Lung Cancer Clinical Trial

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

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.

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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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

25

Study ID:

NCT00285675

Recruitment Status:

Unknown status

Sponsor:

Novacea

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There are 12 Locations for this study

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Alta Bates Comprehensive Cancer Center
Berkeley California, 94704, United States
Pacific Hematology Oncology Associates
San Francisco California, 94115, United States
Kaiser Permanente Medical Group, Northern California
Vallejo California, 94589, United States
Columbia Presbyterian Medical Center
New York New York, 10032, United States
Piedmont Hematology Oncology Associates
Winston-Salem North Carolina, 27103, United States
NW Kaiser Permanente Portland
Portland Oregon, 97227, United States
Alta Bates Comprehensive Center
Portland Oregon, 97239, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
University of Pittsburgh,William Copper Ambulatory Care, Pavillion Hellman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
Tyler Cancer Center
Tyler Texas, 75702, United States
Northwest Cancer Specialists Vancouver Office
Vancouver Washington, 98684, United States
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute, Department of Medicine
Edmonton Alberta, T6G 1, Canada

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

25

Study ID:

NCT00285675

Recruitment Status:

Unknown status

Sponsor:


Novacea

How clear is this clinincal trial information?

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