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

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ClinicalTrials.gov Identifier: NCT00545129
Recruitment Status : Completed
First Posted : October 17, 2007
Last Update Posted : January 18, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neoplasm Metastasis Palliative Care Drug: Tanezumab 10 mg IV Drug: IV Placebo for tanezumab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Randomized, Double-Blind, Placebo-Controlled Multicenter Efficacy And Safety Study Of Tanezumab As Add-On Therapy To Opioid Medication In Patients With Pain Due To Bone Metastases
Study Start Date : April 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : February 2012

Arm Intervention/treatment
Experimental: Tanezumab 10 mg IV + opioids Drug: Tanezumab 10 mg IV
Single IV infusion of 10 mg tanezumab on Day 1. Maintained on baseline opioid regimen.
Placebo Comparator: Placebo + opioids
Single IV infusion of placebo for tanezumab on Day 1. Maintained on baseline opioid regimen.
Drug: IV Placebo for tanezumab
Single IV infusion of placebo for tanezumab on Day 1. Maintained on baseline opioid regimen.



Primary Outcome Measures :
  1. Change from Baseline to Week 6 in daily average pain intensity measured by the 11 point Pain Intensity Numerical Rating Scale (NRS; 0-10). Baseline is the average daily Pain NRS score during Stabilization Phase prior to Randomization (3 days). [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Physical examination at Screening, Week 6 and Week 16 (or at early termination). [ Time Frame: 16 weeks ]
  2. Change from Baseline to Weeks 1, 2, 4, 8, 12 and 16 in the daily average pain intensity NRS score. [ Time Frame: 16 weeks ]
  3. Change from Baseline to Weeks 1, 2, 4, 6, 8, 12 and 16 in the daily worst pain intensity NRS score. [ Time Frame: 16 weeks ]
  4. Average number of doses of rescue medication required per week (up to Week 16). [ Time Frame: 16 weeks ]
  5. Clinical laboratory assessments (hematology, blood chemistry, PT/PTT, urinalysis) at Screening, Baseline, and Weeks 2, 4, 6, 12 and 16 (or at early termination). [ Time Frame: 16 weeks ]
  6. Change in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12 and 16. [ Time Frame: 16 weeks ]
  7. Response as defined by a ≥30/50/70/90% reduction from Baseline in the daily average pain intensity NRS score. [ Time Frame: 16 weeks ]
  8. Vital sign measurements at Screening, Baseline, and Weeks 2, 4, 6, 12, and 16 (or at early termination). [ Time Frame: 16 weeks ]
  9. Neurologic examination at Screening, Baseline, and Weeks 2, 4, 6, 12, and 16 (or at early termination). [ Time Frame: 16 weeks ]
  10. Weight measurements at Screening, Week 6 and Week 16 (or at early termination). [ Time Frame: 16 weeks ]
  11. Change from Baseline to Weeks 1, 2, 4, 6, 8, 12 and 16, in the BPI worst pain scores obtained at study visits. [ Time Frame: 16 weeks ]
  12. Change in the weekly Opioid Related Symptom Distress Scale at Weeks 2, 4, 6, 12 and 16. [ Time Frame: 16 weeks ]
  13. Change from Baseline to Weeks 1, 2, 4, 6, 8, 12 and 16, in the Brief Pain Inventory (BPI) average pain scores obtained at study visits. [ Time Frame: 16 weeks ]
  14. Anti-Drug Antibody testing at Baseline and Weeks 4, 6, 12 and 16 (or at early termination). [ Time Frame: 16 weeks ]
  15. Adverse events from time of first dose of study treatment through the last patient visit. [ Time Frame: 16 weeks ]
  16. Patient's Global Evaluation of Study Medication at Weeks 1, 2, 4, 6, 8, 12 and 16. [ Time Frame: 16 weeks ]
  17. Average daily opioid consumption (up to Week 16). [ Time Frame: 16 weeks ]
  18. ECG at Baseline (predosing and 1 hr post-dose) and Weeks 4 and 16 (or at early termination). [ Time Frame: 16 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545129


  Show 34 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00545129     History of Changes
Other Study ID Numbers: A4091003
First Posted: October 17, 2007    Key Record Dates
Last Update Posted: January 18, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents