NCT01595087 - A Phase I/II Study of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

June 30, 2013

Study Completion Date

September 30, 2013

Conditions

Prostate Cancer Metastatic

Interventions

DRUG

Osteodex

Seven cohorts; Dose cohort 1; 0.1 mg/kg given every third week, maximum 7 times. Dose cohort 2; 0.3 mg/kg given every third week, maximum 7 times. Dose cohort 3; 0.6 mg/kg given every third week, maximum 7 times. Dose cohort 4; 0.9 mg/kg given every third week, maximum 7 times. Dose cohort 5; 1.2 mg/kg given every third week, maximum 7 times. Dose cohort 6; 1.5 mg/kg given every third week, maximum 7 times. Dose cohort 7; 3.0 mg/kg given every third week, maximum 7 times.

Trial Locations (3)

221 85

Oncology clinic, Skånes Universitetssjukhus i Lund, Lund

118 83

Urology clinic, Södersjukhuset AB, Stockholm

901 85

Oncology clinic, Norrlands Universitetssjukhus, Umeå