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

Conditions

• Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - 79 Years

Healthy Volunteers

Not accepted

Interventions

• tasquinimod — DRUG
  tasquinimod 0.25 mg continuously
• tasquinimod 0.25 mg; 0.5 mg — DRUG
  tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg continuously, if tolerated
• tasquinimod 0.25 mg; 0.5 mg; 1.0 mg — DRUG
  tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg for 3 weeks followed by 1.0 mg continuously, if tolerated

Study Details

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).

Key Dates

Start date

Jan 31, 2012

Status verified

Aug 2018

Primary completion

Jun 30, 2015

Completion

Jun 30, 2016

Study Design

Enrollment

25 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Tasquinimod single dose
• Experimental: tasquinimod 0.25 mg followed by 0.5 mg
  tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg continuously, if tolerated
• Experimental: tasquinimod 0.25 mg; 0.5 mg; 1.0 mg
  tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg for 3 weeks followed by 1.0 mg continuously, if tolerated

Primary Outcome Measure

Number of participants who experience dose limiting toxicities at the highest titrated dose for each dose level [ Time Frame: 6 weeks ]

Locations (2)

Find similar trials in Chicago, IL

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