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tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg continuously, if tolerated

tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg for 3 weeks followed by 1.0 mg continuously, if tolerated

tasquinimod

tasquinimod 0.25 mg; 0.5 mg

tasquinimod 0.25 mg; 0.5 mg; 1.0 mg

Andrew Armstrong, MD

The standard of care for men with metastatic CRPC in 2010 following progression on docetaxel is cabazitaxel or abiraterone acetate/prednisone. Based on results from two other studies, cabazitaxel and prednisone has become a standard second line chemotherapy regimen and becomes the backbone upon which to improve upon. Thus, the primary objective of this study is to determine the recommended dose of tasquinimod in combination with cabazitaxel and prednisone based on safety and tolerability in men with chemorefractory metastatic castration-resistant prostate cancer (CRPC).

The CATCH Prostate Cancer Trial: Cabazitaxel And Tasquinimod in Men With Prostate Cancer

The CATCH Prostate Cancer Trial: Cabazitaxel And Tasquinimod in Men With Castration-Resistant Heavily Pre-treated Prostate Cancer

The primary objective is to determine the recommended dose of tasquinimod in combination with cabazitaxel and prednisone based on safety and tolerability in men with chemorefractory metastatic castration-resistant prostate cancer (CRPC).

Preliminary evidence of durable efficacy will be based on a modified PCWG2-defined radiologic progression-free survival including RECIST 1.1 criteria (PFS).

Radiologic response criteria using RECIST 1.1 (overall response)

Detailed characterization of all NCI CTC v4.0 toxicities over time (per cycle)

Pharmacokinetic analysis of tasquinimod and cabazitaxel (cycle 1-4 only)

Descriptive statistics will be used to summarize laboratory variables

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The CATCH Prostate Cancer Trial: Cabazitaxel And Tasquinimod in Men With Prostate Cancer	NCT01513733	Prostate Cancer	tasquinimod tasquinimod 0.2... tasquinimod 0.2...	18 Years - 79 Years	Duke University
The CATCH Prostate Cancer Trial: Cabazitaxel And Tasquinimod in Men With Prostate Cancer	NCT01513733	Prostate Cancer	tasquinimod tasquinimod 0.2... tasquinimod 0.2...	18 Years - 79 Years	Duke University

Spots Global Cancer Trial Database for tasquinimod 0.25 mg; 0.5 mg