Description:
Open label, non-randomised phase II clinical pilot study
Title
- Brief Title: Carboplatin in Castration-resistant Prostate Cancer
- Official Title: Single Arm Open Label Phase II Pilot Study of Carboplatin in Patients With Metastatic Castrationresistant Prostate Cancer (CRPC) and PTEN Loss and/or DNA Repair Defects
Clinical Trial IDs
- ORG STUDY ID:
CTU-14005
- NCT ID:
NCT02311764
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Carboplatin | | Carboplatin |
Purpose
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
Trial Arms
Name | Type | Description | Interventions |
---|
Carboplatin | Experimental | Carboplatin will be administered weekly | |
Eligibility Criteria
Inclusion Criteria:
1. Written Informed Consent
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:
1. Contraindications to the class of drugs under study, e.g. known hypersensitivity or
allergy to class of drugs or the investigational product Carboplatin
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Response |
Time Frame: | Time Frame: Up to the end of the treatment phase (ie, approximately 6 months |
Safety Issue: | |
Description: | Soft tissue or PSA Response |
Secondary Outcome Measures
Measure: | Rate of PSA declines of ≥30% |
Time Frame: | Time Frame: At 12 weeks and up to the end of the treatment phase (ie, approximately 6 months) |
Safety Issue: | |
Description: | PSA |
Measure: | OS |
Time Frame: | Time Frame: livelong follow-up |
Safety Issue: | |
Description: | Overall survival (OS) form start of Carboplatin |
Measure: | rPFS |
Time Frame: | Time Frame: Up to the end of the treatment phase (ie, approximately 6 months |
Safety Issue: | |
Description: | Radiological progression-free survival (rPFS) from start of carboplatin |
Measure: | PSA |
Time Frame: | on studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months |
Safety Issue: | |
Description: | Time to PSA progression |
Measure: | Safety as per CTC AEv4.03 |
Time Frame: | on studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months |
Safety Issue: | |
Description: | Number of patients with adverse events |
Measure: | Disease control rate |
Time Frame: | On studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months |
Safety Issue: | |
Description: | Disease control rate at 12 and 24 weeks (defined as SD, PR, CR, see response criteria |
Measure: | PTEN loss |
Time Frame: | Pre-study biopsy sample |
Safety Issue: | |
Description: | Evaluation of PTEN loss by FISH (Frequency and correlation with IHC) |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | Aurelius Omlin |
Last Updated
January 23, 2020