Clinical trial · Interventional
The Effect of Tesetaxel on the QTc Interval and the Effect of Food, Itraconazole, and Rifampin on Tesetaxel Pharmacokinetics in Patients With Advanced Solid Tumors
An Open-Label Study of the Effect of Tesetaxel on the QTc Interval and the Effect of Food, Itraconazole, and Rifampin on Tesetaxel Pharmacokinetics in Patients With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The Sponsor has discontinued the development of tesetaxel
Summary
Brief summary (as posted)
This is a 3-cohort, multicenter, Phase 1 study of the effect of tesetaxel, an investigational, orally administered taxane, on the corrected QT (QTc) interval and the potential effect of food, a cytochrome P450 (CYP) 3A inhibitor (itraconazole), and a CYP3A inducer (rifampin) on tesetaxel pharmacokinetics (PK) in adult patients with advanced solid tumors.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Itraconazole | Drug | — | UNRESOLVED |
| Rifampin | Drug | — | UNRESOLVED |
| Tesetaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort 1, Sequence 1A: Fed then fasted
- description
- Cycle 1: Tesetaxel on Day 1 of a 21-day cycle under fed conditions Cycle 2: Tesetaxel on Day 1 of a 21-day cycle under fasted conditions
- interventionNames
- Drug: Tesetaxel
- type
- EXPERIMENTAL
- label
- Cohort 1, Sequence 1B: Fasted then fed
- description
- Cycle 1: Tesetaxel on Day 1 of a 21-day cycle under fasted conditions Cycle 2: Tesetaxel on Day 1 of a 21-day cycle under fed conditions
- interventionNames
- Drug: Tesetaxel
- type
- EXPERIMENTAL
- label
- Cohort 2: Tesetaxel plus itraconazole
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female or male patients at least 18 years of age * Histologically or cytologically confirmed solid tumor * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 * Adequate cardiac conduction by ECG * Adequate bone marrow, hepatic, and renal function Exclusion Criteria: * Presence of risk factors for QTc prolongation * Presence of neuropathy Grade \> 1 * Anticancer treatment ≤ 14 days prior to randomization * Major surgery ≤ 28 days prior to randomization * Less than 2 weeks or 5 plasma half-lives (whichever is greater) since last use of: * A moderate or strong inhibitor or inducer of CYP3A * A CYP3A substrate with a narrow therapeutic range or that is contraindicated with either itraconazole or rifampin
References
Publications (0)
Data not yet available