Cisplatin-resistant germ cell cancer MedDRA version: 17.0 Level: LLT Classification code 10043321 Term: Testicular germ cell cancer NOS System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Jevtana
Product Name: Jevtana
Product Code: XRP6258
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: Cabazitaxel
CAS Number: 183133-96-2
Current
Sponsors
Oslo University Hospital
Oslo University Hospital, Cancer Research Un it
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: · Male patients = 18 years old · Histologically verified metastatic GCC (germ cell cancer of the testicle or extragonadal GCC originating from retroperitoneum or mediastinum) · Disease progression during cisplatin-based chemotherapy or Disease progression or relapse after high-dose chemotherapy or Disease progression or relapse after at least 2 different platin-based · ECOG Performance Status (PS): 0-2 · Life expectancy =3 months · Adequate function of liver, kidneys and bone marrow at baseline · Signed written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: · Systemic antitumor treatment within 21 days before study entry · Simultaneous radiotherapy to the only target lesion · Patients unwilling or unable to comply with the protocol · Patients with unstable angina pectoris, myocardial infarction = 6 months prior to first study treatment, congestive heart failure NYHA III-IV or serious uncontrolled cardiac arrhythmias · Patients with an active or uncontrolled infection · Patients who have a history of another primary malignancy and are off treatment for = 3 years, with the exception of non-melanoma skin cancer · Patients who have undergone major surgery within 4 weeks prior to starting study drug (e.g. intra-thoracic, intra-abdominal, or intra-pelvic) or significant traumatic injury, or who have not recovered from the side effects of any of the above within 6 weeks · Patients who have participated in another interventional clinical trial within 30 days before study entry · Other serious medical conditions that could impair the ability of the patient to participate in the study · Active infection requiring systemic antibiotic-, anti-viral-, or antifungal medication · Neuropathy = Grade 2 · Patient with reproductive potential not implementing accepted and effective method of contraception during the whole study period and up to 6 months after the last dose of cabazitaxel. · One or more of the following cabazitaxel-specific requirements: - History of severe hypersensitivity reaction (= Grade 3) to docetaxel - History of severe hypersensitivity reaction (= Grade 3) to polysorbate 80 containing drugs - Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 - Concurrent or planned treatment with OATP1B1 substrates within 12 hours before- or 3 hours after application of cabazitaxel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of cabazitaxel as monotherapy for the treatment of germ cell cancer. Efficacy is defined objective responses according to RECIST 1.1;Secondary Objective: Disease control rate (SD + PR + CR) Progression-free survival Overall survival Safety profile Change of serum tumor markers;Primary end point(s): Objective response rate (ORR) by radiologic response according to RECIST 1.1 ;Timepoint(s) of evaluation of this end point: Tumor measurements by a CT scan or MRI will be performed at screening within 2 weeks prior to the first dose of study drug. During the study period, the CT scan/MRI will be performed every 9 weeks (± one week), and at the time of discontinuation of study drug (within 2 weeks). The same type of scan (CT or MRI) used at screening must be used for all subsequent follow-up assessments. A partial or a complete response warrants a confirmation no sooner than 4 weeks after its observation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): · Safety profile /Adverse events (AE) · Disease control rate (SD + PR + CR) · Progression-free survival (PFS) -time from inclusion to the date of disease progression · Overall survival (OS) - time from inclusion to the date of death from any cause · Change of serum tumormarkers (AFP, beta-betaHCG, LDH) ;Timepoint(s) of evaluation of this end point: Tumor measurements by a CT scan or MRI will be performed at screening within 2 weeks prior to the first dose of study drug. During the study period, the CT scan/MRI will be performed every 9 weeks (± one week), and at the time of discontinuation of study drug (within 2 weeks). The same type of scan (CT or MRI) used at screening must be used for all subsequent follow-up assessments. A partial or a complete response warrants a confirmation no sooner than 4 weeks after its observation. Tumor markers (AFP, betaHCG) will be assessed every 3 weeks. | — |
Countries
Denmark, Italy, Norway, Sweden
Contacts
Public ContactJan Oldenburg
Oslo University Hospital
Outcome results
None listed