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

NCT ID: NCT00285675

Last Updated: 2006-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-01-31

Brief Summary

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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

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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.

Conditions

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

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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DN-101 (calcitriol) - Drug

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novacea

INDUSTRY

Sponsor Role lead

Locations

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Alta Bates Comprehensive Cancer Center

Berkeley, California, United States

Site Status

Pacific Hematology Oncology Associates

San Francisco, California, United States

Site Status

Kaiser Permanente Medical Group, Northern California

Vallejo, California, United States

Site Status

Columbia Presbyterian Medical Center

New York, New York, United States

Site Status

Piedmont Hematology Oncology Associates

Winston-Salem, North Carolina, United States

Site Status

NW Kaiser Permanente Portland

Portland, Oregon, United States

Site Status

Alta Bates Comprehensive Center

Portland, Oregon, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

University of Pittsburgh,William Copper Ambulatory Care, Pavillion Hellman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

Tyler Cancer Center

Tyler, Texas, United States

Site Status

Northwest Cancer Specialists Vancouver Office

Vancouver, Washington, United States

Site Status

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Site Status

Cross Cancer Institute, Department of Medicine

Edmonton, Alberta, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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011-016

Identifier Type: -

Identifier Source: org_study_id