A Phase I Study of Oral Ixabepilone in Subjects With Adva... | NCT00422097 | Trialant
NCT00422097
Sponsor
R-Pharm
Status
Completed
Last Update Posted
Mar 10, 2016Estimated
Enrollment
40Actual
Phase
Phase 1
Conditions
Cancer
Interventions
Ixabepilone, 5 mg/d
Ixabepilone, 10 mg/d
Ixabepilone, 15 mg/d
Ixabepilone, 20 mg/d
Ixabepilone, 25 mg/d
Ixabepilone, 30 mg/d
Ixabepilone, 25 mg, with famotidine
Ixabepilone, 25 mg, with food
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00422097
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA163-111
Secondary IDs
Not provided
Brief Title
A Phase I Study of Oral Ixabepilone in Subjects With Advanced Cancer
Official Title
A Phase I Study of Ixabepilone Administered as a Daily Oral Dose on 5 Successive Days Every 21 Days in Subjects With Advanced Cancer
Acronym
Not provided
Organization
R-PharmINDUSTRY
Status Module
Record Verification Date
Feb 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 2007
Primary Completion Date
Aug 2009Actual
Completion Date
Apr 2011Actual
First Submitted Date
Jan 12, 2007
First Submission Date that Met QC Criteria
Jan 12, 2007
First Posted Date
Jan 15, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 27, 2011
Results First Submitted that Met QC Criteria
Mar 24, 2011
Results First Posted Date
Apr 20, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 9, 2016
Last Update Posted Date
Mar 10, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
R-PharmINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This study will determine the maximum tolerated dose of oral ixabepilone administered for 5 successive days every 21 days in participants with advanced cancer. The safety, tolerability, and pharmacokinetics of ixabepilone in the body will be studied. In addition, this study will assess preliminary evidence of the effect of food and famotidine on the pharmacokinetics of oral ixabepilone.
Detailed Description
Not provided
Conditions Module
Conditions
Cancer
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
40Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Ixabepilone, 5 mg/d
Experimental
If none of first 3 participants experiences a dose-limiting toxicity (DLT) during the first 21-day cycle, a new cohort is opened at the next dose level (5-mg increments). If 2 or more of the first 3 participants experience a DLT within the first 21-day course, the dose level will be considered above the maximum tolerated dose (MTD). If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. If 2 or more of the 6 participants (or 1/3 or more of a cohort with more than 6 participants) experience a DLT, this dose level will be considered above the MTD.
Drug: Ixabepilone, 5 mg/d
Ixabepilone, 10 mg/d
Experimental
If none of first 3 participants experiences a DLT during the first 21-day cycle, a new cohort is opened at the next dose level (5-mg increments). If 2 or more of the first 3 participants experience a DLT within the first 21-day course, the dose level will be considered above the MTD. If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. If 2 or more of the 6 participants (or 1/3 or more of a cohort with more than 6 participants) experience a DLT, this dose level will be considered above the MTD.
Drug: Ixabepilone, 10 mg/d
Ixabepilone, 15 mg/d
Experimental
If none of first 3 participants experiences a DLT during the first 21-day cycle, a new cohort is opened at the next dose level (5-mg increments). If 2 or more of the first 3 participants experience a DLT within the first 21-day course, the dose level will be considered above the MTD. If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. If 2 or more of the 6 participants (or 1/3 or more of a cohort with more than 6 participants) experience a DLT, this dose level will be considered above the MTD.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ixabepilone, 5 mg/d
Drug
Ixabepilone, 5 mg, administered orally once daily on Days 1 through 5 every 21 days. Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal. No dose escalation within each treatment group. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Maximum Tolerated Dose (MTD) of Ixabepilone
MTD is based on Cycle 1 data only and defined as the maximum dose that can be administered to 6 participants with no more than 1 experiencing a dose-limiting toxicity (DLT) (or fewer than one third of participants if more than 6 receive treatment) with at least 2 participants experiencing a DLT at the next higher dose level. DLT=an event, such as neutropenia; thrombocytopenia; Gr 3 or 4 nausea or diarrhea; Gr 3 fatigue or asthenia; transient arthralgia or recalcitrant myalgia; and prolonged recovery from a toxicity, that occurs during the first course of treatment.
Days 1 through 21 (Cycle 1)
Number of Participants With DLTs by Worst Common Terminology Criteria (CTC) Grade
Adverse events (AEs) graded by CTC version 3. Grade (Gr) 1=mild; Gr 2=moderate; Gr 3=severe; Gr 4=life threatening; Gr 5=Death related to AE. DLT is defined as an event related to ixabepilone that occurs during the first course of treatment. Includes neutropenia; thrombocytopenia; Gr 3 or 4 nausea, vomiting, or diarrhea despite adequate medical intervention and prophylaxis; Gr 3 fatigue or asthenia; transient arthralgia or myalgia unresponsive to medical intervention; any Gr 3 nonhematologic toxicity; and prolonged recovery from a toxicity.
