Phase 3 Study on the Efficacy and Safety of Tanezumab in Patients With Cancer Pain Due to Bone Metastasis Who Are Taking Background Opioid Therapy.

  • STATUS
    Not Recruiting
  • days left to enroll
    14
  • participants needed
    155
  • sponsor
    Pfizer
Updated on 16 June 2021
Investigator
Pfizer CT.gov Call Center
Primary Contact
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral (0.6 mi away) Contact
+128 other location
opioid
cancer
metastasis
bone metastases

Summary

The purpose of this study is to determine whether tanezumab is effective in the treatment of cancer pain due to bone metastasis in patients already taking background opioid therapy.

Description

This is a randomized, double-blind, placebo-controlled, multicenter, parallel-group Phase 3 study in cancer subjects requiring treatment with background opioids for pain due to bone metastasis.

Approximately 144 subjects will be randomized to one of 2 treatment groups in a 1:1 ratio (approximately 72 subjects per group). Subjects will receive a total of 3 subcutaneous injections, separated by 8 weeks in addition to background opioids administered throughout the study.

Treatment groups will include: 1. Placebo SC (matching tanezumab SC) in addition to background opioid therapy. 2. Tanezumab 20 mg SC in addition to background opioid therapy.

The study consists of three periods: Pre-Treatment (up to 37 days), Double-Blind Treatment (24 weeks) and Safety Follow-up (24 weeks).

Details
Condition Metastasis, Pain, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Liver Metastases, Bone Metastases, Pediatric Health, Near-Sighted Corrective Surgery, Post-Surgical Pain, Peripheral Arterial Occlusive Disease, Brain Metastases, Brain Function, Musculoskeletal Pain, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Pain (Pediatric), Metastatic Triple-Negative Breast Cancer, Metastatic Cancer, Neoplasm Metastasis
Treatment Tanezumab
Clinical Study IdentifierNCT02609828
SponsorPfizer
Last Modified on16 June 2021

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