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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00545129
First received: October 15, 2007
Last updated: January 10, 2013
Last verified: January 2013

October 15, 2007
January 10, 2013
April 2009
December 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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).
Complete list of historical versions of study NCT00545129 on ClinicalTrials.gov Archive Site
  • Physical examination at Screening, Week 6 and Week 16 (or at early termination). [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Change from Baseline to Weeks 1, 2, 4, 8, 12 and 16 in the daily average pain intensity NRS score. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Average number of doses of rescue medication required per week (up to Week 16). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Response as defined by a ≥30/50/70/90% reduction from Baseline in the daily average pain intensity NRS score. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Vital sign measurements at Screening, Baseline, and Weeks 2, 4, 6, 12, and 16 (or at early termination). [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Neurologic examination at Screening, Baseline, and Weeks 2, 4, 6, 12, and 16 (or at early termination). [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Weight measurements at Screening, Week 6 and Week 16 (or at early termination). [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in the weekly Opioid Related Symptom Distress Scale at Weeks 2, 4, 6, 12 and 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Anti-Drug Antibody testing at Baseline and Weeks 4, 6, 12 and 16 (or at early termination). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Adverse events from time of first dose of study treatment through the last patient visit. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Patient's Global Evaluation of Study Medication at Weeks 1, 2, 4, 6, 8, 12 and 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Average daily opioid consumption (up to Week 16). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • ECG at Baseline (predosing and 1 hr post-dose) and Weeks 4 and 16 (or at early termination). [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Average daily opioid consumption (up to Week 12).
  • Average number of doses of rescue medication required per week (up to Week 12).
  • Change in the weekly Opioid Related Symptom Distress Scale at Weeks 1, 2, 3, 4, 6, 8, 10, and 12
  • Change from Baseline to Weeks 1, 2, 4, 6, 8, and 12, in the mBPI Pain Interference with Function Composite Score and individual pain interference item scores obtained at study visits.
  • Patient's Global Evaluation of Study Medication at Weeks 1, 2, 4, 6, 8, and 12.
  • Change in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8 and 12.
  • Adverse events from time of first dose of study treatment through the last patient visit.
  • Physical examination at Screening, Week 8 and Week 16 (or at early termination).
  • Neurologic examination at Screening, Baseline, and Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16 (or at early termination).
  • Vital sign measurements at Screening, Baseline, and Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16 (or at early termination).
  • Weight measurements at Screening, Week 8 and Week 16 (or at early termination).
  • Clinical laboratory assessments (hematology, blood chemistry, PT/PTT, urinalysis) at Screening, Baseline, and Weeks 2, 4, 8, 12 and 16 (or at early termination).
  • Human Anti Human Antibody testing at Baseline and Weeks 4, 8, 12 and 16 (or at early termination).
  • ECG at Baseline (predosing and 1 hr post-dose) and Weeks 4, and 16 (or at early termination).
  • Change from Baseline to Weeks 1, 2, 4, 8 and 12 in the daily average pain intensity NRS score.
  • Change from Baseline to Weeks 1, 2, 4, 6, 8 and 12 in the daily worst pain intensity NRS score.
  • Change from Baseline to Weeks 5-12 and 5-8 in the daily average pain intensity NRS score.
  • Change from Baseline to Weeks 5-12 and 5-8 in the daily worst pain intensity NRS score.
  • Change from Baseline to Weeks 1, 2, 4, 6, 8 and 12, in the modified Brief Pain Inventory (mBPI) average pain scores obtained at study visits.
  • Change from Baseline to Weeks 1, 2, 4, 6, 8 and 12, in the mBPI worst pain scores obtained at study visits.
  • Response as defined by a ≥30% reduction from Baseline in the daily average pain intensity NRS score (sustained for a minimum of 4 consecutive days).
  • Response as defined by a ≥50% reduction from Baseline in the daily average pain intensity NRS score (sustained for a minimum of 4 consecutive days).
  • Response as defined by a ≥30% reduction from Baseline in the daily average pain intensity NRS score at Weeks 1, 2, 4, 6, 8, and 12.
  • Response as defined by a ≥50% reduction from Baseline in the daily average pain intensity NRS score at Weeks 1, 2, 4, 6, 8, and 12.
  • Time to a ≥30% reduction from Baseline in the daily average pain intensity NRS score (sustained for a minimum of 4 consecutive days).
  • Time to a ≥50% reduction from Baseline in the daily average pain intensity NRS score (sustained for a minimum of 4 consecutive days).
  • Total duration of response as defined by days with ≥30% reduction from Baseline in the daily average pain intensity NRS score.
  • Total duration of response as defined by days with ≥50% reduction from Baseline in the daily average pain intensity NRS score.
Not Provided
Not Provided
 
A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Neoplasm Metastasis
  • Palliative Care
  • Drug: Tanezumab 10 mg IV
    Single IV infusion of 10 mg 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.
  • Experimental: Tanezumab 10 mg IV + opioids
    Intervention: Drug: Tanezumab 10 mg IV
  • Placebo Comparator: Placebo + opioids
    Single IV infusion of placebo for tanezumab on Day 1. Maintained on baseline opioid regimen.
    Intervention: Drug: IV Placebo for tanezumab
Bapat AA, Hostetter G, Von Hoff DD, Han H. Perineural invasion and associated pain in pancreatic cancer. Nat Rev Cancer. 2011 Sep 23;11(10):695-707. doi: 10.1038/nrc3131. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
February 2012
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of,   United States,   Austria,   Bosnia and Herzegovina,   Croatia,   France,   Hungary,   India,   Slovakia,   Latvia,   Mexico,   Peru,   Poland
 
NCT00545129
A4091003
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP