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

Novacea

Status and phase: Unknown; Phase 2

Conditions: Androgen Independent Prostate Cancer (AIPC); Non Small Cell Lung Cancer (NSCLC)

Treatments: Drug: DN-101 (calcitriol) - Drug

Study type: Interventional

Funder types: Industry

Identifiers

NCT00285675

011-016

Details and patient eligibility

About

The purpose of this study is to monitor the safety of continued DN-101 and docetaxel treatment for subjects previously enrolled in DN101-002 (ASCENT) or DN101-004 (NSCLC) Studies.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prior participation in DN101-002 or DN101-004 studies, where the subject received at least one dose of DN-101
• Able and willing to give written informed consent

Exclusion criteria

• Disease progression or unacceptable toxicity while previously enrolled in DN101-002 or DN101-004 studies
• Prior investigational therapy other than DN-101 within 30 days of enrollment
• Known hypersensitivity to calcitriol
• Pregnancy (women of childbearing potential only)
• Greater than 90 days has elapsed from termination of DN101-002 or DN101-004 studies

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)