Open Label Extension In Cancer Patients

Study Overview
=================
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.

Official Title
-----------------
PHASE 2 OPEN-LABEL SAFETY EXTENSION STUDY OF TANEZUMAB IN CANCER PATIENTS WITH PAIN DUE TO BONE METASTASES

Conditions
-----------------
Neoplasms, Bone Metastases

Intervention / Treatment
-----------------
* Biological: Anti-NGF AB


Participation Criteria
=================
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 Exclusion Criteria: Patient was withdrawn from Study A4091003 for an adverse event or serious adverse event; Occurrence of any adverse event or condition during Study A4091003 or since termination from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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anti-NGF AB<br> | Biological: Anti-NGF AB<br>* Solution for injection, 10 mg, one injection/8 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline of Study A4091003, Baseline (A4091029) and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 | 
| 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. | Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 | 
| 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. | Baseline of Study A4091003, Baseline (A4091029) and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 | 
| 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. | Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 | 
| 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. | Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 | 
| 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. | Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 | 
| 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. | Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 | 
| 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. | Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 | 
| 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. | Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 | 
| 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. | Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 | 
| 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. | Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 | 
| 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. | Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer pain, NGF, open-label extension