Days 1 through 21 (Cycle 1), continuously
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Death as Outcome, Treatment-related Adverse Events (AEs), and AEs Leading to Discontinuation
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of solid tumor malignancy unresponsive to current treatment options
Measurable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors
Lapse of at least 1 week since minor surgery and of at least 3 weeks since major surgery and radiation therapy
Eastern Cooperative Oncology Group performance status of 0-1
Lapse of at least 4 weeks since immunotherapy or chemotherapy
Negative pregnancy test result within 72 hours of study drug administration for any woman of childbearing potential (WOCBP)
Exclusion Criteria:
WOCBP unable or unwilling to use birth control during study and for up to 4 weeks after study completion
Women who are pregnant or breastfeeding
Fertile men not using effective birth control with partners who are WOCBP
Gastrointestinal(GI) disease or GI tract surgery that could impact drug absorption
Inability to swallow capsules
Inability to be venipunctured or to tolerate venous access
Known symptomatic brain metastases
Common Terminology Criteria for Adverse Events Grade 2 or greater neuropathy or history of Grade 3 or greater neuropathy
Psychiatric conditions inhibiting compliance with protocol requirements
Uncontrolled medical disorder or active infection that would impair participant's ability to receive protocol therapy or whose control may be jeopardized by the study treatment protocol
Inadequate hematologic, hepatic, or renal function
History of significant drug allergy
Previous exposure to ixabepilone
Exposure to any investigational drug or placebo within 4 weeks of enrollment
Concurrent chemotherapy regimen
Use of cytochrome P4503A4 inhibitors or inducers within 2 weeks of treatment initiation (unless approved by medical monitor)
Use of steroids (except as antiemetic)
Prisoners or subjects involuntarily detained for treatment
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Georgetown University Medical Center Lombardi Cancer Center
Washington D.C.
District of Columbia
20007
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Of 58 enrolled, 44 received treatment: 10 no longer met enrollment criteria (2 brain metastases, 2 bowel obstruction, 1 high aspartame aminotransferase [AST], 1 high AST/alanine transaminase, 2 low platelets, 1 hospitalized, 1 gastric adverse event [AE]); 2 withdrew consent/changed mind; 1 AE; 1 sponsor administrative reason.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Ixabepilone, 5 mg/d
Ixabepilone, 5 mg, given once daily in an oral dose on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a dose-limiting toxicity (DLT) in the first 21-day course, a new cohort is opened at the next dose level (10 mg/d). On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
Periods
Title
Milestones
Reasons Not Completed
Dose Level 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Ixabepilone, 15 mg/d
Ixabepilone, 20 mg/d
Experimental
If none of first 3 participants experiences a DLT during the first 21-day cycle, a new cohort is opened at the next dose level (5-mg increments). If 2 or more of the first 3 participants experience a DLT within the first 21-day course, the dose level will be considered above the MTD. If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. If 2 or more of the 6 participants (or 1/3 or more of a cohort with more than 6 participants) experience a DLT, this dose level will be considered above the MTD.
Drug: Ixabepilone, 20 mg/d
Ixabepilone, 25 mg/d
Experimental
If none of first 3 participants experiences a DLT during the first 21-day cycle, a new cohort is opened at the next dose level (5-mg increments). If 2 or more of the first 3 participants experience a DLT within the first 21-day course, the dose level will be considered above the MTD. If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. If 2 or more of the 6 participants (or 1/3 or more of a cohort with more than 6 participants) experience a DLT, this dose level will be considered above the MTD.
Drug: Ixabepilone, 25 mg/d
Ixabepilone, 30 mg/d
Experimental
If none of first 3 participants experiences a DLT during the first 21-day cycle, a new cohort is opened at the next dose level (5-mg increments). If 2 or more of the first 3 participants experience a DLT within the first 21-day course, the dose level will be considered above the MTD. If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. If 2 or more of the 6 participants (or 1/3 or more of a cohort with more than 6 participants) experience a DLT, this dose level will be considered above the MTD.
Drug: Ixabepilone, 30 mg/d
Ixabepilone, 25 mg, with famotidine
Experimental
Following identification of MTD, participants who completed Cycle 1 and treated at the ixabepilone MTD (25 mg/d) will crossover to Cycle 2 in which they receive famotidine, 40 mg on Day 1.
Drug: Ixabepilone, 25 mg, with famotidine
Ixabepilone, 25 mg, with food
Experimental
Following identification of MTD, participants who completed Cycle 1 and treated at the ixabepilone MTD (25 mg/d) will crossover to Cycle 2 in which they receive a low-fat meal on Day 1.
Drug: Ixabepilone, 25 mg, with food
Ixabepilone, 5 mg/d
Ixabepilone, 10 mg/d
Drug
Ixabepilone, 10 mg, administered orally once daily on Days 1 through 5 every 21 days. Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal. No dose escalation within each treatment group. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment.
Ixabepilone, 10 mg/d
Ixabepilone, 15 mg/d
Drug
Ixabepilone, 15 mg, administered orally once daily on Days 1 through 5 every 21 days. Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal. No dose escalation within each treatment group. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment.
Ixabepilone, 15 mg/d
Ixabepilone, 20 mg/d
Drug
Ixabepilone, 20 mg, administered orally once daily on Days 1 through 5 every 21 days. Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal. No dose escalation within each treatment group. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment.
Ixabepilone, 20 mg/d
Ixabepilone, 25 mg/d
Drug
Ixabepilone, 25 mg, administered orally once daily on Days 1 through 5 every 21 days. Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal. No dose escalation within each treatment group. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment.
Ixabepilone, 25 mg/d
Ixabepilone, 30 mg/d
Drug
Ixabepilone, 30 mg, administered orally once daily on Days 1 through 5 every 21 days. Dose increased by 5 mg for each subsequent treatment group until disease progression, unacceptable toxicity, or participant refusal. No dose escalation within each treatment group. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment.
Ixabepilone, 30 mg/d
Ixabepilone, 25 mg, with famotidine
Drug
Participants crossed over from Cycle 1 to receive famotidine, 40 mg, in an oral dose given 2 hours before ixabepilone, 25 mg, on Day 1 of Cycle 2 only.
