Clinical trial · Interventional
Study of Tesetaxel in Japanese Patients With Solid Tumors
A Phase I Study of Tesetaxel Administered Once Every 21 Days to Japanese Subjects With Advanced Solid Tumors
NCT01337310CI-TRIAL-00006459unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Tesetaxel is an orally active tubulin-binding inhibitor of the taxane class. Evaluation of tesetaxel in Japanese patients has been limited. This study is being conducted to determine the maximum tolerated dose and safety of tesetaxel administered orally once every 21 days to Japanese patients.
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 |
|---|---|---|---|
| Tesetaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tesetaxel
- description
- Tesetaxel administered orally once every 21 days for at least 2 cycles
- interventionNames
- Drug: Tesetaxel
Primary outcomes (1)
- measure
- Maximum tolerated dose in mg/m2 based on the dose-limiting adverse events that occur
- timeFrame
- First cycle (expected to be 21 days, including the day of first dose of tesetaxel followed by a rest period)
Secondary outcomes (3)
- measure
- Dose-limiting toxicities (adverse events that result in a reduction in the dose of tesetaxel in the dose-escalation scheme)
- timeFrame
- First cycle (expected to be 21 days, including the day of first dose of tesetaxel followed by a rest period)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Primary inclusion criteria: * At least 20 years of age * Morphologic or cytologic confirmation of an advanced or metastatic solid tumor malignancy, not to include lymphoma, for which no standard therapy exists or for which resistance or intolerance to standard therapy has developed * ECOG performance status not more than 1 * Adequate bone marrow, hepatic, and renal function * Willing to remain hospitalized for at least 10 days following tesetaxel administration in Cycle 1 * At least 4 weeks and recovery from effects of prior surgery or other therapy with an approved or investigational agent, with resolution of any toxicity to not more than Grade 1 Primary exclusion criteria: * Brain metastasis or leptomeningeal disease * Significant medical disease other than cancer * Neuropathy greater than Grade 1
References
Publications (0)
Data not yet available
No reference posted for this study.