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Open Label Extension In Cancer Patients

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
La Jolla, California, 92037-7651 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms, Bone Metastases
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patient was withdrawn from Study A4091003 for an adverse event or serious adverse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.

NCT00830180
Pfizer
Completed
Open Label Extension In Cancer Patients

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Open Label Extension In Cancer Patients
Phase II Open-Label Safety Extension Study Of Tanezumab In Cancer Patients With Pain Due To Bone Metastases
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Neoplasms
  • Bone Metastases
Biological: Anti-NGF AB
Solution for injection, 10 mg, one injection/8 weeks
Experimental: Anti-NGF AB
Intervention: Biological: Anti-NGF AB
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.
 
Completed
41
February 2013
February 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Bosnia and Herzegovina,   Croatia,   Hungary,   India,   Korea, Republic of,   Latvia,   Poland,   Slovakia,   United States
France,   Hong Kong,   Peru
 
NCT00830180
A4091029
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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