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
16 participants
INTERVENTIONAL
2015-02-28
2019-12-31
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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Carboplatin
Carboplatin will be administered weekly
Carboplatin
Carboplatin will be administered weekly
Interventions
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Carboplatin
Carboplatin will be administered weekly
Eligibility Criteria
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Inclusion Criteria
2. Adult patients with histological diagnosis of adenocarcinoma of the prostate.
3. Metastatic Castration-Resistant Prostate Cancer (mCRPC)
4. Progression after at least one taxane-based chemotherapy (or contraindication against taxanes) and at least one therapy with a newer hormonal agent (Cyp17 inhibitor or a new generation AA like enzalutamide).
5. DNA repair defects as per central assessment
6. Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0 - 2
7. Progression of disease by any of the criteria listed here:
* PSA utilizing PCWG 2 criteria
* Bone scan
* RECIST 1.1
8. Adequate organ and bone marrow function as evidenced by:
* Haemoglobin ≥8.0 g/dL
* Absolute neutrophil count ≥1.5 x 109/L
* Platelet count ≥ 100 x 109/L
* AST and/or ALT \< 2.5 x ULN, in the presence of liver metastases: AST ≥5 x ULN, ALT \<5 x ULN
* Total bilirubin \< 2.0 x ULN (except for patients with Gilbert's disease)
* Creatinine Clearance ≥30ml/min
9. Patient must agree in the biomarker studies including the fresh tumour biopsies
Exclusion Criteria
2. Prior treatment with any prior platinum based chemotherapy,
3. Major surgery within 4 weeks prior to planned start of treatment
4. Known brain or leptomeningeal involvement unless clinically stable and on stable dose of steroids
5. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
6. Previous enrolment into the current study
7. Active secondary malignancy that requires systemic therapy.
18 Years
MALE
No
Sponsors
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Teva Pharma
INDUSTRY
University Hospital, Zürich
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
Luzern Cantonal Hospital
Lucerne, , Switzerland
Cantonal Hospital St.Gallen
Sankt Gallen, , Switzerland
Countries
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Other Identifiers
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CTU-14005
Identifier Type: -
Identifier Source: org_study_id
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