Castration Resistant Prostate Cancer Clinical Trial
Official title:
Phase 1 Study to Evaluate Safety, and Preliminary Efficacy of Pasireotide LAR in Castration Resistant Prostate Cancer
After failure of initial ADT, addition of an anti-androgen is established to treat castration resistant prostate cancer (CRPC). Substitution of the first anti-androgen and anti-androgen withdrawal results in treatment responses in 25-40% of patients for 4-6 months. A more effective second line treatment after failure of first ADT could prolong the time until the state of symptomatic HRPC, which is currently treated with docetaxel and accompanied by significant side effects. Since the importance of the IGF-signaling in PC is not only indicated by preclinical results but also by clinical efficacy of somatostatin analogs, further clinical research with the new somatostatin analog pasireotide is warranted. This study is designed to define the maximum tolerated dose (MTD) of pasireotide LAR in patients with castration resistant prostate cancer (CRPC). It also aims for a preliminary efficacy evaluation of pasireotide within the dose expansion part at the MTD. Preliminary efficacy will be assessed by evaluation of different measures of prostate cancer e.g. changes in PSA, disease control rate (RECIST 1.1), symptoms and changes of biomarkers linked to the mode of action of pasireotide LAR. The study will also explore characteristics of patients who might benefit most from this treatment approach
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01120470 -
OGX-427 in Castration Resistant Prostate Cancer Patients
|
Phase 2 | |
Completed |
NCT02384382 -
A Positron Emission Tomography/Computed Tomography (PET/CT) Bone Imaging Study in Patients Receiving Enzalutamide for Castration-Resistant Prostate Cancer (CRPC)
|
Phase 2 | |
Recruiting |
NCT02502994 -
Phase 1 Study of GEN0101 in Patients With Recurrence of CRPC
|
Phase 1 | |
Not yet recruiting |
NCT05919329 -
Evaluation of the Change in PSMA Expression in Prostate Cancer in Response to Hormonal Therapy
|
Phase 4 | |
Terminated |
NCT01522443 -
Study of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer
|
Phase 3 | |
Completed |
NCT01637402 -
A Phase II Study of Increased-Dose Abiraterone Acetate in Patients With Castration Resistant Prostate Cancer
|
Phase 2 | |
Completed |
NCT02833883 -
Use of an Experimental Drug, CC-115, With Enzalutamide in Men With Castration-Resistant Prostate Cancer
|
Phase 1 | |
Completed |
NCT01605227 -
Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100
|
Phase 3 | |
Completed |
NCT04580485 -
INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors
|
Phase 1 | |
Terminated |
NCT01995058 -
Study of Cabozantinib in Combination With Abiraterone in Chemotherapy-Naïve Subjects With Bone-Metastatic Castration-Resistant Prostate Cancer
|
Phase 2 | |
Completed |
NCT01540071 -
Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer
|
Phase 2 | |
Completed |
NCT03473925 -
Efficacy and Safety Study of Navarixin (MK-7123) in Combination With Pembrolizumab (MK-3475) in Adults With Selected Advanced/Metastatic Solid Tumors (MK-7123-034)
|
Phase 2 | |
Withdrawn |
NCT05445882 -
N-803 Alone or in Combination With BN-Brachyury Vaccine or Bintrafusp Alfa (M7824) for Participants With Castration Resistant Prostate Cancer
|
Phase 2 |