Clinical trial NCT00830180: Open Label Extension In Cancer Patients
Official title: PHASE 2 OPEN-LABEL SAFETY EXTENSION STUDY OF TANEZUMAB IN CANCER PATIENTS WITH PAIN DUE TO BONE METASTASES
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neoplasms
Bone Metastases
Keywords: Cancer pain
NGF
open-label extension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-27
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of anti-NGF AB in cancer patients with pain due to bone metastases who participated in the double-blind Study A4091003 and who wish to receive open-label therapy.


Eligibility criteria: Inclusion Criteria:

* Prostate cancer, breast cancer, renal cell carcinoma or multiple myeloma that has been diagnosed as having metastasized to bone;
* Karnofsky Performance Score ≥40% at Baseline;
* patients randomized and treated with intravenous study drug in double-blind Study A4091003.

Exclusion Criteria:

* Patient was withdrawn from Study A4091003 for an adverse event or serious adverse event;
* Occurrence of any adverse event or condition during Study A4091003 or since termination from that study that, in the opinion of the Investigator, would put the patient at increased safety risk or should exclude the subject from participating in the open-label extension Study A4091029.

Primary outcomes:
measure: Change From Parent Study (A4091003 [NCT00545129]) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Score for at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
timeFrame: Baseline of Study A4091003, Baseline (A4091029) and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
measure: Change From A4091029 Baseline in BPI-sf Average Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
timeFrame: Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
measure: Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
timeFrame: Baseline of Study A4091003, Baseline (A4091029) and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
measure: Change From Study A4091029 Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
timeFrame: Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
measure: Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
timeFrame: Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
measure: Change From Study A4091029 Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
timeFrame: Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
measure: Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
timeFrame: Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
measure: Change From Study A4091029 Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
timeFrame: Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
measure: Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) Weeks 4, 8, 16, 24, 40, 48, 56 and 64
timeFrame: Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
measure: Change From Study A4091029 Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
timeFrame: Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
measure: Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
timeFrame: Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
measure: Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
timeFrame: Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Secondary outcomes:
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 Periman Ambulatory Care Center
state: California
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
city: Shreveport
country: United States
facility: WK River Cities Clinical Research Center
state: Louisiana
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Senftenberg
country: Austria
facility: Nuhr Zentrum
city: Banja Luka
country: Bosnia and Herzegovina
facility: Clinic of Oncology
city: Varazdin
country: Croatia
facility: General Hospital Varazdin
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szt. Gyorgy Korhaz - Rendelointezet/Aneszteziologiai es Intenziv Betegellato Osztaly
city: Nagpur
country: India
facility: Central India Cancer Research Institute Central India Cancer Research Institute
state: Maharashtra
city: Nashik
country: India
facility: Shatabdi Super Speciality Hospital
state: Maharashtra
city: Lucknow
country: India
facility: Chhatrapati Shahuji Maharaj Medical University
state: Uttar Pradesh
city: Seodaemun-gu
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine
city: Riga
country: Latvia
facility: Latvian Oncology Centre
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: Poznan
country: Poland
facility: Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
city: Wloclawek
country: Poland
facility: NZOZ Zespol Opieki Domowej Polskiego Towarzystwa Opieki Paliatywnej
city: Banska Bystrica
country: Slovakia
facility: Fakultna Nemocina s Poliklinikou FD Roosevelta Banska Bystrica
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.