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Objectives: This randomized, open-label phase III non-inferiority trial compares 20 mg/m2 and 25 mg/m2 doses of cabazitaxel (Jevtana). It seeks to determine whether the lower dose may be better tolerated without reducing the benefit in overall and progression-free survival.
Key entry or exclusion criteria: Patients must be resistant to hormone therapy and previously treated with docetaxel (Taxotere). Men previously treated with cabazitaxel or mitoxantrone (Novantrone) are excluded.
Locations: 172 sites.
Goal: 1,200 patients.
Study sponsor: Sanofi-Aventis
Link for more information: clinicaltrials.gov/ct2/show/NCT01308580
NIH clinical trials identifier: NCT01308580
Objectives: This randomized, open-label phase III non-inferiority trial compares 20 mg/m2 and 25 mg/m2 doses of cabazitaxel (Jevtana). It seeks to determine whether the lower dose may be better tolerated without reducing the benefit in overall and progression-free survival.
Key entry or exclusion criteria: Patients must be resistant to hormone therapy and previously treated with docetaxel (Taxotere). Men previously treated with cabazitaxel or mitoxantrone (Novantrone) are excluded.
Locations: 172 sites.
Goal: 1,200 patients.
Study sponsor: Sanofi-Aventis
Link for more information: clinicaltrials.gov/ct2/show/NCT01308580
NIH clinical trials identifier: NCT01308580
Objectives: This randomized, open-label phase III non-inferiority trial compares 20 mg/m2 and 25 mg/m2 doses of cabazitaxel (Jevtana). It seeks to determine whether the lower dose may be better tolerated without reducing the benefit in overall and progression-free survival.
Key entry or exclusion criteria: Patients must be resistant to hormone therapy and previously treated with docetaxel (Taxotere). Men previously treated with cabazitaxel or mitoxantrone (Novantrone) are excluded.
Locations: 172 sites.
Goal: 1,200 patients.
Study sponsor: Sanofi-Aventis
Link for more information: clinicaltrials.gov/ct2/show/NCT01308580
NIH clinical trials identifier: NCT01308580