Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Cancer Pain

Pain

Neoplastic Processes

Pharmaceutical Solutions

All Drugs and Chemicals

Analgesics

Tanezumab

Solution for injection, 10 mg, one injection/8 weeks

Anti-NGF AB

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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.

Open Label Extension In Cancer Patients

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

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.

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.

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.

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.

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.

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.

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.

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.

Pfizer

The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.

Participants received a single intravenous (IV) infusion of tanezumab 10 milligram (mg) administered at Visit 1 (Baseline, Day 1), Visit 4 (Day 57, Week 8), Visit 6 (Day 113, Week 16), and Visit 7 (Day 169, Week 24). For participants in Poland entering the Extended-use Period, tanezumab 10 mg was also administered via IV infusion at Visit 9 (Day 282, Week 40), Visit 10 (Day 337, Week 48), Visit 11 (Day 393, Week 56), and Visit 12 (Day 449, Week 64) with a plus or minus 5 day window for each post-baseline IV infusion.

Tanezumab 10 mg (A4091029)

Age, Continuous

Sex: Female, Male

The intent to treat (ITT) analysis set included all participants who received at least 1 of IV study medication during study.

Pfizer ClinicalTrials.gov Call Center

Baseline (A4091029)

Week 4

Week 8

Week 16

Week 24

Week 40

Week 48

Week 56

Week 64

Participants who received placebo in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 mg administered at Visit 1 (Baseline, Day 1), Visit 4 (Day 57, Week 8), Visit 6 (Day 113, Week 16), and Visit 7 (Day 169, Week 24). Participants in Poland entering the Extended-Use Period, tanezumab 10 mg was also administered via IV infusion at Visit 9 (Day 282, Week 40), Visit 10 (Day 337, Week 48), Visit 11 (Day 393, Week 56), and Visit 12 (Day 449, Week 64) with a plus or minus 5 day window for each post-baseline IV infusion.

Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)

Participants who received tanezumab 10 mg in Study A4091003, were enrolled to Study A4091029 and received a single IV infusion of tanezumab 10 mg administered at Visit 1 (Baseline, Day 1), Visit 4 (Day 57, Week 8), Visit 6 (Day 113, Week 16), and Visit 7 (Day 169, Week 24). Participants in Poland entering the Extended-Use Period, tanezumab 10 mg was also administered via IV infusion at Visit 9 (Day 282, Week 40), Visit 10 (Day 337, Week 48), Visit 11 (Day 393, Week 56), and Visit 12 (Day 449, Week 64) with a plus or minus 5 day window for each post-baseline IV infusion.

Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029)

The Intent to Treat (ITT) Population: all participants who received at least day 1 dose of IV study medication during Study A4091029. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.

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

Week 4 (n=33)

Week 8 (n=29)

Week 16 (n=24)

Week 24 (n=21)

Week 40 (n=14)

Week 48 (n=1)

Week 56 (n=1)

Week 64 (n=1)

ITT Population. Here 'overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at each specified category of specified time point.

Change From A4091029 Baseline in BPI-sf Average Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64

Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64

Change From Study A4091029 Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64

Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64

Change From Study A4091029 Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64

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

Change From Study A4091029 Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64

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

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

General activity: Baseline

General activity: Week 4

General activity: Week 8

General activity: Week 16

General activity: Week 24

General activity: Week 40

General activity: Week 48

General activity: Week 56

General activity: Week 64

Mood: Baseline

Mood: Week 4

Mood: Week 8

Mood: Week 16

Mood: Week 24

Mood: Week 40

Mood: Week 48

Mood: Week 56

Mood: Week 64

Walking ability: Baseline

Walking ability: Week 4

Walking ability: Week 8

Walking ability: Week 16

Walking ability: Week 24

Walking ability: Week 40

Walking ability: Week 48

Walking ability: Week 56

Walking ability: Week 64

Normal work: Baseline

Normal work: Week 4

Normal work: Week 8

Normal work: Week 16

Normal work: Week 24

Normal work: Week 40

Normal work: Week 48

Normal work: Week 56

Normal work: Week 64

Relations with other people: Baseline

Relations with other people: Week 4

Relations with other people: Week 8

Relations with other people: Week 16

Relations with other people: Week 24

Relations with other people: Week 40

Relations with other people: Week 48

Relations with other people: Week 56

Relations with other people: Week 64

Sleep: Baseline

Sleep: Week 4

Sleep: Week 8

Sleep: Week 16

Sleep: Week 24

Sleep: Week 40

Sleep: Week 48

Sleep: Week 56

Sleep: Week 64

Enjoyment of life: Baseline

Enjoyment of life: Week 4

Enjoyment of life: Week 8

Enjoyment of life: Week 16

Enjoyment of life: Week 24

Enjoyment of life: Week 40

Enjoyment of life: Week 48

Enjoyment of life: Week 56

Enjoyment of life: Week 64

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

Walking ability: Week 4 (

Normal Work: Week 64

Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64

Overall Study

Spots Global Cancer Trial Database for Open Label Extension In Cancer Patients

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