Trial Information

A Continuation Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004

This is a multicenter, open-label trial of DN-101 and docetaxel combination therapy to
monitor the safety of ongoing DN-101 and docetaxel treatment for subjects previously
enrolled in DN101-002 or DN101-004 studies. For subjects enrolled in DN101-002 study, only
subjects randomized to the DN-101 treatment arm and are currently receiving study drug
(including subjects on study suspension / holiday) will be included in the current study.
For subjects enrolled in DN101-004 study, only subjects who are receiving study treatment
will be included.

Safety will be assessed throughout the study. Safety evaluations will consist of a modified
physical exam (vital signs and weight) and laboratory assessments. Modified physical exam
should be performed at the beginning of each treatment cycle. Docetaxel-related laboratory
assessments will be performed per standard of care as noted in the labeling. DN-101-related
laboratory assessments for serum calcium and serum creatinine will be performed at the
beginning of each treatment cycle. Clinically significant abnormal laboratory values will
be reported as adverse events.