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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00285675

Enrollment

Registered

2006-02-02

Start date

2006-04-30

Completion date

2008-01-31

Last updated

2006-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgen Independent Prostate Cancer (AIPC), Non Small Cell Lung Cancer (NSCLC)

Keywords

Calcitriol, DN-101, Androgen Independent Prostate Cancer (AIPC), Prostate Cancer, Non Small Cell Lung Cancer (NSCLC)

Brief summary

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.

Detailed 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.

Interventions

DRUGDN-101 (calcitriol) - Drug

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026