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Open Label Extension In Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00830180
First received: January 26, 2009
Last updated: March 3, 2014
Last verified: March 2014
  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
Neoplasms
Bone Metastases
Biological: Anti-NGF AB
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Clinical laboratory tests [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Electrocardiograms [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Brief Pain Inventory [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: October 2009
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anti-NGF AB 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 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  • Patient was withdrawn from Study A4091003 for an adverse event or serious adverse event;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.
  Contacts and Locations
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, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00830180     History of Changes
Other Study ID Numbers: A4091029
Study First Received: January 26, 2009
Last Updated: March 3, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014