Open Label Extension In Cancer Patients

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00830180
• Other study ID #: A4091029
• Secondary ID: 2008-005182-66CA
• Status: Completed
• Phase: Phase 2
• Start date: October 29, 2009
• Est. completion date: February 14, 2013

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 14, 2013
• Est. primary completion date: February 14, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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• Patient was withdrawn from Study A4091003 for an adverse event or serious adverse event;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.

Related Conditions & MeSH terms

• Bone Metastases
• Neoplasm Metastasis
• Neoplasms

Intervention

Biological:
• Anti-NGF AB
Solution for injection, 10 mg, one injection/8 weeks

Locations

Country	Name	City	State
Austria	Nuhr Zentrum	Senftenberg
Bosnia and Herzegovina	Clinic of Oncology	Banja Luka
Croatia	General Hospital Varazdin	Varazdin
Hungary	Fejer Megyei Szt. Gyorgy Korhaz - Rendelointezet/Aneszteziologiai es Intenziv Betegellato Osztaly	Szekesfehervar
India	Chhatrapati Shahuji Maharaj Medical University	Lucknow	Uttar Pradesh
India	Central India Cancer Research Institute Central India Cancer Research Institute	Nagpur	Maharashtra
India	Shatabdi Super Speciality Hospital	Nashik	Maharashtra
Korea, Republic of	Severance Hospital, Yonsei University College of Medicine	Seodaemun-gu	Seoul
Korea, Republic of	Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine	Seoul
Latvia	Latvian Oncology Centre	Riga
Poland	Niepubliczny Zaklad Opieki Zdrowotnej	Bydgoszcz
Poland	Hospicjum im Ks Eugeniusza Dutkiewicza SAC w Gdansku	Gdansk
Poland	**Poradnia Medycyny Paliatywnej, Hospicjum Palium	Poznan
Poland	Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie	Poznan
Poland	NZOZ Zespol Opieki Domowej Polskiego Towarzystwa Opieki Paliatywnej	Wloclawek
Slovakia	Fakultna Nemocina s Poliklinikou FD Roosevelta Banska Bystrica	Banska Bystrica
Slovakia	Narodny onkologicky ustav	Bratislava
United States	UCSD Center for Pain Medicine	La Jolla	California
United States	UCSD Medical Center - Thornton Hospital	La Jolla	California
United States	UCSD Moores Cancer Center	La Jolla	California
United States	UCSD Periman Ambulatory Care Center	La Jolla	California
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	WK River Cities Clinical Research Center	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Austria,  Bosnia and Herzegovina,  Croatia,  Hungary,  India,  Korea, Republic of,  Latvia,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

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