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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02609828




Registration number
NCT02609828
Ethics application status
Date submitted
26/10/2015
Date registered
20/11/2015

Titles & IDs
Public title
Phase 3 Study on the Efficacy and Safety of Tanezumab in Patients With Cancer Pain Due to Bone Metastasis Who Are Taking Background Opioid Therapy
Scientific title
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB (PF-04383119) IN SUBJECTS WITH CANCER PAIN PREDOMINANTLY DUE TO BONE METASTASIS RECEIVING BACKGROUND OPIOID THERAPY
Secondary ID [1] 0 0
2013-002223-42
Secondary ID [2] 0 0
A4091061
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone Metastasis 0 0
Cancer Pain 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Children's - Other
Cancer 0 0 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tanezumab

Experimental: Arm 1 - Tanezumab 20 mg subcutaneously

Placebo comparator: Arm 2 - Placebo matched to active treatment subcutaneously


Treatment: Drugs: Tanezumab
Subcutaneous study treatment (tanezumab 20 mg or matched placebo) dosed at 8 week intervals.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in the Daily Average Pain Intensity Numerical Rating Score (NRS) in the Index Bone Metastasis Cancer Pain Site at Week 8
Timepoint [1] 0 0
Baseline, Week 8
Secondary outcome [1] 0 0
Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24
Timepoint [1] 0 0
Baseline, Weeks 1, 2, 4, 6, 12, 16 and 24
Secondary outcome [2] 0 0
Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Timepoint [2] 0 0
Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Secondary outcome [3] 0 0
Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Timepoint [3] 0 0
Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Secondary outcome [4] 0 0
Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Timepoint [4] 0 0
Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Secondary outcome [5] 0 0
Change From Baseline in the Daily Average Pain Intensity NRS Score in the Non-Index Visceral Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Timepoint [5] 0 0
Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Secondary outcome [6] 0 0
Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Non-Index Visceral Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Timepoint [6] 0 0
Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Secondary outcome [7] 0 0
Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Timepoint [7] 0 0
Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Secondary outcome [8] 0 0
Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Timepoint [8] 0 0
Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Secondary outcome [9] 0 0
Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24
Timepoint [9] 0 0
Baseline, Weeks 2, 4, 8, 16 and 24
Secondary outcome [10] 0 0
Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24
Timepoint [10] 0 0
Baseline, Weeks 2, 4, 8, 16 and 24
Secondary outcome [11] 0 0
Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Timepoint [11] 0 0
Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Secondary outcome [12] 0 0
Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Timepoint [12] 0 0
Weeks 1, 2, 4, 6, 8, 12, 16 and 24
Secondary outcome [13] 0 0
Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24
Timepoint [13] 0 0
Baseline, Weeks 2, 4, 8, 16, and 24
Secondary outcome [14] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timepoint [14] 0 0
Day 1 of dosing up to 24 weeks post last dose (maximum up to Week 48)
Secondary outcome [15] 0 0
Number of Participants With Laboratory Abnormalities (Normal Baseline)
Timepoint [15] 0 0
Baseline (Day 1, before dosing) up to Week 48
Secondary outcome [16] 0 0
Number of Participants With Laboratory Abnormalities (Abnormal Baseline)
Timepoint [16] 0 0
Baseline (Day 1, before dosing) up to Week 48
Secondary outcome [17] 0 0
Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period
Timepoint [17] 0 0
Baseline (Day 1, before dosing) up to Week 24
Secondary outcome [18] 0 0
Number of Participants With Categorical Summary of Electrocardiogram (ECG) (QTC) Data
Timepoint [18] 0 0
Baseline (Day 1, before dosing) up to Week 24
Secondary outcome [19] 0 0
Number of Participants With Confirmed Orthostatic Hypotension
Timepoint [19] 0 0
Baseline (Day 1, before dosing), Weeks 8, 16, 24 and 48
Secondary outcome [20] 0 0
Number of Participants With Clinically Significant Findings in Weight Measurement, Counted as an AE
Timepoint [20] 0 0
Day 1 of dosing up to maximum of Week 48
Secondary outcome [21] 0 0
Number of Participants With Abnormal Physical Examination at Screening
Timepoint [21] 0 0
Screening (up to 37 days prior to Day 1)
Secondary outcome [22] 0 0
Number of Participants With Individual Adjudicated Joint Safety Outcome/Event
Timepoint [22] 0 0
During the study, maximum up to Week 48
Secondary outcome [23] 0 0
Number of Participants With At Least 1 Total Joint Replacements (TJR)
Timepoint [23] 0 0
During the study, maximum up to Week 48
Secondary outcome [24] 0 0
Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Anti-Drug Antibodies (NAb)
Timepoint [24] 0 0
Baseline (Day 1, before dosing) up to Week 48

Eligibility
Key inclusion criteria
* Personally signed and dated informed consent document.
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Male or female, =18 years of age
* Weight =40 kg at Screening
* Cancer diagnosed as having metastasized to bone or multiple myeloma.
* Imaging confirmation of bone metastasis at Screening or within 120 days prior to the Screening visit.
* Expected to require daily opioid medication throughout the course of the study.
* Willing to not use prohibited medications (including NSAIDs) throughout the duration of the study.
* Average Pain Score =5 at Screening for the index bone metastasis cancer pain site.
* Patient's Global Assessment of Cancer Pain of "fair", "poor" or "very poor" at Screening.
* Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1, or 2 at Screening.
* Adequate bone marrow, renal and liver function at Screening.
* International Normalized Ratio (INR) or prothrombin time (PT) <1.5 x ULN at Screening unless being treated with anticoagulant medication.
* Females must either be not of childbearing potential or, if of childbearing potential and at risk for pregnancy, must be willing to use at least one highly effective method of contraception throughout the study and for 112 days (16 weeks) after the last dose of assigned subcutaneous study medication.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pain related to an oncologic emergency.
* Brain metastasis or leptomeningeal metastasis.
* Presence of hypercalcemia at Screening.
* Pain primarily classified as not predominantly related to a bone metastasis.
* Systemic treatment for the primary malignancy or bone metastasis started within 30 days of the Baseline Assessment Period.
* Chemotherapies associated with peripheral neuropathy (ie, paclitaxel, docetaxel, oxaliplatin, cisplatin, vincristine, thalidomide or bortezomib) are prohibited during the study from 30 days prior to the first day of the Baseline Assessment Period to Week 48.
* Receipt of radiopharmaceutical treatment or radiotherapy for treatment of bone metastasis within 30 days of the Baseline Assessment Period.
* Concurrent adjuvant analgesics unless started at least 30 days prior to the start of the Baseline Assessment Period and maintained at a stable dose.
* Diagnosis of osteoarthritis of the knee or hip or findings consistent with osteoarthritis in the shoulder.
* History of significant trauma or surgery to a major joint within one year prior to Screening.
* History of osteonecrosis or osteoporotic fracture.
* X-ray evidence at Screening of: 1) rapidly progressive osteoarthritis, 2) atrophic or hypotrophic osteoarthritis, 3) subchondral insufficiency fracture, 4) spontaneous osteonecrosis of the knee (SPONK), 5) osteonecrosis, or 6) pathologic fracture.
* Signs and symptoms of clinically significant cardiac disease.
* Evidence of orthostatic hypotension at Screening or at Baseline prior to randomization.
* Diagnosis of a transient ischemic attack in the 6 months prior to Screening or diagnosis of stroke with significant residual deficits.
* History, diagnosis, or signs and symptoms of clinically significant neurological disease.
* Total impact score of >7 on the Survey of Autonomic Symptoms (SAS) at Screening.
* Past history of carpal tunnel syndrome (CTS) with signs or symptoms of CTS in the one year prior to Screening.
* History of significant alcohol, analgesic, or narcotic substance abuse within the six months prior to Screening.
* Planned surgical procedure during the duration of the study.
* Considered unfit for surgery or not willing to undergo joint replacement surgery if required.
* Known hypersensitivity to opioids or an underlying medical condition contraindicating opioid use.
* History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.
* Previous exposure to exogenous nerve growth factor or to an anti-nerve growth factor antibody.
* Presence of drugs of abuse, prescription medications without a valid prescription or other illegal drugs at Screening.
* Positive Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) tests at Screening indicative of current infection.
* Investigational site staff members and their family members, or Pfizer employees directly involved in the conduct of the trial.
* Participation in other studies involving investigational drug(s) within 30 days (or 90 days for investigational biologics) before Baseline Assessment Period and/or during study participation.
* Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential who are unwilling or unable to use one (1) highly effective method of contraception throughout the study and for 112 days after last dose of investigational product.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/06/2021
Sample size
Target
Accrual to date
Final
156
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [2] 0 0
Monash Medical Centre - East Bentleigh
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3165 - East Bentleigh
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Santa FE
Country [2] 0 0
Austria
State/province [2] 0 0
Krems
Country [3] 0 0
Austria
State/province [3] 0 0
Senftenberg
Country [4] 0 0
Brazil
State/province [4] 0 0
RIO Grande DO SUL
Country [5] 0 0
Brazil
State/province [5] 0 0
RJ
Country [6] 0 0
Brazil
State/province [6] 0 0
SAO Paulo
Country [7] 0 0
Brazil
State/province [7] 0 0
SC
Country [8] 0 0
Brazil
State/province [8] 0 0
SP
Country [9] 0 0
Brazil
State/province [9] 0 0
Sao Paulo
Country [10] 0 0
Chile
State/province [10] 0 0
Araucania
Country [11] 0 0
China
State/province [11] 0 0
Anhui
Country [12] 0 0
China
State/province [12] 0 0
Beijing
Country [13] 0 0
China
State/province [13] 0 0
Chongqing
Country [14] 0 0
China
State/province [14] 0 0
Heilongjiang
Country [15] 0 0
China
State/province [15] 0 0
Henan
Country [16] 0 0
China
State/province [16] 0 0
Hubei
Country [17] 0 0
China
State/province [17] 0 0
Shanghai
Country [18] 0 0
China
State/province [18] 0 0
Sichuan
Country [19] 0 0
China
State/province [19] 0 0
Zhejiang
Country [20] 0 0
China
State/province [20] 0 0
Tianjin
Country [21] 0 0
Czechia
State/province [21] 0 0
Plzen
Country [22] 0 0
Czechia
State/province [22] 0 0
Praha 2
Country [23] 0 0
Hungary
State/province [23] 0 0
Farkasgyepu
Country [24] 0 0
Hungary
State/province [24] 0 0
Miskolc
Country [25] 0 0
Hungary
State/province [25] 0 0
Nyiregyhaza
Country [26] 0 0
Hungary
State/province [26] 0 0
Szekesfehervar
Country [27] 0 0
Israel
State/province [27] 0 0
Afula
Country [28] 0 0
Israel
State/province [28] 0 0
Haifa
Country [29] 0 0
Israel
State/province [29] 0 0
Ramat Gan
Country [30] 0 0
Japan
State/province [30] 0 0
Aichi
Country [31] 0 0
Japan
State/province [31] 0 0
Chiba
Country [32] 0 0
Japan
State/province [32] 0 0
Gunma
Country [33] 0 0
Japan
State/province [33] 0 0
Hyogo
Country [34] 0 0
Japan
State/province [34] 0 0
Saga
Country [35] 0 0
Japan
State/province [35] 0 0
Tokyo
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Gyeonggi-do
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Daegu
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Seoul
Country [39] 0 0
Poland
State/province [39] 0 0
Bedzin
Country [40] 0 0
Poland
State/province [40] 0 0
Bialystok
Country [41] 0 0
Poland
State/province [41] 0 0
Czeladz
Country [42] 0 0
Poland
State/province [42] 0 0
Dabrowa Gornicza
Country [43] 0 0
Poland
State/province [43] 0 0
Gdansk
Country [44] 0 0
Poland
State/province [44] 0 0
Gliwice
Country [45] 0 0
Poland
State/province [45] 0 0
Grudziadz
Country [46] 0 0
Poland
State/province [46] 0 0
Katowice
Country [47] 0 0
Poland
State/province [47] 0 0
Lublin
Country [48] 0 0
Poland
State/province [48] 0 0
Poznan
Country [49] 0 0
Poland
State/province [49] 0 0
Warszawa
Country [50] 0 0
Romania
State/province [50] 0 0
Dolj
Country [51] 0 0
Romania
State/province [51] 0 0
Timis
Country [52] 0 0
Romania
State/province [52] 0 0
Bucuresti
Country [53] 0 0
Slovakia
State/province [53] 0 0
Bratislava
Country [54] 0 0
Slovakia
State/province [54] 0 0
Nove Zamky
Country [55] 0 0
Slovakia
State/province [55] 0 0
Pruske
Country [56] 0 0
Slovakia
State/province [56] 0 0
Zilina
Country [57] 0 0
Spain
State/province [57] 0 0
Alicante
Country [58] 0 0
Spain
State/province [58] 0 0
Islas Baleares
Country [59] 0 0
Spain
State/province [59] 0 0
Madrid
Country [60] 0 0
United Kingdom
State/province [60] 0 0
London
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Scotland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02609828