Clinical trial · Interventional
Effect of Cabazitaxel on the QTc Interval in Cancer Patients
QT-Cab: An Open-Label Study to Investigate the Effect of Cabazitaxel on the QTc Interval in Cancer Patients
- 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)
Primary Objective: * To assess the potential effect on QTcF interval (QTc Fridericia) of cabazitaxel in cancer patients Secondary Objectives: * To assess the effects of cabazitaxel on heart rate (HR), QT, QTcB (Bazett's correction), and QTcN (population specific correction) intervals * To assess the clinical safety of cabazitaxel * To assess cabazitaxel plasma concentrations at Cycle 1 at early timepoints (during infusion and up to 5h post end of infusion)
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 |
|---|---|---|---|
| Neoplasms, Malignant | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cabazitaxel (XRP6258) | Drug | Cabazitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- cabazitaxel
- description
- At every cycle (every 3 weeks), on Day 1, patients will receive cabazitaxel, administered by intravenous (IV) infusion over 1 hour, at 25 mg/m2. An IV premedication regimen composed of up to 4 treatments (antihistamine, corticosteroids, H2 antagonist other than cimetidine at all cycles, plus palonosetron at cycle 1) will be administered before cabazitaxel infusion.
- interventionNames
- Drug: Cabazitaxel (XRP6258)
Primary outcomes (1)
- measure
- Change from baseline in QT interval corrected calculation by Fridericia method
- timeFrame
- Cycle 1, Day 1
Secondary outcomes (4)
- measure
- Change from baseline in Heart rate, QT, QTcB (QT interval corrected calculation by Bazett method) and QTcN (QT interval with a population-specific correction formulae) intervals
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Histologically or cytologically confirmed solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist, and a treatment with a novel taxane agent is considered. Exclusion criteria: * Conditions with screening ECG repolarization difficult to interpret, or showing significant abnormalities. This includes, but is not limited to: high degree AV block, pace-maker, atrial fibrillation or flutter * QTcF \>480 msec on screening Electrocardiogram (ECG) * Significant hypokalemia at screening (serum potassium \<3.5 mMol/L) * Significant hypomagnesemia at screening (serum magnesium \<0.7 mMol/L) (Note: Patient may be enrolled after correction of these laboratory abnormalities) * Patient receives (and cannot discontinue), or is scheduled to receive a QT-prolonging drug The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (0)
Data not yet available