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Phase II Open-Label Safety Extension Study Of Tanezumab In Cancer Patients With Pain Due To Bone Metastases


Phase 2
18 Years
N/A
Not Enrolling
Both
Neoplasms, Bone Metastases

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Trial Information

Phase II Open-Label Safety Extension Study Of Tanezumab In Cancer Patients With Pain Due To Bone Metastases


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- Patient was withdrawn from Study A4091003 for an adverse event or serious adverse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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical laboratory tests

Outcome Time Frame:

9 months

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A4091029

NCT ID:

NCT00830180

Start Date:

October 2009

Completion Date:

February 2013

Related Keywords:

  • Neoplasms
  • Bone Metastases
  • Cancer pain
  • NGF
  • open-label extension
  • Neoplasms
  • Neoplasm Metastasis
  • Bone Neoplasms
  • Bone Marrow Diseases

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteShreveport, Louisiana  71103
Pfizer Investigational SiteSalt Lake City, Utah  84112