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 (Responsible Party):	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

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 ]
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 ]

Estimated Enrollment:	58
Study Start Date:	April 2009
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

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 36 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 by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00545129 History of Changes
Other Study ID Numbers:	A4091003
Study First Received:	October 15, 2007
Last Updated:	February 10, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Analgesics, Opioid
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on February 12, 2012