Clinical trial · Interventional
Phase 1 Trial of Oral Ixabepilone
A Phase 1 Study of Ixabepilone Administered as 3 Oral Doses Each Separated by 6 Hours Every 21 Days in Subjects With Advanced Cancer
NCT00632424CI-TRIAL-00021285terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business Objectives Changed
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ixabepilone (oral formulation) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Ixabepilone (oral formulation)
Primary outcomes (2)
- measure
- Number of Participants With a Dose-Limiting Toxicity (DLT)
- timeFrame
- During Cycle 1 (Day 0 through Day 21)
- description
- 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.
- measure
- Ixabepilone Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.