Back to resultsOpen Label Extension In Cancer Patients
Primary Purpose
Neoplasms, Bone Metastases
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Anti-NGF AB
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasms focused on measuring Cancer pain, NGF, open-label extension
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- Patient was withdrawn from Study A4091003 for an adverse event or serious adverse event;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.
Sites / Locations
- UCSD Center for Pain Medicine
- UCSD Medical Center - Thornton Hospital
- UCSD Periman Ambulatory Care Center
- UCSD Moores Cancer Center
- WK River Cities Clinical Research Center
- Huntsman Cancer Institute
- Nuhr Zentrum
- Clinic of Oncology
- General Hospital Varazdin
- Fejer Megyei Szt. Gyorgy Korhaz - Rendelointezet/Aneszteziologiai es Intenziv Betegellato Osztaly
- Central India Cancer Research Institute Central India Cancer Research Institute
- Shatabdi Super Speciality Hospital
- Chhatrapati Shahuji Maharaj Medical University
- Severance Hospital, Yonsei University College of Medicine
- Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine
- Latvian Oncology Centre
- Niepubliczny Zaklad Opieki Zdrowotnej
- Hospicjum im Ks Eugeniusza Dutkiewicza SAC w Gdansku
- **Poradnia Medycyny Paliatywnej, Hospicjum Palium
- Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
- NZOZ Zespol Opieki Domowej Polskiego Towarzystwa Opieki Paliatywnej
- Fakultna Nemocina s Poliklinikou FD Roosevelta Banska Bystrica
- Narodny onkologicky ustav
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Anti-NGF AB
Arm Description
Outcomes
Primary Outcome Measures
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
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the average pain score, minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Change From A4091029 Baseline in BPI-sf Average Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the average pain score, minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the worst pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Change From Study A4091029 Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the worst pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the least pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Change From Study A4091029 Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the least pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
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
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the right now pain score (at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Change From Study A4091029 Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the right now pain score (at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
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
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference. The BPI-sf Pain Interference with Function Composite score is calculated as the average of the seven item subsets (questions 5A to G) in the BPI-sf questionnaire. If one of the seven items was missing then the average score of the remaining items was used to impute the missing (seventh) value. If more than one item was missing then the composite score was missing.
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
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference. The BPI-sf Pain Interference with Function Composite score is calculated as the average of the seven item subsets (questions 5A to G) in the BPI-sf questionnaire. If one of the seven items was missing then the average score of the remaining items was used to impute the missing (seventh) value. If more than one item was missing then the composite score was missing.
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
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Items are defined as interference with, general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life mood. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference.
Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Items are defined as interference with: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life mood. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00830180
Brief Title
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
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 29, 2009 (Actual)
Primary Completion Date
February 14, 2013 (Actual)
Study Completion Date
February 14, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Bone Metastases
Keywords
Cancer pain, NGF, open-label extension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anti-NGF AB
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Anti-NGF AB
Intervention Description
Solution for injection, 10 mg, one injection/8 weeks
Primary Outcome Measure Information:
Title
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
Description
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the average pain score, minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time Frame
Baseline of Study A4091003, Baseline (A4091029) and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Title
Change From A4091029 Baseline in BPI-sf Average Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
Description
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the average pain score, minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time Frame
Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Title
Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
Description
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the worst pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time Frame
Baseline of Study A4091003, Baseline (A4091029) and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Title
Change From Study A4091029 Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
Description
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the worst pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time Frame
Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Title
Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
Description
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the least pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time Frame
Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Title
Change From Study A4091029 Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
Description
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the least pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time Frame
Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Title
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
Description
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the right now pain score (at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time Frame
Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Title
Change From Study A4091029 Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
Description
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the right now pain score (at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time Frame
Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Title
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
Description
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference. The BPI-sf Pain Interference with Function Composite score is calculated as the average of the seven item subsets (questions 5A to G) in the BPI-sf questionnaire. If one of the seven items was missing then the average score of the remaining items was used to impute the missing (seventh) value. If more than one item was missing then the composite score was missing.
Time Frame
Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Title
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
Description
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference. The BPI-sf Pain Interference with Function Composite score is calculated as the average of the seven item subsets (questions 5A to G) in the BPI-sf questionnaire. If one of the seven items was missing then the average score of the remaining items was used to impute the missing (seventh) value. If more than one item was missing then the composite score was missing.
Time Frame
Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Title
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
Description
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Items are defined as interference with, general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life mood. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference.
Time Frame
Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Title
Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
Description
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Items are defined as interference with: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life mood. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference.
Time Frame
Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
UCSD Center for Pain Medicine
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-7651
Country
United States
Facility Name
UCSD Medical Center - Thornton Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-7651
Country
United States
Facility Name
UCSD Periman Ambulatory Care Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-7651
Country
United States
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
WK River Cities Clinical Research Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Nuhr Zentrum
City
Senftenberg
ZIP/Postal Code
A-3541
Country
Austria
Facility Name
Clinic of Oncology
City
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
General Hospital Varazdin
City
Varazdin
ZIP/Postal Code
42000
Country
Croatia
Facility Name
Fejer Megyei Szt. Gyorgy Korhaz - Rendelointezet/Aneszteziologiai es Intenziv Betegellato Osztaly
City
Szekesfehervar
ZIP/Postal Code
8003
Country
Hungary
Facility Name
Central India Cancer Research Institute Central India Cancer Research Institute
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440 010
Country
India
Facility Name
Shatabdi Super Speciality Hospital
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422 005
Country
India
Facility Name
Chhatrapati Shahuji Maharaj Medical University
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Facility Name
Severance Hospital, Yonsei University College of Medicine
City
Seodaemun-gu
State/Province
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Latvian Oncology Centre
City
Riga
ZIP/Postal Code
LV-1079
Country
Latvia
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Hospicjum im Ks Eugeniusza Dutkiewicza SAC w Gdansku
City
Gdansk
ZIP/Postal Code
80-208
Country
Poland
Facility Name
**Poradnia Medycyny Paliatywnej, Hospicjum Palium
City
Poznan
ZIP/Postal Code
61-245
Country
Poland
Facility Name
Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
City
Poznan
ZIP/Postal Code
61-866
Country
Poland
Facility Name
NZOZ Zespol Opieki Domowej Polskiego Towarzystwa Opieki Paliatywnej
City
Wloclawek
ZIP/Postal Code
87-800
Country
Poland
Facility Name
Fakultna Nemocina s Poliklinikou FD Roosevelta Banska Bystrica
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
Narodny onkologicky ustav
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
25919474
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091029&StudyName=Open%20Label%20Extension%20In%20Cancer%20Patients
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Open Label Extension In Cancer Patients
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