 6B-Hydroxycortisol to Cortisol Ratio on Day 22
timeFrame: Day 22 (0-8 hours and 8-24 hours) during ixabepilone and rifampin co-administration.
Secondary outcomes:
measure: 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
timeFrame: From Day 1 to 30 days after the last dose of study drug.
measure: Number of Participants With Grade 3-4 Hematology Abnormalities
timeFrame: Screening, Day 1, Day 8, Day 15, Day 22 and Day 29-36.
measure: Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Bilirubin, Albumin and Phosphorous
timeFrame: Screening, Days 1 and 22.
measure: Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Calcium, Magnesium, Potassium, Sodium, Glucose and Uric Acid.
timeFrame: Screening, Days 2 and 22.
measure: Number of Participants With Clinically Meaningful Vital Signs Measures
timeFrame: From screening to the off treatment visit.
measure: Number of Participants With Abnormal Physical Examination Findings
timeFrame: From screening to the off treatment visit.
measure: QT Interval Corrected for Heart Rate (QTcF)
timeFrame: Data collected at 0, 1.5, 3, 4, 6, 8 and 24 hours after start of infusion.
measure: Number of Participants With Identified ECG Abnormalities
timeFrame: Data collected at screening, Day -1 and Day 1 (at 0, 1.5, 3, 4, 6, 8 and 24 hours) after start of infusion.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: