Open Label Extension In Cancer Patients

• ClinicalTrials.gov Identifier: NCT00830180
• Recruitment Status: Completed
• First Posted: January 27, 2009
• Last Update Posted: March 31, 2014
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: January 26, 2009
• First Posted Date: January 27, 2009
• Last Update Posted Date: March 31, 2014
• Study Start Date: October 2009
• Actual Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 23, 2009)

• Clinical laboratory tests [ Time Frame: 9 months ]
• Electrocardiograms [ Time Frame: 9 months ]
• Adverse events [ Time Frame: 9 months ]

Original Primary Outcome Measures (submitted: January 26, 2009)

• Clinical laboratory tests [ Time Frame: 6 months ]
• Electrocardiograms [ Time Frame: 6 months ]
• Adverse events [ Time Frame: 6 months ]

• Current Secondary Outcome Measures (submitted: September 23, 2009): Brief Pain Inventory [ Time Frame: 9 months ]

Original Secondary Outcome Measures (submitted: January 26, 2009)

• Brief Pain Inventory [ Time Frame: 6 months ]
• Karnofsky Performance Scale [ Time Frame: 6 months ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Open Label Extension In Cancer Patients
• Official Title: Phase II Open-Label Safety Extension Study Of Tanezumab In Cancer Patients With Pain Due To Bone Metastases
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Neoplasms
• Bone Metastases

Intervention

Biological: Anti-NGF AB

Solution for injection, 10 mg, one injection/8 weeks

Study Arms

Experimental: Anti-NGF AB

Intervention: Biological: Anti-NGF AB

• Publications *: Sopata M, Katz N, Carey W, Smith MD, Keller D, Verburg KM, West CR, Wolfram G, Brown MT. Efficacy and safety of tanezumab in the treatment of pain from bone metastases. Pain. 2015 Sep;156(9):1703-1713. doi: 10.1097/j.pain.0000000000000211.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 25, 2013): 41
• Original Estimated Enrollment (submitted: January 26, 2009): 100
• Actual Study Completion Date: February 2013
• Actual Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Bosnia and Herzegovina, Croatia, Hungary, India, Korea, Republic of, Latvia, Poland, Slovakia, United States
• Removed Location Countries: France, Hong Kong, Peru

Administrative Information

• NCT Number: NCT00830180
• Other Study ID Numbers: A4091029
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: March 2014