Clinical trial · Interventional
A Prospective Study of Cabazitaxel in Patients With Non Seminomatous Germ-cell Tumors
A Prospective Phase II Trial of Cabazitaxel in Male Patients With Chemotherapy Pre-treated Metastatic Nonseminomatous Germ-cell Tumors
NCT02115165CI-TRIAL-00107414CABA-GCTcompletedPhase 2ClinicalTrials.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)
Cabazitaxel is a new generation taxane with a high capacity for blood-brain barrier crossing and limited peripheral neuro-toxicity, two major potential advantages in patients with advanced NSGCTs. Cabazitaxel has a broader in vitro spectrum of activity than docetaxel. Taxanes have demonstrated activity in pre-treated GCTs and are now part of standard treatment, but cabazitaxel has not yet been tested in patients with NSGCT.
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 |
|---|---|---|---|
| Non-seminomatous Germ-cell Tumors | Non-Seminomatous Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cabazitaxel | Drug | Cabazitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cabazitaxel
- interventionNames
- Drug: Cabazitaxel
Primary outcomes (1)
- measure
- Favorable response
- timeFrame
- Assessed every 6 weeks from start of treatment up to 72 months
- description
- To evaluate the favorable response rate of cabazitaxel treatment in patients with highly-pretreated nonseminomatous germ-cell tumors (NSGCT)
Secondary outcomes (3)
- measure
- Response rate on brain metastases
- timeFrame
- Assessed every 6 weeks after treatment start up to 72 months
- description
- MRI of the brain every 6 weeks only in case of brain metastases detected at baseline and for all patients at the end of the study. Evaluation will be made using RECIST V1.1
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * Male patients aged 15 years or older * Evidence of advanced NSGCT documented either by pathology or by elevated tumor markers (AFP or hCG) and a compatible clinical presentation * Primary site located in either the testis, the retroperitoneum or the mediastinum * Progressive disease after at least 2 lines of chemotherapy for advanced NSGCT (ie, non-stage I) * In case of brain metastases, confirm that patients should be stable / controlled with corticosteroid/anti seizures agents * No other progressive carcinoma within previous the 5 years, except for basal-cell carcinoma of the skin * Life expectancy \>/= 3 months * Adequate hematologic function : * Hemoglobin \>/= 10.0 g/dL * Absolute neutrophil count \>/= 1.5 x 10 \^ 9/L, * Platelet count \>/= 100 x 10 \^ 9/L, * Adequate organ function * Serum creatinine \< 1.5 x ULN. If serum creatinine 1.0 - 1.5 x ULN, creatinine clearance calculated (or measured) according to CKD-EPI formula (see Appendix B) \> 60 mL/min * AST/SGOT and ALT/SGPT \</= 1.5 x ULN * Bilirubin \</= 1.5 x ULN * Information delivered to patient and informed consent form signed by the patient or his legal representative * Patient affiliated to a social security system or beneficiary of the same Exclusion Criteria: * Patients receiving anti cancer therapy within 4 weeks prior to enrolment * Previous radiotherapy within 4 weeks prior to enrolment * Serious uncontrolled concurrent medical illness * History of severe hypersensitivity reaction (\>/= grade 3) to polysorbate 80 containing drugs or to other taxanes * Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (see Appendix A). A one week wash-out period is necessary for patients who are already on these treatments. * Patient with reproductive potential not implementing accepted and effective method of contraception for up to 6 months after the last dose of cabazitaxel. * Active Grade \>/= 3 peripheral neuropathy * Patients who have had a major surgery within 4 last weeks prior enrolment * Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension. History of congestive heart failure (NYHA III or IV) or myocardial infarction within last 6 months is also not allowed
References
Publications (0)
Data not yet available
No reference posted for this study.