Ixabepilone, 25 mg, with famotidine
Ixabepilone, 25 mg, with food
Drug
Participants consume a low-fat meal starting 30 minutes before dose administration on Day 1 of Cycle 2. Food consumed within 30 minutes. Administration of the total oral dose should not exceed more than 10 minutes from start to finish.
Ixabepilone, 25 mg, with food
Days 1 through 21 (Cycle 1), continuously
Number of Participants With Abnormal Laboratory Values by Worst CTC Grade
Lower limit of normal (LLN)=lowest level of normal among all laboratory ranges. Hemoglobin (g/dL): Gr 1: 10.0-\
Baseline and Days 1, 8, and 15 of Cycle 1 (21 days)
Maximum Plasma Concentration (Cmax) of Ixabepilone
Days 1 and 5 of Cycle 1
Time of Maximum Plasma Concentration (Tmax) of Ixabepilone
Days 1 and 5 of Cycle 1
Area Under the Concentration-time Curve in 1 Dosing Interval (AUC[TAU])of Ixabepilone
Days 1 and 5 of Cycle 1
Plasma Half-life (T-Half) of Ixabepilone
Day 5 of Cycle 1
Maximum Plasma Concentration (Cmax) of Oral Ixabepilone at MTD in Fasted and Fed Participants in Crossover Cohorts
After the MTD has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they consume a standard lowfat meal starting 30 minutes prior to ixabepilone, 25 mg, administration on Day 1 of Cycle 2 only. Meal is consumed within a 30-minute period. Administration of the total oral dose should not exceed more than 10 minutes from start to finish.
Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)
Time of Maximum Plasma Concentration (Tmax)of Oral Ixabepilone at MTD in Fasted and Fed Participants in Crossover Cohorts
After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they consume a standard lowfat meal starting 30 minutes prior to ixabepilone, 25 mg, administration on Day 1 of Cycle 2 only. Meal is consumed within a 30-minute period. Administration of the total oral dose should not exceed more than 10 minutes from start to finish.
Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)
Area Under the Curve in 1 Dosing Interval (AUC[TAU]) of Oral Ixabepilone at MTD in Fasted and Fed Participants in Crossover Cohorts
After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they consume a standard lowfat meal starting 30 minutes prior to ixabepilone, 25 mg, administration on Day 1 of Cycle 2 only. Meal is consumed within a 30-minute period. Administration of the total oral dose should not exceed more than 10 minutes from start to finish.
Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)
Maximum Plasma Concentration (Cmax) of Oral Ixabepilone With and Without Famotidine in Crossover Cohorts
After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they receive famotidine, 40 mg. Prior to dosing on Day 1 of Cycle 2, famotidine administered in an oral dose 2 hours before ixabepilone 25-mg dose.
Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)
Time of Maximum Plasma Concentration (Tmax) of Oral Ixabepilone With and Without Famotidine in Crossover Cohorts
After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they receive famotidine, 40 mg. Prior to dosing on Day 1 of Cycle 2, famotidine administered in an oral dose 2 hours before ixabepilone 25-mg dose.
Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)
Area Under the Curve in 1 Dosing Interval (AUC[TAU]) of Oral Ixabepilone With and Without Famotidine in Crossover Cohorts
After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given alone once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they receive famotidine, 40 mg. Prior to dosing on Day 1 of Cycle 2, famotidine administered in an oral dose 2 hours before ixabepilone 25-mg dose.
Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)
Number of Participants With Significant Findings on Physical Examination or Electrocardiogram (ECG)
Physical examination evaluated height, weight, Eastern Cooperative Oncology Group performance status, adverse events, and abnormal laboratory findings and included a neurologic examination to evaluate deep tendon reflexes, sensory modalities, and motor strength. Participants also underwent a 12-lead ECG screening. Physical examination findings and ECG findings were considered clinically significant at the investigator's discretion.
At screening and predose Day 1, Cycle 1 (21 days)
Number of Participants With Abnormal (CTC Grade 3 or Greater) Serum Chemistry Levels
Upper limit of normal (ULN)=upper level of normal among all laboratory ranges. Alkaline phosphatase(U/L): Gr 3: >5.0-20.0*ULN; Gr 4: >20.0*ULN. Sodium (mEq/L): Gr 3: 120-<130 or >155-160; Gr 4 <120. Potassium (mEq/L): Gr 3: 2.5-<3.0 or >6.0-7.0; Gr 4: <2.5 or >7.0. Calcium (mg/dL): Gr 3: 6.0-<7.0 or >12.5-13.5; Gr 4: <6.0 or >13.5. Inorganic phosphorus (mg/dL): Gr 3: 1.0-<2.0; Gr 4: <1.0. Albumin (g/dL): Gr 3: <2.0.
