Cabazitaxel in metastatic prostate cancer patients with AR-V7 positive CTCs

Phase 1

• Conditions: metastatic castration-resistant prostate cancer; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2016-002993-11-NL
• Lead Sponsor: Erasmus MC Cancer Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-08
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Histologically or cytologically confirmed adenocarcinoma of the prostate
without neuroendocrine differentiation or small cell features.
- Continued androgen deprivation therapy either by LHRH
agonists/antagonists or orchiectomy.
- Serum testosterone <50 ng/ml (1.7 nmol/L) within 21 days of
treatment arm allocation.
- Age =18 years
progression for study entry is defined as one or more of the following
criteria:
• At least 3 consecutive PSA rises over a reference value, with an
interval of = 1 week between each determination. PSA at screening visit
should be = 2.0 µg/l.
• Bone disease progression defined by the appearance of =2 new
lesions on a bone scan (confirmed by a second bone scan 6 weeks later).
• Soft tissue disease progression defined by modified RECIST 1.1.
- ECOG performance status 0-2
- Written informed consent according to ICH-GCP
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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

• Geographical, psychological or other non-medical conditions
interfering with follow-up
• Uncontrolled severe illness or medical condition (including
uncontrolled diabetes mellitus or active systemic or local bacterial, viral,
fungal - or yeast infection)
• Symptomatic CNS metastases or history of psychiatric disorder that
would prohibit the understanding and giving of informed consent.
• Chemotherapy or immunotherapy (other than LHRH analogues)
within the last 4 weeks before study inclusion.
• Prior treatment with cabazitaxel
• Successive treatment with both abiraterone and enzalutamide in the
post-docetaxel setting
• Radiotherapy to 40% or more of the bone marrow
• Known hypersensitivity to corticosteroids
• 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 (a one week wash-out period is
necessary for patients who are already on these treatments) (see
Appendix C)
• Concomitant vaccination with yellow fever vaccine
• Abnormal liver functions consisting of any of the following (within 21
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days before treatment group allocation):
• Total bilirubin > 1.5 x ULN (except for patients with documented
Gilbert's disease)
• If total bilirubin > 1 x ULN or AST > 1.5 x ULN inclusion is permitted
but cabazitaxel dose should be reduced 20mg/m2
• Abnormal hematological blood counts consisting of any of the
following (within 21 days before treatment group allocation):
• Absolute neutrophil count < 1.5 x 109/L
• Platelets < 100 x 109/L
• Hemoglobin < 6.2 mmol/L

Study & Design

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