Open Label Extension In Cancer Patients

Pfizer

Status and phase: Completed; Phase 2

Conditions: Neoplasms; Bone Metastases

Treatments: Biological: Anti-NGF AB

Study type: Interventional

Funder types: Industry

Identifiers

NCT00830180

2008-005182-66 (EudraCT Number)

CANCER PAIN OL EXTENSION (Other Identifier)

A4091029

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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• Patient was withdrawn from Study A4091003 for an adverse event or serious adverse event;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

Trial design

41 participants in 1 patient group

Anti-NGF AB

Experimental group

Treatment:

Biological: Anti-NGF AB