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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00545129

Purpose

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	Intervention	Phase
Neoplasm Metastasis Palliative Care	Drug: Tanezumab 10 mg IV Drug: IV Placebo for tanezumab	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Palliative Care

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]
Time to a ≥30% reduction from Baseline in the daily average pain intensity NRS score (sustained for a minimum of 4 consecutive days). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
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). [ 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 ]
Time to a ≥50% reduction from Baseline in the daily average pain intensity NRS score (sustained for a minimum of 4 consecutive days). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
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 ]
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 ]
Total duration of response as defined by days with ≥50% reduction from Baseline in the daily average pain intensity NRS score. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
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 mBPI 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: No ]
Change from Baseline to Weeks 1, 2, 4, 6, 8, 12 and 16, in the mBPI Pain Interference with Function Composite Score and individual pain interference item scores obtained at study visits. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Change from Baseline to Weeks 1, 2, 4, 6, 8, 12 and 16, in the modified Brief Pain Inventory (mBPI) average pain scores obtained at study visits. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
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). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Response as defined by a ≥30% reduction from Baseline in the daily average pain intensity NRS score at Weeks 1, 2, 4, 6, 8, 12 and 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Response as defined by a ≥50% reduction from Baseline in the daily average pain intensity NRS score at Weeks 1, 2, 4, 6, 8, 12 and 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Total duration of response as defined by days with ≥30% reduction from Baseline in the daily average pain intensity NRS score. [ 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: Yes ]
Adverse events from time of first dose of study treatment through the last patient visit. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
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 ]

Estimated Enrollment:	58
Study Start Date:	April 2009
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Tanezumab 10 mg IV + opioids: Experimental	Drug: Tanezumab 10 mg IV Single IV infusion of 10 mg tanezumab on Day 1. Maintained on baseline opioid regimen.
Placebo + opioids: Placebo Comparator 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Prostate cancer or breast cancer 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545129

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 30 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A4091003
Study First Received:	October 15, 2007
Last Updated:	January 15, 2010
ClinicalTrials.gov Identifier:	NCT00545129 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Physiological Effects of Drugs
Central Nervous System Depressants
Pharmacologic Actions
Neoplasms
Neoplastic Processes
Pathologic Processes
Sensory System Agents

Therapeutic Uses
Neoplasm Metastasis
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010