At screening and predose Day 1, Cycle 1 (21 days)
Wayne State University (Hwcrc)
Detroit
Michigan
48201
United States
FG001
Ixabepilone, 10 mg/d
Ixabepilone, 10 mg, given once daily in an oral dose on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a DLT during the first 21-day course, a new cohort is opened at the next dose level (15 mg/d). If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
FG002
Ixabepilone, 15 mg/d
Ixabepilone, 15 mg, given once daily in an oral dose on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a DLT during the first 21-day course, a new cohort is opened at the next dose level (20 mg/d). If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
FG003
Ixabepilone, 20 mg/d
Ixabepilone, 20 mg, given daily in oral doses on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a DLT during the first 21-day course, a new cohort is opened at the next dose level (25 mg/d). On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
FG004
Ixabepilone, 25 mg/d
Ixabepilone, 25 mg/d, given once daily in an oral dose on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a DLT in the first 21-day course, a new cohort is opened at the next dose level (30 mg/d). If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. If 2 or more of the 6 participants (or 1/3 or more of a cohort with more than 6 participants) experience a DLT, this dose level will be considered above the MTD. The MTD is the maximum dose that can be given to 6 participants without producing a DLT in more than 1 participant (or fewer than 1/3 if the cohort has more than 6 participants). More participants may be enrolled at any level to provide additional safety data. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
FG005
Ixabepilone, 30 mg/d
Ixabepilone, 30 mg, given daily orally on Days 1 through 5 every 21 days. If 2 or more of the first 3 participants experience a DLT within the first 21-day course, this dose level will be considered above the MTD. If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. If 2 or more of the 6 participants (or 1/3 or more of a cohort with more than 6 participants) experience a DLT, this dose level will be considered above the MTD (the maximum dose that can be given to 6 participants without producing a DLT in more than 1 [or fewer than 1/3 if more than 6 participants in cohort)]. On all dosing days in Cycle 1, participants to fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
FG006
Ixabepilone, MTD (25 mg), With Famotidine
Cohort opened for Cycle 2, once ixabepilone MTD (25 mg) determined. In Cycle 1, participants received ixabepilone, 25 mg, alone, orally once per day on Days 1 through 21. Then participants crossed over to receive famotidine wirh ixabepilone in Cycle 2. Prior to dosing on Day 1 of Cycle 2, famotidine, 40 mg, administered in an oral dose 2 hours before ixabepilone 25-mg dose.
FG007
Ixabepilone, MTD (25 mg), With Food
Cohort opened for Cycle 2, after ixabepilone MTD (25 mg) determined. In Cycle 1, participants received ixabepilone, 25 mg, once daily in an oral dose on Days 1 through 5. On all dosing days in Cycle 1, participants fasted at least 4 hours before and 4 hours after dosing. Then participants crossed over to Cycle 2. On Day 1 of Cycle 2, participants allowed a low-fat meal. Participants ingest the specified meal within a 30-minute period and receive ixabepilone, 25 mg, 30 minutes after start of the meal. For the duration of Cycle 2, participants fast 1 hour before and 2 hours after ixabepilone dose.
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Dose Level 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0016 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG0000 subjects
FG0015 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Still on treatment
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG003
Dose Level 3
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Dose Level 4
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Dose Level 5
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00423 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Dose Level 6
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0056 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Ixabepilone With Famotidine or Food
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0068 subjects
FG0077 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Ixabepilone, 5 mg/d
Participants with advanced cancer received daily oral doses of ixabepilone, 5 mg, on Days 1 through 5 every 21 days.
BG001
Ixabepilone, 10 mg/d
Participants with advanced cancer received daily oral doses of ixabepilone, 10 mg, on Days 1 through 5 every 21 days.
BG002
Ixabepilone, 15 mg/d
Participants with advanced cancer received daily oral doses of ixabepilone, 15 mg, on Days 1 through 5 every 21 days.
BG003
Ixabepilone, 20 mg/d
Participants with advanced cancer received daily oral doses of ixabepilone, 20 mg, on Days 1 through 5 every 21 days.
BG004
Ixabepilone, 25 mg/d
Participants with advanced cancer received daily oral doses of ixabepilone, 25 mg, on Days 1 through 5 every 21 days.
BG005
Ixabepilone, 30 mg/d
Participants with advanced cancer received daily oral doses of ixabepilone, 30 mg, on Days 1 through 5 every 21 days.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0016
BG0023
BG0033
BG00423
BG0056
BG00644
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00064(44 to 76)
BG00162(43 to 72)
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0013
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Secondary
Number of Participants With Death as Outcome, Treatment-related Adverse Events (AEs), and AEs Leading to Discontinuation
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment.
All Treated Subjects: All subjects who received at least 1 dose of ixabepilone.
Posted
Number
Participants
Days 1 through 21 (Cycle 1), continuously
ID
Title
Description
OG000
Ixabepilone, 5 mg/d
Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG001
Ixabepilone, 10 mg/d
Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG002
Ixabepilone, 15 mg/d
Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG003
Ixabepilone, 20 mg/d
Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG004
Ixabepilone, 25 mg/d
Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG005
Ixabepilone, 30 mg/d
Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
Units
Counts
Participants
OG0003
OG0016
OG0023
OG003
Title
Denominators
Categories
Death
Title
Measurements
OG0000
OG0010
OG0022
OG003
Primary
Maximum Tolerated Dose (MTD) of Ixabepilone
MTD is based on Cycle 1 data only and defined as the maximum dose that can be administered to 6 participants with no more than 1 experiencing a dose-limiting toxicity (DLT) (or fewer than one third of participants if more than 6 receive treatment) with at least 2 participants experiencing a DLT at the next higher dose level. DLT=an event, such as neutropenia; thrombocytopenia; Gr 3 or 4 nausea or diarrhea; Gr 3 fatigue or asthenia; transient arthralgia or recalcitrant myalgia; and prolonged recovery from a toxicity, that occurs during the first course of treatment.
All Treated Subjects: All subjects who received at least one dose of ixabepilone were included.
