Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
4 participants
INTERVENTIONAL
2016-01-31
2017-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Abiraterone
Abiraterone acetate 1000 mg once daily and Prednisone 2x5 mg daily (continuously as per prescription label).
abiraterone acetate
Abiraterone acetate 1000 mg once daily and Prednisone 2x5 mg daily (continuously as per prescription label).
Interventions
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abiraterone acetate
Abiraterone acetate 1000 mg once daily and Prednisone 2x5 mg daily (continuously as per prescription label).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Adult patients with histological or cytological diagnosis of adenocarcinoma of the prostate.
3. Men with castration-resistant metastatic decline maintained for at least 3 weeks as per PCWG2 criteria).
4. Confirmed biochemical response to prior abiraterone acetate (≥50% PSA Informed Consent (including consent for biomarker studies including the fresh tumour biopsies)
5. Progressive disease according to PCWG2 criteria during prior therapy with standard dose of abiraterone acetate (confirmed increase of PSA ≥25% over nadir) or soft-tissue or bone progression. Patients that have stopped abiraterone acetate for reasons other than progression are not eligible.
6. Documented progression of disease by any of the criteria listed here:
* PSA
* Soft tissue
* Bone scan all as per PCWG2 criteria
7. Patients may have received treatment with docetaxel, enzalutamide or radium-223
8. PSA of ≥10ug/l
9. ECOG performance status 0 - 2
10. At least 3 months (90 days) since stop of prior abiraterone acetate.
Exclusion Criteria
2. Prior treatment with cabazitaxel or the CYP-17 inhibitor TAK-700/orteronel
3. Any concurrent treatment or prior treatment with an investigational drug within 28 days prior to start of treatment.
4. Known brain or leptomeningeal disease
5. Concurrent use of steroids other than prednisone \>10mg/d
6. Inadequate bone marrow and organ function as evidenced by:
Platelet count \<75 x 10 G/L ASAT and/or ALAT ≥ 2.5 x ULN Total bilirubin ≥ 1.5 x ULN (≥ 2.0 x ULN for patients with Gilbert's disease) Hypokalaemia despite adequate supplementation Creatinine Clearance \<30ml/min
7. Uncontrolled hypertension or cardiac failure or LVEF \<50%
creatinine clearance is to be calculated by using the formula of Cockcroft-Gault in appendix 4 of the protocol
18 Years
100 Years
MALE
No
Sponsors
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Cantonal Hospital of St. Gallen
OTHER
University Hospital, Basel, Switzerland
OTHER
Aurelius Omlin
OTHER
Responsible Party
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Aurelius Omlin
MD
Principal Investigators
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Aurelius G Omlin, MD
Role: PRINCIPAL_INVESTIGATOR
Cantonal Hospital St. Gallen
Locations
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Cantonal Hospital Chur
Chur, Kanton Graubünden, Switzerland
University Hospital Basel
Basel, , Switzerland
Cantonal Hospital St.Gallen
Sankt Gallen, , Switzerland
Countries
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Other Identifiers
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CTU 14/020
Identifier Type: -
Identifier Source: org_study_id
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