Non-seminomatous Germ-cell TumorsPhase 2CABA-GCTNCT02115165
A Prospective Study of Cabazitaxel in Patients With Non Seminomatous Germ-cell Tumors
A Phase 2 study testing Cabazitaxel in people with Non-seminomatous Germ-cell Tumors, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and older, men only
- Conditions the study is for
- Non-seminomatous Germ-cell Tumors
- What is being tested?
- Cabazitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jul 2014to 24 Apr 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val de Marne, 94805
About this study
Official title: A Prospective Phase II Trial of Cabazitaxel in Male Patients With Chemotherapy Pre-treated Metastatic Nonseminomatous Germ-cell Tumors
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
- Non-seminomatous Germ-cell Tumors
- Being tested
- Cabazitaxel
- Medical subject headings
- Nonseminomatous germ cell tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabazitaxelDrug
On Day 1 of each cycle, patients will receive cabazitaxel at a dose of 25 mg/m², administered by IV route in 1 hour
| Study group | Role | What they receive |
|---|---|---|
| Cabazitaxel | Experimental | Not described Receives: Drug: Cabazitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Favorable response
To evaluate the favorable response rate of cabazitaxel treatment in patients with highly-pretreated nonseminomatous germ-cell tumors (NSGCT)
Measured: Assessed every 6 weeks from start of treatment up to 72 months
Secondary outcomes (3)
Response rate on brain metastases
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
Measured: Assessed every 6 weeks after treatment start up to 72 months
Progression free survival
Measured: Assessed every 6 weeks from treatment start to progression up to 72 months
Overall survival
Measured: Assessed every 3 weeks after treatment start up to 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study start23 Jul 2014
- Primary completion29 Apr 2022
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-seminomatous Germ-cell TumorsStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Karim FIZAZI, MD-PhD, Study chair, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115165
- Sponsor's protocol ID
- 2013-000286-36
- Other IDs
- 2012/1950
- Acronym
- CABA-GCT
- Status last verified
- Mar 2026
- First submitted
- 10 Apr 2014
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Trial of Cabazitaxel in Male Patients With Chemotherapy Pre-treated Metastatic Nonseminomatous Germ-cell Tumors
- ClinicalTrials.gov ID
- NCT02115165
- Acronym / sponsor ID
- CABA-GCT / 2013-000286-36
- Conditions
- Non-seminomatous Germ-cell Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 23 Jul 2014 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cabazitaxel | Experimental | Drug: Cabazitaxel |
Who may qualify
- Ages
- 15 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CabazitaxelOn Day 1 of each cycle, patients will receive cabazitaxel at a dose of 25 mg/m², administered by IV route in 1 hour | Drug | Cabazitaxel |
Primary outcome
Favorable response
Time frame: Assessed every 6 weeks from start of treatment up to 72 months
To evaluate the favorable response rate of cabazitaxel treatment in patients with highly-pretreated nonseminomatous germ-cell tumors (NSGCT)
3 secondary outcomes
Response rate on brain metastases
Time frame: Assessed every 6 weeks after treatment start up to 72 months
Progression free survival
Time frame: Assessed every 6 weeks from treatment start to progression up to 72 months
Overall survival
Time frame: Assessed every 3 weeks after treatment start up to 72 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
Related trials for Non-seminomatous Germ-cell Tumors
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A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karim FIZAZI, MD-PhD study chair
Gustave Roussy, Cancer Campus, Grand Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cabazitaxel in people with Non-seminomatous Germ-cell Tumors, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Favorable response (time frame: Assessed every 6 weeks from start of treatment up to 72 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.