Posted
Number
mg/d
Days 1 through 21 (Cycle 1)
ID
Title
Description
OG000
All Treated Participants
Participants received daily oral doses of ixabepilone on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
Units
Counts
Participants
OG000
Secondary
Number of Participants With Abnormal Laboratory Values by Worst CTC Grade
Lower limit of normal (LLN)=lowest level of normal among all laboratory ranges. Hemoglobin (g/dL): Gr 1: 10.0-\
All Treated Subjects: All subjects who received at least one dose of ixabepilone were included.
Posted
Number
Participants
Baseline and Days 1, 8, and 15 of Cycle 1 (21 days)
ID
Title
Description
OG000
All Treated Participants
Participants received daily oral doses of ixabepilone on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
Units
Counts
Participants
Primary
Number of Participants With DLTs by Worst Common Terminology Criteria (CTC) Grade
Adverse events (AEs) graded by CTC version 3. Grade (Gr) 1=mild; Gr 2=moderate; Gr 3=severe; Gr 4=life threatening; Gr 5=Death related to AE. DLT is defined as an event related to ixabepilone that occurs during the first course of treatment. Includes neutropenia; thrombocytopenia; Gr 3 or 4 nausea, vomiting, or diarrhea despite adequate medical intervention and prophylaxis; Gr 3 fatigue or asthenia; transient arthralgia or myalgia unresponsive to medical intervention; any Gr 3 nonhematologic toxicity; and prolonged recovery from a toxicity.
All Treated Participants: All participants who received at least one dose of ixabepilone were included.
Posted
Number
Participants
Days 1 through 21 (Cycle 1), continuously
ID
Title
Description
OG000
Ixabepilone, 5 mg/d
Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG001
Ixabepilone, 10 mg/d
Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
Secondary
Maximum Plasma Concentration (Cmax) of Ixabepilone
All participants who received ixabepilone and who had adequate concentration profiles
Posted
Mean
Standard Deviation
ng/mL
Days 1 and 5 of Cycle 1
ID
Title
Description
OG000
Ixabepilone, 5 mg/d
All participants who received ixabepilone and who had adequate concentration profiles were included.
OG001
Ixabepilone, 10 mg/d
All participants who received ixabepilone and who had adequate concentration profiles were included.
OG002
Ixabepilone, 15 mg/d
All participants who received ixabepilone and who had adequate concentration profiles were included.
OG003
Ixabepilone, 20 mg/d
All participants who received ixabepilone and who had adequate concentration profiles were included.
OG004
Ixabepilone, 25 mg/d
Secondary
Time of Maximum Plasma Concentration (Tmax) of Ixabepilone
All participants who received ixabepilone and who had adequate concentration profiles
Posted
Median
Full Range
Hour
Days 1 and 5 of Cycle 1
ID
Title
Description
OG000
Ixabepilone, 5 mg/d
Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG001
Ixabepilone, 10 mg/d
Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG002
Ixabepilone, 15 mg/d
Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
Secondary
Area Under the Concentration-time Curve in 1 Dosing Interval (AUC[TAU])of Ixabepilone
All participants who received ixabepilone and who had adequate concentration profiles.
Posted
Mean
Standard Deviation
ng*h/mL
Days 1 and 5 of Cycle 1
ID
Title
Description
OG000
Ixabepilone, 5 mg/d
Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG001
Ixabepilone, 10 mg/d
Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG002
Ixabepilone, 15 mg/d
Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
Secondary
Plasma Half-life (T-Half) of Ixabepilone
All participants who received ixabepilone and who had adequate concentration profiles
Posted
Mean
Standard Deviation
Hours
Day 5 of Cycle 1
ID
Title
Description
OG000
Ixabepilone, 5 mg/d
Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG001
Ixabepilone, 10 mg/d
Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG002
Ixabepilone, 15 mg/d
Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
Secondary
Maximum Plasma Concentration (Cmax) of Oral Ixabepilone at MTD in Fasted and Fed Participants in Crossover Cohorts
After the MTD has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they consume a standard lowfat meal starting 30 minutes prior to ixabepilone, 25 mg, administration on Day 1 of Cycle 2 only. Meal is consumed within a 30-minute period. Administration of the total oral dose should not exceed more than 10 minutes from start to finish.
All participants who received ixabepilone and who had adequate concentration profiles. Participants received MTD (25 mg) ixabepilone without famotidine (Cycle 1) and then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine (Cycle 2).
Posted
Mean
Standard Deviation
ng/mL
Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)
ID
Title
Description
OG000
Ixabepilone, 25 mg/d
Units
Counts
Participants
OG000
Secondary
Time of Maximum Plasma Concentration (Tmax)of Oral Ixabepilone at MTD in Fasted and Fed Participants in Crossover Cohorts
After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they consume a standard lowfat meal starting 30 minutes prior to ixabepilone, 25 mg, administration on Day 1 of Cycle 2 only. Meal is consumed within a 30-minute period. Administration of the total oral dose should not exceed more than 10 minutes from start to finish.
All participants who received ixabepilone and who had adequate concentration profiles. Participants received MTD (25 mg).
Posted
Median
Full Range
ng/mL
Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)
ID
Title
Description
OG000
Ixabepilone, 25 mg/d
Units
Counts
Participants
OG000
Secondary
Area Under the Curve in 1 Dosing Interval (AUC[TAU]) of Oral Ixabepilone at MTD in Fasted and Fed Participants in Crossover Cohorts
After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they consume a standard lowfat meal starting 30 minutes prior to ixabepilone, 25 mg, administration on Day 1 of Cycle 2 only. Meal is consumed within a 30-minute period. Administration of the total oral dose should not exceed more than 10 minutes from start to finish.
All participants who received ixabepilone and who had adequate concentration profiles. Participants received MTD (25 mg).
