Cabazitaxel mot cisplatin resistent testikkelkreft

Phase 1

• Conditions: Cisplatin-resistant germ cell cancer; MedDRA version: 17.0Level: LLTClassification code 10043321Term: Testicular germ cell cancer NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-004418-32-DK
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-31
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 29

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

· 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified