Status:
COMPLETED
Open Label Extension In Cancer Patients
Lead Sponsor:
Pfizer
Conditions:
Neoplasms
Bone Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- Patient was withdrawn from Study A4091003 for an adverse event or serious adverse event;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.
Key Trial Info
Start Date :
October 29 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2013
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00830180
Start Date
October 29 2009
End Date
February 14 2013
Last Update
April 5 2021
Active Locations (23)
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1
UCSD Center for Pain Medicine
La Jolla, California, United States, 92037-7651
2
UCSD Medical Center - Thornton Hospital
La Jolla, California, United States, 92037-7651
3
UCSD Periman Ambulatory Care Center
La Jolla, California, United States, 92037-7651
4
UCSD Moores Cancer Center
La Jolla, California, United States, 92093