New chemo drug shows promise for tough testicular cancers
NCT ID NCT02115165
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tested a chemotherapy drug called cabazitaxel in 34 men with advanced testicular cancer that had already been treated with at least two other chemotherapies. The goal was to see if cabazitaxel could shrink tumors, including those that spread to the brain. Cabazitaxel is a newer type of taxane drug that may work better and cause fewer nerve problems than older options.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cabazitaxel
- What this could lead to
- If it works, this could offer a new treatment option for men with advanced testicular cancer that has stopped responding to standard chemotherapy.
- What could go wrong
- This is a small, early-phase trial with only 34 participants. It may not show enough benefit to become a standard treatment, and cabazitaxel can cause side effects like low blood counts and fatigue.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
34 people
The number who actually took part.
- Started
-
Jul 2014
- Finished
-
Apr 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
15 years and older
- Sex
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Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val de Marne, 94805, France
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