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

Purpose

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

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

MedlinePlus related topics:

Cancer Palliative Care

Drug Information available for:

BaseLine

U.S. FDA Resources

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

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:

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 ]
Physical examination at Screening, Week 6 and Week 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 ]
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 ]
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 ]
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 ]
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 ]

Estimated Enrollment:	58
Study Start Date:	October 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 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

Locations


United States, Arizona
	Pfizer Investigational Site
	Litchfield Park, Arizona, United States, 85340
	Pfizer Investigational Site
	Sun City, Arizona, United States, 85351

United States, California
	Pfizer Investigational Site
	Antioch, California, United States, 94509
	Pfizer Investigational Site
	Walnut Creek, California, United States, 94598
	Pfizer Investigational Site
	San Leandro, California, United States, 94578
	Pfizer Investigational Site
	Concord, California, United States, 94520

United States, New Jersey
	Pfizer Investigational Site
	Hackensack, New Jersey, United States, 07601
	Pfizer Investigational Site
	Teaneck, New Jersey, United States, 07666

United States, Ohio
	Pfizer Investigational Site
	Middletown, Ohio, United States, 45042

United States, South Carolina
	Pfizer Investigational Site
	Myrtle Beach, South Carolina, United States, 29572

United States, Texas
	Pfizer Investigational Site
	Beaumont, Texas, United States, 77701

United States, Utah
	Pfizer Investigational Site
	Ogden, Utah, United States, 84403-3274

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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

Responsible Party:	Pfizer Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A4091003
First Received:	October 15, 2007
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00545129
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neoplasm Metastasis

Pain

Additional relevant MeSH terms:

Neoplasms

Neoplastic Processes

Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2008

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