Clinical trial NCT00545129: A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neoplasm Metastasis
Palliative Care
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-10-17
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Week 6
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16
timeFrame: Baseline, Weeks 1, 2, 4, 8, 12, 16
measure: Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 12, 16
measure: Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 12, 16
measure: Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 12, 16
measure: Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: LOCF
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 12, 16
measure: Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 12, 16
measure: Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst Pain Scores Weeks 1, 2, 4, 6, 8, 12 and 16: LOCF
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 12, 16
measure: Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: BOCF
timeFrame: Week 1, 2, 4, 6, 8, 12, 16
measure: Percentage of Participants Achieving Greater Than or Equal to (>=) 30 Percent (%), >=50%, >=70% and >=90% Reduction in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score: LOCF
timeFrame: Week 1, 2, 4, 6, 8, 12, 16
measure: Average Daily Opioid Consumption
timeFrame: Opioid Dose Adjust Period (Day-30 to Day-4), Baseline Assessment period (Day-3 to Day-1), Post Baseline Period (Day 1 to Week 16)
measure: Number of Doses of Rescue Medication Required Per Week
timeFrame: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16
measure: Change From Baseline in Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 6, 12, and 16
timeFrame: Baseline, Week 2, 4, 6, 12, 16
measure: Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores of General Activity, Walking Ability and Normal Work at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 12, 16
measure: Change From Baseline in Brief Pain Inventory (BPI) Pain Interference With Function Composite Score and Individual Pain Interference Item Scores at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 12, 16
measure: Patient's Global Evaluation of Study Medication
timeFrame: Week 1, 2, 4, 6, 8, 12, 16
measure: Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: BOCF
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 12, 16
measure: Change From Baseline in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8, 12, and 16: LOCF
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 12, 16
measure: Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: BOCF
timeFrame: Week 1, 2, 4, 6, 8, 12, 16
measure: Percentage of Participants Achieving Improvement Of >=2 Points in Patient's Global Assessment Of Disease (Cancer Pain) Activity: LOCF
timeFrame: Week 1, 2, 4, 6, 8, 12, 16
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to 113 days
measure: Number of Participants With Physical Examination Abnormalities
timeFrame: Baseline up to Week 16 or Early Termination (up to 113 days)
measure: Number of Participants With Abnormal Neurological Examination
timeFrame: Week 2, 4, 6, 12, 16, Early Termination (up to 113 days)
measure: Vital Sign Examination: Body Temperature
timeFrame: Baseline (Day 1 0H), Week 2, 4, 6, 12, 16, Early Termination (up to 113 days)
measure: Vital Sign Examination: Blood Pressure (BP)
timeFrame: Baseline (Day 1 0H), Week 2, 4, 6, 12, 16, Early Termination (up to 113 days)
measure: Vital Sign Examination: Respiratory Rate
timeFrame: Baseline (Day 1, 0H), Week 2, 4, 6, 12, 16, Early Termination (up to 113 days)
measure: Vital Sign Examination: Heart Rate
timeFrame: Baseline (Day 1, 0H), Week 2, 4, 6, 12, 16, and Early Termination (up to 113 days)
measure: Body Weight of Participants
timeFrame: Baseline, Week 6, 16 and Early Termination (up to 113 days)
measure: Number of Participants With Abnormal Laboratory Examination
timeFrame: Baseline up to Week 16, Early Termination (up to 113 days)
measure: Number of Participants With Anti-drug Antibodies
timeFrame: Baseline (Day 1), Week 4, 6, 12, 16
measure: Electrocardiogram Examination
timeFrame: Baseline (Pre-dose and 1 hour Post-dose), Week 4, 16, Early Termination (up to 113 days)
measure: Electrocardiogram Examination: Heart Rate
timeFrame: Baseline (Pre-dose and 1 hour Post-dose), Week 4, 16, Early Termination (up to 113 days)
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Center for Pain Medicine
state: California
city: La Jolla
country: United States
facility: UCSD Medical Center - Thornton Hospital
state: California
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
city: South Bend
country: United States
facility: Indiana Pain and Spine Clinic
state: Indiana
city: Shreveport
country: United States
facility: WK River Cities Clinical Research Center
state: Louisiana
city: Shreveport
country: United States
facility: Willis Knighton Pierremont Health Center
state: Louisiana
city: Charleston
country: United States
facility: Hollings Cancer Center
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina, Department of Urology
state: South Carolina
city: Charleston
country: United States
facility: MUSC Department of Radiology
state: South Carolina
city: Charleston
country: United States
facility: MUSC Investigational Pharmacy
state: South Carolina
city: Charleston
country: United States
facility: MUSC Urology Ambulatory Care
state: South Carolina
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute at the University of Utah
state: Utah
city: Graz
country: Austria
facility: Landeskrankenhaus Graz - Universitaetsklinik fuer Orthopaedie und Orthopaedische Chirurgie
city: Linz
country: Austria
facility: Krankenhaus der Elisabethinen Linz, Institut fuer Anaesthesiologie und Intensivmedizin
city: Senftenberg
country: Austria
facility: Nuhr Zentrum
city: Banja Luka
country: Bosnia and Herzegovina
facility: Clinic of Oncology
city: Sarajevo
country: Bosnia and Herzegovina
facility: Institute of Oncology, University Clinical Center Sarajevo
city: Varazdin
country: Croatia
facility: General Hospital Varazdin
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Budapest
country: Hungary
facility: Fovarosi Onkormanyzat Peterfy Sandor Utcai Korhaz - Fajdalom Ambulancia
city: Budapest
country: Hungary
facility: Fovarosi Onkormanyzat Jahn Ferenc Del-pesti Korhaz - Fajdalom Ambulancia
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szt. Gyorgy Korhaz - Rendelointezet/Aneszteziologiai es Intenziv Betegellato Osztaly
city: Miraj
country: India
facility: Shri Siddhivinayak Ganpati Cancer Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Central India Cancer Research Institute
state: Maharashtra
city: Nashik
country: India
facility: Shatabdi Superspeciality Hospital
state: Maharashtra
city: Lucknow
country: India
facility: Chhatrapati Shahuji Maharaj Medical University
state: Uttar Pradesh
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute and Research Centre,
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine, Yonsei Cancer Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine
city: Riga
country: Latvia
facility: 10th Department, Latvian Oncological Centre / Riga Eastern Clinical University Hospital
city: Mexico
country: Mexico
facility: Centro de Cancer del Centro Medico ABC
state: Distrito Federal
city: Lima
country: Peru
facility: Hospital Nacional Guillermo Almenara Irigoyen
state: Lima L13
city: Lima
country: Peru
facility: Oncocare
city: Bydgoszcz
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej
city: Gdansk
country: Poland
facility: Hospicjum im. Ks. Eugeniusza Dutkiewicza SAC w Gdansku
city: Poznan
country: Poland
facility: Poradnia Medycyny Paliatywnej, Hospicjum Palium
city: Wloclawek
country: Poland
facility: NZOZ Zespol Opieki Domowej
city: Banska Bystrica
country: Slovakia
facility: Fakultna Nemocnica s Poliklinikou F.D.Roosevelta
city: Bratislava
country: Slovakia
facility: Narodny onkologicky ustav
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Sopata M, Katz N, Carey W, Smith MD, Keller D, Verburg KM, West CR, Wolfram G, Brown MT. Efficacy and safety of tanezumab in the treatment of pain from bone metastases. Pain. 2015 Sep;156(9):1703-1713. doi: 10.1097/j.pain.0000000000000211.
citation: 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.