Open Label Extension In Cancer Patients - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00830180

Purpose

To evaluate the safety and efficacy of anti-NGF AB in cancer patients with pain due to bone metastases who participated in the double-blind Study A4091003 and who wish to receive open-label therapy.

Condition	Intervention	Phase
Breast Neoplasms Prostatic Neoplasms	Biological: Anti-NGF AB	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	Phase II Open-Label Safety Extension Study Of Tanezumab In Cancer Patients With Pain Due To Bone Metastases

Further study details as provided by Pfizer:

Primary Outcome Measures:

Clinical laboratory tests [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Electrocardiograms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Brief Pain Inventory [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Karnofsky Performance Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	May 2009
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Anti-NGF AB: Experimental	Biological: Anti-NGF AB Solution for injection, 10 mg, one injection/8 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Prostate or breast cancer that has been diagnosed as having metastasized to bone;
Karnofsky Performance Score ≥40% at Baseline;
patients randomized and treated with intravenous study drug in double-blind Study A4091003.

Exclusion Criteria:

Patient was withdrawn from Study A4091003 for an adverse event or serious adverse event;
Occurrence of any adverse event or condition during Study A4091003 or since termination from that study that, in the opinion of the Investigator, would put the patient at increased safety risk or should exclude the subject from participating in the open-label extension Study A4091029.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830180

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4091029
Study First Received:	January 26, 2009
Last Updated:	April 13, 2009
ClinicalTrials.gov Identifier:	NCT00830180 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Cancer pain, NGF, open-label extension

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Skin Diseases
Neoplasm Metastasis
Breast Neoplasms

Urogenital Neoplasms
Pain
Genital Diseases, Male
Prostatic Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Skin Diseases

Breast Neoplasms
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 06, 2009