Phase 1
Completed N=3
A Phase I Study of Oral Ixabepilone in Subjects With Advanced Cancer
Source: ClinicalTrials.gov NCT00422097 ↗Enrolled (actual)
3
Serious AEs
38.6%
Results posted
Apr 2011
Primary outcomePrimary: Maximum Tolerated Dose (MTD) of Ixabepilone — 25 mg/d
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of Ixabepilone |
25 | — |
| PRIMARY Number of Participants With DLTs by Worst Common Terminology Criteria (CTC) Grade |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Death as Outcome, Treatment-related Adverse Events (AEs), and AEs Leading to Discontinuation |
0; 0; 2; 1; 1; 1 | — |
| SECONDARY Number of Participants With Abnormal Laboratory Values by Worst CTC Grade |
19; 15; 5; 0; 7; 4 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Ixabepilone |
4.02; 25.93; 16.04; 24.10; 36.14; 43.67 | — |
| SECONDARY Time of Maximum Plasma Concentration (Tmax) of Ixabepilone |
2.0; 1.8; 4.0; 2.0; 2.0; 3.0 | — |
| SECONDARY Area Under the Concentration-time Curve in 1 Dosing Interval (AUC[TAU])of Ixabepilone |
28.40; 91.79; 120.58; 120.82; 195.96; 252.01 | — |
| SECONDARY Plasma Half-life (T-Half) of Ixabepilone |
18.56; 47.00; 24.32; 35.25; 35.62; 34.14 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Oral Ixabepilone at MTD in Fasted and Fed Participants in Crossover Cohorts |
38.11; 44.76 | — |
| SECONDARY Time of Maximum Plasma Concentration (Tmax)of Oral Ixabepilone at MTD in Fasted and Fed Participants in Crossover Cohorts |
2.0; 4.0 | — |
| SECONDARY Area Under the Curve in 1 Dosing Interval (AUC[TAU]) of Oral Ixabepilone at MTD in Fasted and Fed Participants in Crossover Cohorts |
190.22; 243.46 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Oral Ixabepilone With and Without Famotidine in Crossover Cohorts |
36.91; 66.16 | — |
| SECONDARY Time of Maximum Plasma Concentration (Tmax) of Oral Ixabepilone With and Without Famotidine in Crossover Cohorts |
3.0; 4.0 | — |
| SECONDARY Area Under the Curve in 1 Dosing Interval (AUC[TAU]) of Oral Ixabepilone With and Without Famotidine in Crossover Cohorts |
218.36; 276.30 | — |
| SECONDARY Number of Participants With Significant Findings on Physical Examination or Electrocardiogram (ECG) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Abnormal (CTC Grade 3 or Greater) Serum Chemistry Levels |
4; 1; 3; 1; 1; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT00422097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.