Posted
Mean
Standard Deviation
ng*h/mL
Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)
ID
Title
Description
OG000
Ixabepilone, 25 mg/d
Units
Counts
Participants
OG000
Secondary
Maximum Plasma Concentration (Cmax) of Oral Ixabepilone With and Without Famotidine in Crossover Cohorts
After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they receive famotidine, 40 mg. Prior to dosing on Day 1 of Cycle 2, famotidine administered in an oral dose 2 hours before ixabepilone 25-mg dose.
Participants who received ixabepilone, at the MTD of 25 mg, alone in Cycle 1 and had adequate concentration profiles. Participants then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine,40 mg, on Day 1 of Cycle 2.
Posted
Mean
Standard Deviation
ng/mL
Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)
ID
Title
Description
OG000
Ixabepilone, 25 mg/d
Units
Counts
Participants
OG000
Secondary
Time of Maximum Plasma Concentration (Tmax) of Oral Ixabepilone With and Without Famotidine in Crossover Cohorts
After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they receive famotidine, 40 mg. Prior to dosing on Day 1 of Cycle 2, famotidine administered in an oral dose 2 hours before ixabepilone 25-mg dose.
Participants who received ixabepilone, at the MTD of 25 mg, alone in Cycle 1 and had adequate concentration profiles. Participants then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine,40 mg, on Day 1 of Cycle 2.
Posted
Median
Full Range
ng/mL
Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)
ID
Title
Description
OG000
Ixabepilone, 25 mg/d
Participants received MTD (25 mg) ixabepilone without famotidine (Cycle 1) and then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone (with famotidine (Cycle 2). On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after ixabepilone treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
Units
Counts
Secondary
Area Under the Curve in 1 Dosing Interval (AUC[TAU]) of Oral Ixabepilone With and Without Famotidine in Crossover Cohorts
After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given alone once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they receive famotidine, 40 mg. Prior to dosing on Day 1 of Cycle 2, famotidine administered in an oral dose 2 hours before ixabepilone 25-mg dose.
Participants who received ixabepilone, at the MTD of 25 mg, alone in Cycle 1 and had adequate concentration profiles. Participants then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine,40 mg, on Day 1 of Cycle 2.
Posted
Mean
Standard Deviation
ng*h/mL
Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)
ID
Title
Description
OG000
Ixabepilone, 25 mg/d
Participants who received MTD (25 mg) ixabepilone without famotidine and then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine. Fasted/Fed criteria: Cycle 1: Dose 1 administered after a minimum of a 4-hour fast. Cycle 2: Dose 1 administered with a low-fat meal to crossover cohort.
Units
Counts
Participants
Secondary
Number of Participants With Significant Findings on Physical Examination or Electrocardiogram (ECG)
Physical examination evaluated height, weight, Eastern Cooperative Oncology Group performance status, adverse events, and abnormal laboratory findings and included a neurologic examination to evaluate deep tendon reflexes, sensory modalities, and motor strength. Participants also underwent a 12-lead ECG screening. Physical examination findings and ECG findings were considered clinically significant at the investigator's discretion.
Although physical examinations and ECGs were performed, the findings were not summarized.
Posted
Number
Participants
At screening and predose Day 1, Cycle 1 (21 days)
ID
Title
Description
OG000
Ixabepilone, 5 mg/d
Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG001
Ixabepilone, 10 mg/d
Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
Secondary
Number of Participants With Abnormal (CTC Grade 3 or Greater) Serum Chemistry Levels
Upper limit of normal (ULN)=upper level of normal among all laboratory ranges. Alkaline phosphatase(U/L): Gr 3: >5.0-20.0*ULN; Gr 4: >20.0*ULN. Sodium (mEq/L): Gr 3: 120-<130 or >155-160; Gr 4 <120. Potassium (mEq/L): Gr 3: 2.5-<3.0 or >6.0-7.0; Gr 4: <2.5 or >7.0. Calcium (mg/dL): Gr 3: 6.0-<7.0 or >12.5-13.5; Gr 4: <6.0 or >13.5. Inorganic phosphorus (mg/dL): Gr 3: 1.0-<2.0; Gr 4: <1.0. Albumin (g/dL): Gr 3: <2.0.
All Treated Subjects: All subjects who received at least one dose of ixabepilone were included.
