A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone

Pfizer

Status and phase: Completed; Phase 2

Conditions: Neoplasm Metastasis; Palliative Care

Treatments: Drug: Tanezumab 10 mg IV; Drug: IV Placebo for tanezumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00545129

A4091003

CANCER PAIN POC (Other Identifier)

2008-005181-31 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to investigate the safety and efficacy of tanezumab in combination with opioids in treating pain due to cancer that has spread to bone.

Enrollment: 59 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 spread to bone, causing moderate to severe bone pain.
• Requires daily opioid medication

Exclusion criteria

• Patients who do not have bone pain caused by cancer are not eligible for the study.
• Patients who started chemotherapy less than 4 weeks ago, or who completed radiotherapy less than 4 weeks ago, are not eligible.
• Known history or evidence of osteoarthritis. History of significant trauma to a major joint within 1 year prior to Screening.
• Known history of rheumatoid arthritis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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59 participants in 2 patient groups, including a placebo group

Tanezumab 10 mg IV + opioids

Experimental group

Treatment:

Drug: Tanezumab 10 mg IV

Placebo + opioids

Placebo Comparator group

Description:

Single IV infusion of placebo for tanezumab on Day 1. Maintained on baseline opioid regimen.

Treatment:

Drug: IV Placebo for tanezumab