- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00632424
Phase 1 Trial of Oral Ixabepilone
February 9, 2016 updated by: R-Pharm
A Phase 1 Study of Ixabepilone Administered as 3 Oral Doses Each Separated by 6 Hours Every 21 Days in Subjects With Advanced Cancer
This Phase 1 study of oral ixabepilone given every 6 hours for 3 doses on Day 1, every 21 days, was a dose-finding study designed to determine the maximum tolerated dose (MTD) and safety of this dosing schedule in participants with advanced cancer
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Georgetown University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males and females, 18 or older
- Histologically or cytologically confirmed diagnosis of solid tumor malignancy
- Measurable or non-measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
- Karnofsky Performance Status (KPS) of 70-100
- Recovered from toxicities resulting from previous therapies
Exclusion Criteria:
- More than 3 prior cytotoxic regimens in the metastatic setting
- Current or recent gastrointestinal (GI) disease that would impact the absorption of study drug
- Inability to swallow whole capsules
- Inadequate hepatic and renal function
- Function exposure to any epothilone
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
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Capsules, Oral, Dose escalating (Phase 1), 3 doses on 1 day every 3 weeks, until disease progression or unacceptable toxicity
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With a Dose-Limiting Toxicity (DLT)
Time Frame: During Cycle 1 (Day 0 through Day 21)
|
DLT: any of the following, considered related to ixabepilone, occurring in Cycle 1: Absolute neutrophil count (ANC) <500 cells/mm^3 for ≥5 consecutive days or febrile neutropenia of any duration; Grade(Gr)4 thrombocytopenia <25,000 cells/mm^3 or Gr3 with bleeding requiring platelet transfusion; Gr3/4 nausea, vomiting, or diarrhea despite use of adequate intervention, fatigue, any other clinically significant drug-related ≥Gr 3 non-hematologic toxicity, delayed recovery (to Gr ≤1 or baseline, except alopecia) from toxicity which delays initiation of Cycle 2 by ≥3 weeks.
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During Cycle 1 (Day 0 through Day 21)
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Ixabepilone Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD)
Time Frame: At the end of Cycle 1 (21 days).
|
The MTD was defined as the maximum dose which could be given to 6 participants such that not more than 1 participant experienced a DLT (or fewer than one-third if there were more than 6 treated participants) with at least 2 participants experiencing a DLT at the next higher dose level.
The R2PD was to be based on the MTD and the assessment of any relevant chronic toxicities.
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At the end of Cycle 1 (21 days).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Event (AE), AE Leading to Discontinuation, Treatment-related AE, Treatment-related AE Leading to Discontinuation (DC), Most Common Treatment-Related Nonhematologic AE (>25%), Serious AE (SAE), or Treatment-related SAE
Time Frame: From first study drug administration through 30 days post dose
|
AEs graded according to Common Terminology Criteria Version 3.0 (CTC v 3.0).
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment.
SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event.
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From first study drug administration through 30 days post dose
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Number of Participants With Most Common Treatment-Related Nonhematologic AEs (>25%)
Time Frame: From first study drug administration through 30 days post dose
|
AEs graded according to Common Terminology Criteria Version 3.0 (CTC v 3.0).
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment.
SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event.
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From first study drug administration through 30 days post dose
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Number of Participants With Hematology Laboratory Abnormalities
Time Frame: From first study drug administration through 30 days post dose
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Laboratory results were graded according to CTC v 3.0.
Hematology laboratory evaluations included absolute neutrophil count (ANC), white blood cell count (WBC), platelets (PLT), and hemoglobin (HGB).
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From first study drug administration through 30 days post dose
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Number Of Participants With Liver Function and Renal Laboratory Abnormalities
Time Frame: From first study drug administration through 30 days post dose
|
Laboratory results were graded according to CTC v 3.0.
Clinical laboratory evaluations included liver function (alanine aminotransferase [ALT], Aspartate aminotransferase [AST], alkaline phosphatase, and total bilirubin), and renal function (creatinine).
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From first study drug administration through 30 days post dose
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Maximum QTc Interval on Day 1 and Maximum Change From Baseline for QTc Interval
Time Frame: Baseline (Day -1) and Day 1
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QTc interval was defined as the measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, corrected for heart rate
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Baseline (Day -1) and Day 1
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PK: Mean Plasma Concentration Of Ixabepilone By Nominal Collection Time
Time Frame: Time 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 12.5, 13, 14, 15, 16, 17, 18, 20, 48, 72, and 168 hours post dose
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Pharmacokinetics (PK) of ixabepilone were derived from plasma concentration versus time data.
Individual patient PK parameter values were derived by standard non-compartmental methods by a validated pharmacokinetic analysis program.
PK parameters include Cmax (maximum plasma concentration), Cmin (minimum plasma concentration), Tmax (time of maximum plasma concentration), AUC (0-TAU) (area under the curve in one dosing interval), T-half (plasma half-life).
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Time 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 12.5, 13, 14, 15, 16, 17, 18, 20, 48, 72, and 168 hours post dose
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Best Overall Response
Time Frame: Tumor assessments performed on Day 1 of every other cycle of therapy, until disease progression or toxicity
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Tumor assessment was performed according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR) = disappearance of all clinical and radiological evidence of target lesions; Partial Response (PR) = at least 30% reduction in the sum of the longest diameter of all target lesions; Progressive disease (PD) = at least 20% increase in the sum of the longest diameter of all target lesions; Stable Disease (SD) = neither PR nor PD criteria were met.
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Tumor assessments performed on Day 1 of every other cycle of therapy, until disease progression or toxicity
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
March 3, 2008
First Submitted That Met QC Criteria
March 7, 2008
First Posted (Estimate)
March 10, 2008
Study Record Updates
Last Update Posted (Estimate)
March 10, 2016
Last Update Submitted That Met QC Criteria
February 9, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- CA163-149
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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