ClinicalTrials.gov
ClinicalTrials.gov Menu

Open Label Extension In Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00830180
Recruitment Status : Completed
First Posted : January 27, 2009
Last Update Posted : March 31, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Neoplasms Bone Metastases Biological: Anti-NGF AB Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Open-Label Safety Extension Study Of Tanezumab In Cancer Patients With Pain Due To Bone Metastases
Study Start Date : October 2009
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Arm Intervention/treatment
Experimental: Anti-NGF AB Biological: Anti-NGF AB
Solution for injection, 10 mg, one injection/8 weeks



Primary Outcome Measures :
  1. Clinical laboratory tests [ Time Frame: 9 months ]
  2. Electrocardiograms [ Time Frame: 9 months ]
  3. Adverse events [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Brief Pain Inventory [ Time Frame: 9 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prostate cancer, breast cancer, renal cell carcinoma or multiple myeloma 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830180


Locations
United States, California
Pfizer Investigational Site
La Jolla, California, United States, 92037-7651
Pfizer Investigational Site
La Jolla, California, United States, 92093
United States, Louisiana
Pfizer Investigational Site
Shreveport, Louisiana, United States, 71105
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84112-5550
Austria
Pfizer Investigational Site
Senftenberg, Austria, A-3541
Bosnia and Herzegovina
Pfizer Investigational Site
Banja Luka, Bosnia and Herzegovina, 78000
Croatia
Pfizer Investigational Site
Varazdin, Croatia, 42000
Hungary
Pfizer Investigational Site
Szekesfehervar, Hungary, 8003
India
Pfizer Investigational Site
Nagpur, Maharashtra, India, 440 010
Pfizer Investigational Site
Nashik, Maharashtra, India, 422 005
Pfizer Investigational Site
Lucknow, Uttar Pradesh, India, 226003
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 120-752
Pfizer Investigational Site
Seoul, Korea, Republic of, 135-710
Latvia
Pfizer Investigational Site
Riga, Latvia, LV 1079
Poland
Pfizer Investigational Site
Bydgoszcz, Poland, 85-796
Pfizer Investigational Site
Gdansk, Poland, 80-208
Pfizer Investigational Site
Wloclawek, Poland, 87-800
Slovakia
Pfizer Investigational Site
Banska Bystrica, Slovakia, 975 17
Pfizer Investigational Site
Bratislava, Slovakia, 83310
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00830180     History of Changes
Other Study ID Numbers: A4091029
First Posted: January 27, 2009    Key Record Dates
Last Update Posted: March 31, 2014
Last Verified: March 2014

Keywords provided by Pfizer:
Cancer pain
NGF
open-label extension

Additional relevant MeSH terms:
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases