Status:
TERMINATED
Carboplatin in Castration-resistant Prostate Cancer
Lead Sponsor:
Aurelius Omlin
Collaborating Sponsors:
Teva Pharma
University Hospital, Zürich
Conditions:
Prostatic Neoplasm
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
Open label, non-randomised phase II clinical pilot study
Detailed Description
Pilot Study of weekly Carboplatin in Patients with Advanced Metastatic Castration-Resistant Prostate Cancer (CRPC) and DNA repair defects
Eligibility Criteria
Inclusion
- Written Informed Consent
- Adult patients with histological diagnosis of adenocarcinoma of the prostate.
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- 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).
- DNA repair defects as per central assessment
- Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0 - 2
- Progression of disease by any of the criteria listed here:
- PSA utilizing PCWG 2 criteria
- Bone scan
- RECIST 1.1
- 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
- Patient must agree in the biomarker studies including the fresh tumour biopsies
Exclusion
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product Carboplatin
- Prior treatment with any prior platinum based chemotherapy,
- Major surgery within 4 weeks prior to planned start of treatment
- Known brain or leptomeningeal involvement unless clinically stable and on stable dose of steroids
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Previous enrolment into the current study
- Active secondary malignancy that requires systemic therapy.
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02311764
Start Date
February 1 2015
End Date
December 1 2019
Last Update
January 23 2020
Active Locations (3)
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1
Cantonal Hospital Chur
Chur, Kanton Graubünden, Switzerland, 7000
2
Luzern Cantonal Hospital
Lucerne, Switzerland
3
Cantonal Hospital St.Gallen
Sankt Gallen, Switzerland, 9007