Posted
Number
Participants
At screening and predose Day 1, Cycle 1 (21 days)
ID
Title
Description
OG000
All Treated Participants
Participants received daily oral doses of ixabepilone on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
Units
Counts
Participants
OG000
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Ixabepilone, 5 mg
Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days
0
3
3
3
EG001
Ixabepilone, 10 mg
Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days
2
6
6
6
EG002
Ixabepilone, 15 mg
Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days
3
3
3
3
EG003
Ixabepilone, 20 mg
Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days
1
3
2
3
EG004
Ixabepilone, 25 mg
Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days
6
23
20
23
EG005
Ixabepilone, 30 mg
Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days
5
6
6
6
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Myocardial infarction
Cardiac disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected23 at risk
EG0050 affected6 at risk
Ileus
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected6 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Diarrhea
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Gastrointestinal hemorrhage
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Infection
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected6 at risk
EG0022 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Catheter-related infection
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Hypokalemia
Metabolism and nutrition disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0021 affected3 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Chest pain
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Sudden death
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Noncardiac chest pain
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Tumor hemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Nonsmall cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Weight decreased
Investigations
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected23 at risk
EG0051 affected6 at risk
Culture urine positive
Investigations
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 12.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Aphonia
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected6 at risk
EG0021 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected6 at risk
EG0022 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected6 at risk
EG0023 affected3 at risk
EG003
Diarrhea
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected6 at risk
EG0021 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0021 affected3 at risk
EG003
Abdominal mass
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Gastrointestinal hemorrhage
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Gastroesophogeal reflux disease
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Candidiasis
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Oncyhomyocosis
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0021 affected3 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Urethral stenosis
Renal and urinary disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0022 affected3 at risk
EG003
Hypokalemia
Metabolism and nutrition disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Hypocalcemia
Metabolism and nutrition disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Hyponatremia
Metabolism and nutrition disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Hypomagnesemia
Metabolism and nutrition disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Hypophosphatemia
Metabolism and nutrition disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected6 at risk
EG0021 affected3 at risk
EG003
Anemia
Blood and lymphatic system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected6 at risk
EG0021 affected3 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Exfoliative rash
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Trismus
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0002 affected3 at risk
EG0013 affected6 at risk
EG0020 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Dyspnea
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Rhinorrhea
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected6 at risk
EG0020 affected3 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Pain
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0021 affected3 at risk
EG003
Chills
General disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Edema
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 12.1
Systematic Assessment
EG0002 affected3 at risk
EG0014 affected6 at risk
EG0021 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0014 affected6 at risk
EG0021 affected3 at risk
EG003
Chest pain
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Gait disturbance
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Implant site pain
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Edema peripheral
General disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected6 at risk
EG0020 affected3 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Noncardiac chest pain
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected6 at risk
EG0020 affected3 at risk
EG003
Acrohordon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected6 at risk
EG0020 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period \
Point of Contact
Title
Organization
Phone
Extension
Email
BMS Study Director
Bristol-Myers Squibb
Clinical.Trials@bms.com
ID
Term
D009369
Neoplasms
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C430592
ixabepilone
D015738
Famotidine
D005502
Food
Ancestor Terms
ID
Term
D013844
Thiazoles
D013457
Sulfur Compounds
D009930
Organic Chemicals
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D000066888
Diet, Food, and Nutrition
D010829
Physiological Phenomena
D019602
Food and Beverages
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
23 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0056 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0068 subjects
FG0077 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0
BG0040
BG0050
BG0060
Between 18 and 65 years
BG0001
BG0013
BG0022
BG0032
BG00421
BG0053
BG00632
>=65 years
BG0002
BG0013
BG0021
BG0031
BG0042
BG0053
BG00612
60
(50 to 74)
BG00360(49 to 73)
BG00456(40 to 78)
BG00569(63 to 83)
BG00660(40 to 83)
2
BG0032
BG00412
BG0052
BG00623
Male
BG0001
BG0013
BG0021
BG0031
BG00411
BG0054
BG00621
0
BG0030
BG0041
BG0050
BG0061
Asian
BG0000
BG0010
BG0020
BG0030
BG0043
BG0050
BG0063
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Black or African American
BG0000
BG0011
BG0021
BG0030
BG0042
BG0050
BG0064
White
BG0003
BG0015
BG0022
BG0033
BG00417
BG0056
BG00636
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
3
OG00423
OG0056
1
OG0041
OG0051
Treatment-related AEs
Title
Measurements
OG0002
OG0016
OG0023
OG0031
OG00412
OG0055
AEs
Title
Measurements
OG0003
OG0016
OG0023
OG0032
OG00420
OG0056
AEs leading to discontinuation
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0041
OG0050
44
Title
Denominators
Categories
Title
Measurements
OG00025
OG00044
Title
Denominators
Categories
Hemoglobin (Grade 1)
Title
Measurements
OG00019
Hemoglobin (Grade 2)
Title
Measurements
OG00015
Hemoglobin (Grade 3)
Title
Measurements
OG0005
Hemoglobin (Grade 4)
Title
Measurements
OG0000
Leukocytes (Grade 1)
Title
Measurements
OG0007
Leukocytes (Grade 2)
Title
Measurements
OG0004
Leukocytes (Grade 3)
Title
Measurements
OG0002
Leukocytes (Grade 4)
Title
Measurements
OG0003
Lymphocytes (Absolute) (Grade 1)
Title
Measurements
OG00014
Lymphocytes (Absolute) (Grade 2)
Title
Measurements
OG00014
Lymphocytes (Absolute) (Grade 3)
Title
Measurements
OG00012
Lymphocytes (Absolute) (Grade 4)
Title
Measurements
OG0003
Neutrophils (Absolute) (Grade 1)
Title
Measurements
OG0003
Neutrophils (Absolute) (Grade 2)
Title
Measurements
OG0000
Neutrophils (Absolute) (Grade 3)
Title
Measurements
OG0001
Neutrophils (Absolute) (Grade 4)
Title
Measurements
OG0004
Neutrophils + Bands (Absolute) (Grade 1)
Title
Measurements
OG0003
Neutrophils + Bands (Absolute) (Grade 2)
Title
Measurements
OG0000
Neutrophils + Bands (Absolute) (Grade 3)
Title
Measurements
OG0001
Neutrophils + Bands (Absolute) (Grade 4)
Title
Measurements
OG0004
Platelet Count (Grade 1)
Title
Measurements
OG0003
Platelet Count (Grade 2)
Title
Measurements
OG0003
Platelet Count (Grade 3)
Title
Measurements
OG0001
Platelet Count (Grade 4)
Title
Measurements
OG0001
OG002
Ixabepilone, 15 mg/d
Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG003
Ixabepilone, 20 mg/d
Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG004
Ixabepilone, 25 mg/d
Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG005
Ixabepilone, 30 mg/d
Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
Units
Counts
Participants
OG0003
OG0016
OG0023
OG0033
OG00423
OG0056
Title
Denominators
Categories
Clostridium difficile colitis (Grade 3)
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
Ileus (Grade 3)
Title
Measurements
OG0000
OG0011
OG0020
OG003
Abdominal pain (Grade 3)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Fatigue (Grade 3)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutropenic fever (Grade 3)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutropenic fever (Grade 4)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Dehydration (Grade 3)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Diarrhea (Grade 3)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypokalemia (Grade 3)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Nausea (Grade 3)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Vomiting (Grade 3)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Mucosal inflammation (Grade 3)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutropenia (Grade 4)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypokalemia (Grade 4)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypophosphatemia (Grade 4)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Thrombocytopenia (Grade 4)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sudden death (Grade 5)
Title
Measurements
OG0000
OG0010
OG0020
OG003
All participants who received ixabepilone and who had adequate concentration profiles were included.
