Clinical trial NCT00632424: Phase 1 Trial of Oral Ixabepilone
Official title: A Phase 1 Study of Ixabepilone Administered as 3 Oral Doses Each Separated by 6 Hours Every 21 Days in Subjects With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: R-Pharm
Sponsor class: INDUSTRY
First posted: 2008-03-10
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With a Dose-Limiting Toxicity (DLT)
timeFrame: During Cycle 1 (Day 0 through Day 21)
measure: Ixabepilone Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD)
timeFrame: At the end of Cycle 1 (21 days).
Secondary outcomes:
measure: 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
timeFrame: From first study drug administration through 30 days post dose
measure: Number of Participants With Most Common Treatment-Related Nonhematologic AEs (>25%)
timeFrame: From first study drug administration through 30 days post dose
measure: Number of Participants With Hematology Laboratory Abnormalities
timeFrame: From first study drug administration through 30 days post dose
measure: Number Of Participants With Liver Function and Renal Laboratory Abnormalities
timeFrame: From first study drug administration through 30 days post dose
measure: Maximum QTc Interval on Day 1 and Maximum Change From Baseline for QTc Interval
timeFrame: Baseline (Day -1) and Day 1
measure: PK: Mean Plasma Concentration Of Ixabepilone By Nominal Collection Time
timeFrame: 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
measure: Best Overall Response
timeFrame: Tumor assessments performed on Day 1 of every other cycle of therapy, until disease progression or toxicity
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: