Open Label Extension In Cancer Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms; Bone Metastases
• Intervention / Treatment: Biological: Anti-NGF AB

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Senftenberg, Austria, A-3541
    • Nuhr Zentrum
• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
    • Clinic of Oncology
• Croatia
  • Varazdin, Croatia, 42000
    • General Hospital Varazdin
• Hungary
  • Szekesfehervar, Hungary, 8003
    • Fejer Megyei Szt. Gyorgy Korhaz - Rendelointezet/Aneszteziologiai es Intenziv Betegellato Osztaly
• India
  • Maharashtra
    • Nagpur, Maharashtra, India, 440 010
      • Central India Cancer Research Institute Central India Cancer Research Institute
    • Nashik, Maharashtra, India, 422 005
      • Shatabdi Super Speciality Hospital
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226003
      • Chhatrapati Shahuji Maharaj Medical University
• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine
  • Seoul
    • Seodaemun-gu, Seoul, Korea, Republic of, 120-752
      • Severance Hospital, Yonsei University College of Medicine
• Latvia
  • Riga, Latvia, LV-1079
    • Latvian Oncology Centre
• Poland
  • Bydgoszcz, Poland, 85-796
    • Niepubliczny Zaklad Opieki Zdrowotnej
  • Gdansk, Poland, 80-208
    • Hospicjum im Ks Eugeniusza Dutkiewicza SAC w Gdansku
  • Poznan, Poland, 61-866
    • Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
  • Poznan, Poland, 61-245
    • **Poradnia Medycyny Paliatywnej, Hospicjum Palium
  • Wloclawek, Poland, 87-800
    • NZOZ Zespol Opieki Domowej Polskiego Towarzystwa Opieki Paliatywnej
• Slovakia
  • Banska Bystrica, Slovakia, 975 17
    • Fakultna Nemocina s Poliklinikou FD Roosevelta Banska Bystrica
  • Bratislava, Slovakia, 833 10
    • Narodny Onkologicky Ustav
• United States
  • California
    • La Jolla, California, United States, 92093
      • UCSD Moores Cancer Center
    • La Jolla, California, United States, 92037-7651
      • 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
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • WK River Cities Clinical Research Center
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2009
• Primary Completion (Actual): February 14, 2013
• Study Completion (Actual): February 14, 2013

Study Registration Dates

• First Submitted: January 26, 2009
• First Submitted That Met QC Criteria: January 26, 2009
• First Posted (Estimate): January 27, 2009

Study Record Updates

• Last Update Posted (Actual): April 5, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Cancer pain; open-label extension; NGF
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: A4091029; 2008-005182-66 (EudraCT Number); CANCER PAIN OL EXTENSION (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.