OG005
Ixabepilone, 30 mg/d
All participants who received ixabepilone and who had adequate concentration profiles were included.
Units
Counts
Participants
OG0003
OG0016
OG0023
OG0033
OG00423
OG0056
Title
Denominators
Categories
Day1 (n=3, n=6, n=3, n=3, n=23, n=6)
Title
Measurements
OG0004.02± 1.99
OG00125.93± 20.47
OG00216.04± 16.76
OG00324.10± 19.96
OG00436.14± 25.18
OG00543.67± 20.87
Day 5 (n=2, n=6, n=3, n=3, n=22, n=6)
Title
Measurements
OG0002.45± 0.42
OG00120.34± 23.07
OG00222.17± 12.40
OG003
OG003
Ixabepilone, 20 mg/d
Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG004
Ixabepilone, 25 mg/d
Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG005
Ixabepilone, 30 mg/d
Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
Units
Counts
Participants
OG0003
OG0016
OG0023
OG0033
OG00423
OG0056
Title
Denominators
Categories
Day1 (n=3, n=6, n=3, n=3, n=23, n=6)
Title
Measurements
OG0002.0(1.0 to 2.0)
OG0011.8(1.0 to 3.0)
OG0024.0(2.0 to 4.0)
OG0032.0(2.0 to 3.0)
OG0042.0(0.5 to 24.0)
OG0053.0(1.5 to 4.0)
Day 5 (n=2, n=6, n=3, n=3, n=22, n=6)
Title
Measurements
OG0002.3(1.5 to 3.0)
OG0012.5(1.0 to 5.0)
OG0025.0(1.5 to 6.0)
OG003
OG003
Ixabepilone, 20 mg/d
Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG004
Ixabepilone, 25 mg/d
Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG005
Ixabepilone, 30 mg/d
Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
Units
Counts
Participants
OG0003
OG0016
OG0023
OG0033
OG00423
OG0056
Title
Denominators
Categories
Day 1 (n=3, n=6, n=3, n=3, n=23, n=6)
Title
Measurements
OG00028.40± 29.73
OG00191.79± 62.45
OG002120.58± 152.23
OG003120.82± 73.62
OG004195.96± 177.39
OG005252.01± 153.26
Day 5 (n=2, n=6, n=3, n=3, n=22, n=6)
Title
Measurements
OG00021.83± 28.59
OG001143.85± 134.15
OG002179.82± 126.95
OG003
OG003
Ixabepilone, 20 mg/d
Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG004
Ixabepilone, 25 mg/d
Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG005
Ixabepilone, 30 mg/d
Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
Units
Counts
Participants
OG0002
OG0016
OG0023
OG0033
OG00422
OG0056
Title
Denominators
Categories
Title
Measurements
OG00018.56± NAOnly 2 participants in this Arm on Day 5, so SD is not appropriate.
OG00147.00± 82.68
OG00224.32± 17.68
OG00335.25± 20.63
OG00435.62± 17.48
OG00534.14± 14.16
8
Title
Denominators
Categories
Fasted (Cycle 1)
Title
Measurements
OG00038.11± 29.48
Fed (Cycle 2)
Title
Measurements
OG00044.76± 38.69
8
Title
Denominators
Categories
Fasted (Cycle 1)
Title
Measurements
OG0002.0(0.5 to 5.0)
Fed (Cycle 2)
Title
Measurements
OG0004.0(2.0 to 6.0)
8
Title
Denominators
Categories
Fasted (Cycle 1)
Title
Measurements
OG000190.22± 128.14
Fed (Cycle 2)
Title
Measurements
OG000243.46± 99.91
7
Title
Denominators
Categories
Without Famotidine (Cycle 1)
Title
Measurements
OG00036.91± 29.79
With Famotidine (Cycle 2)
Title
Measurements
OG00066.16± 63.91
Participants
OG0007
Title
Denominators
Categories
Without Famotidine (Cycle 1)
Title
Measurements
OG0003.0(1.0 to 24.0)
With Famotidine (Cycle 2)
Title
Measurements
OG0004.0(2.0 to 6.0)
OG0007
Title
Denominators
Categories
Without Famotidine (Cycle 1)
Title
Measurements
OG000218.36± 260.55
With Famotidine (Cycle 2)
Title
Measurements
OG000276.30± 179.20
OG002
Ixabepilone, 15 mg/d
Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG003
Ixabepilone, 20 mg/d
Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG004
Ixabepilone, 25 mg/d
Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
OG005
Ixabepilone, 30 mg/d
Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.