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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

Tracking Information
First Submitted Date  ICMJE January 26, 2009
First Posted Date  ICMJE January 27, 2009
Last Update Posted Date March 31, 2014
Study Start Date  ICMJE October 2009
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: January 26, 2009)
  • Clinical laboratory tests [ Time Frame: 6 months ]
  • Electrocardiograms [ Time Frame: 6 months ]
  • Adverse events [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2009)
Brief Pain Inventory [ Time Frame: 9 months ]
Original Secondary Outcome Measures  ICMJE
 (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  ICMJE Open Label Extension In Cancer Patients
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neoplasms
  • Bone Metastases
Intervention  ICMJE Biological: Anti-NGF AB
Solution for injection, 10 mg, one injection/8 weeks
Study Arms  ICMJE 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):1703-13. doi: 10.1097/j.pain.0000000000000211.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2013)
41
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2009)
100
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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  ICMJE NCT00830180
Other Study ID Numbers  ICMJE A4091029
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP