Open Label Extension In Cancer Patients

• ClinicalTrials.gov Identifier: NCT00830180
• Recruitment Status: Completed
• First Posted: January 27, 2009
• Results First Posted: February 2, 2021
• Last Update Posted: February 2, 2021
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

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.

Condition or disease	Intervention/treatment	Phase
Neoplasms; Bone Metastases	Biological: Anti-NGF AB	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 41 participants
• Allocation: Non-Randomized
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: PHASE 2 OPEN-LABEL SAFETY EXTENSION STUDY OF TANEZUMAB IN CANCER PATIENTS WITH PAIN DUE TO BONE METASTASES
• Actual Study Start Date: October 29, 2009
• Actual Primary Completion Date: February 14, 2013
• Actual Study Completion Date: February 14, 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Anti-NGF AB	Biological: Anti-NGF AB; Solution for injection, 10 mg, one injection/8 weeks

Outcome Measures

Primary Outcome Measures :

1. Change From Parent Study (A4091003) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Score for at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 [ Time Frame: At Baseline of Study A4091003, and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 ]
   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.
2. Change From A4091029 Baseline in BPI-sf Average Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 [ Time Frame: At Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 ]
   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.
3. Change From Parent Study (A4091003) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 [ Time Frame: At Baseline of Study A4091003, and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 ]
   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.
4. Change From Study A4091029 Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 [ Time Frame: At Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 ]
   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.
5. Change From Parent Study (A4091003) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 [ Time Frame: At Baseline of Study A4091003, and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 ]
   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.
6. Change From Study A4091029 Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 [ Time Frame: At Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 ]
   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.
7. Change From Parent Study (A4091003) Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 [ Time Frame: At Baseline of Study A4091003, and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 ]
   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.
8. Change From Study A4091029 Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 [ Time Frame: At Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 ]
   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.
9. Change From Parent Study (A4091003) Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) Weeks 4, 8, 16, 24, 40, 48, 56 and 64 [ Time Frame: At Baseline of Study A4091003, and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 ]
   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.
10. 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 [ Time Frame: At Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 ]
    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.
11. Change From Parent Study (A4091003) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 [ Time Frame: At Baseline of Study A4091003, and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 ]
    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.
12. Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 [ Time Frame: At Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029 ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

UCSD Center for Pain Medicine

La Jolla, California, United States, 92037-7651

UCSD Medical Center - Thornton Hospital

La Jolla, California, United States, 92037-7651

UCSD Periman Ambulatory Care Center

La Jolla, California, United States, 92037-7651

UCSD Moores Cancer Center

La Jolla, California, United States, 92093

United States, Louisiana

WK River Cities Clinical Research Center

Shreveport, Louisiana, United States, 71105

United States, Utah

Huntsman Cancer Institute

Salt Lake City, Utah, United States, 84112

Austria

Nuhr Zentrum

Senftenberg, Austria, A-3541

Bosnia and Herzegovina

Clinic of Oncology

Banja Luka, Bosnia and Herzegovina, 78000

Croatia

General Hospital Varazdin

Varazdin, Croatia, 42000

Hungary

Fejer Megyei Szt. Gyorgy Korhaz - Rendelointezet/Aneszteziologiai es Intenziv Betegellato Osztaly

Szekesfehervar, Hungary, 8003

India

Central India Cancer Research Institute Central India Cancer Research Institute

Nagpur, Maharashtra, India, 440 010

Shatabdi Super Speciality Hospital

Nashik, Maharashtra, India, 422 005

Chhatrapati Shahuji Maharaj Medical University

Lucknow, Uttar Pradesh, India, 226003

Korea, Republic of

Severance Hospital, Yonsei University College of Medicine

Seodaemun-gu, Seoul, Korea, Republic of, 120-752

Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine

Seoul, Korea, Republic of, 135-710

Latvia

Latvian Oncology Centre

Riga, Latvia, LV-1079

Poland

Niepubliczny Zaklad Opieki Zdrowotnej

Bydgoszcz, Poland, 85-796

Hospicjum im Ks Eugeniusza Dutkiewicza SAC w Gdansku

Gdansk, Poland, 80-208

**Poradnia Medycyny Paliatywnej, Hospicjum Palium

Poznan, Poland, 61-245

Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie

Poznan, Poland, 61-866

NZOZ Zespol Opieki Domowej Polskiego Towarzystwa Opieki Paliatywnej

Wloclawek, Poland, 87-800

Slovakia

Fakultna Nemocina s Poliklinikou FD Roosevelta Banska Bystrica

Banska Bystrica, Slovakia, 975 17

Narodny onkologicky ustav

Bratislava, Slovakia, 833 10

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00830180
• Other Study ID Numbers: A4091029; 2008-005182-66 ( EudraCT Number ); CANCER PAIN OL EXTENSION ( Other Identifier: Alias Study Number )
• First Posted: January 27, 2009
• Results First Posted: February 2, 2021
• Last Update Posted: February 2, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Keywords provided by Pfizer:

Cancer pain; NGF; open-label extension

Additional relevant MeSH terms:

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes