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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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7 January 2013 |
Main ID: |
EUCTR2008-005181-31-AT |
Date of registration:
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03/11/2010 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER EFFICACY AND SAFETY STUDY OF TANEZUMAB AS ADD-ON THERAPY TO OPIOID MEDICATION IN PATIENTS WITH PAIN DUE TO BONE METASTASES
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Scientific title:
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PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER EFFICACY AND SAFETY STUDY OF TANEZUMAB AS ADD-ON THERAPY TO OPIOID MEDICATION IN PATIENTS WITH PAIN DUE TO BONE METASTASES |
Date of first enrolment:
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25/11/2010 |
Target sample size:
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58 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005181-31 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Austria
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France
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Hungary
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Latvia
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. The patient must have prostate cancer, breast cancer, renal cell cancer or multiple myeloma that has been diagnosed as having metastasized to bone, and must have moderate to severe pain secondary to the bone metastasis. Radiographic confirmation of bone metastasis (via bone scan, MRI, CT scan or plain x-ray with corresponding bone scan) within 30 days prior to Screening Visit is required. Bone scan confirmation of the bone metastasis is required at Screening Visit if radiographic confirmation of bone metastasis within 30 days prior to screening is lacking. If bone scan at Screening Visit is not clearly consistent with bone metastasis, additional radiographic confirmation (eg, with MRI, CT scan or plain x-ray) is required prior to randomization. 2. The patient is expected to require daily opioid medication throughout the course of the study. 3. The patient is =18 years of age. 4. The patient’s weight is =45 kg. 5. Female patients must meet one of the following criteria: a. Female patients of non-childbearing potential: must be postmenopausal, defined as amenorrheic for at least 1 year AND have a serum follicle-stimulating hormone (FSH) level greater than 30 IU/L at Screening; or must be surgically sterile, defined as having had a hysterectomy and/or bilateral oophorectomy; b. Female patients of child-bearing potential: must not be pregnant or lactating and must be abstinent or use adequate contraception (2 forms of birth control, one of which must be a barrier method). c. Female patients of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline prior to study medication dosing. d. Females of child-bearing potential and males must be willing to use approved methods of contraception from commencement of screening procedures until 16 weeks after the dose of study medication. 6. Male patients must also agree that they and their female spouses / partners will use adequate contraception (2 forms of birth control, one of which must be barrier method) or be of non-childbearing potential (ie, is post-menopausal or surgically sterile). Females of child-bearing potential and males must be willing to use approved methods of contraception from commencement of screening procedures until 16 weeks after the dose of study medication. 7. The patient has a Karnofsky Performance Score =?50% at Screening Visit. 8. The patient has an anticipated life expectancy of =?6 months at Screening Visit. 9. The patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. 10. The patient has provided written informed consent prior to admission to this study. 4.2. Inclusion Criteria (Randomization) Prior to randomization, the following criteria for pain, daily opioid use, and adverse events must be met during the 3 day Baseline Assessment Period: 1. Total daily dose (fixed component + rescue doses) of the opioid regimen has not changed by more than +20% from Day 1 to Day 2 and from Day 1 to Day 3 of the Baseline Assessment Period. 2. There have been =3 IR rescue episodes per day from Day 1 to Day 3 of the baseline Assessment Period for breakthrough pain. 3. The mean value of the “average pain intensity over the last 24 hours” scores from Day 1 to Day 3 of the Baseline Assessment Period must be =4 on an 11-point NRS scores range from 0-10). 4. There are no intolerable side effects in the judgment of the patient from Day 1 to day 3
Exclusion criteria: Patients presenting with any of the following will not be randomized into the study: ? The patient’s pain is related to an oncologic emergency such as bowel obstruction/perforation, brain metastases, epidural metastases, leptomeningeal metastases, fracture or impending fracture of weight-bearing bone or pain related to infection. ? The patient’s pain is primarily classified as neuropathic or unknown in nature, has resulted from prior cancer therapy, or is not related to a bone metastasis. ? The patient has received any investigational agent (ie, a medication not approved by the FDA) within 30 days prior to randomization or is scheduled to receive an investigational drug other than tanezumab during the course of this study. ? The patient is about to begin or has begun systemic therapy for the primary malignancy (eg, chemotherapy) within 2 weeks of randomization, or for a bone metastasis (eg, bisphosphonates) within 4 weeks of randomization. ? The patient is currently on a regimen of ongoing therapy for the primary malignancy (eg, chemotherapy) which begun more than 2 weeks before randomization, or for a bone metastasis (eg, bisphosphonates), which began more than 4 weeks before randomization and is anticipated to change (including additions to or changes in chemotherapy regimen) during the treatment period, unless the investigator determines the therapy is unlikely to improve pain. Completion of non-changing, ongoing therapy begun more than 4 weeks before randomization is allowed. ? The patient is expected to use any prohibited analgesic specified in the protocol, or to receive any active anticancer therapy throughout the pretreatment and treatment periods that is likely to confound assessment of analgesic efficacy or safety. ? Receipt of radiopharmaceutical treatment or radiotherapy for treatment of bone metastasis within 4 weeks of randomization. ? Planned surgical procedure during the duration of the study. ? The patient uses concurrent adjuvant analgesics such as non-steroidal anti-inflammatory drugs (NSAIDs, including selective Cox-2 inhibitors), SNRIs, tricyclic antidepressants, anticonvulsant medication, corticosteroids, or muscle relaxants unless these drugs were started more than 30 days prior to randomization and unless they are maintained at a stable dose. ? Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =3.0 times the upper limit of normal, or creatinine exceeding 1.7 mg/dL (150 µmol/L) in men or 1.5 mg/dL (133 µmol/L) in women at Screening Visit 1 (each confirmed by a repeat test) or any other laboratory abnormality that in the opinion of the investigator would contraindicate study participation. ? Presence of hypercalcemia at Screening (Visit 1), defined as albumin-corrected serum calcium concentration of =12 mg/dL. If measured albumin is <4.5 gm/dL, corrected calcium (mg/dL) = measured calcium (mg/dL) + 0.8 x (4.5 gm/dl-measured albumin in gm/dl). ? Known history of: a. Rheumatoid arthritis; b. Seronegative spondyloarthropathy (eg, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory bowel disease-related arthropathy); c. Primary avascular necrosis of the bone in any location. Necrosis of the bone secondary to radiotherapy (ie, osteoradionecrosis) and in relation to metastatic disease of the bone (ie, involving the tumour-bone interface) is allowable. ? History of significant trauma to a major joint within one year prior to Screening; ? Known history or evidence of osteoarthrit
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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PAIN DUE TO BONE METASTASES MedDRA version: 13.1
Level: LLT
Classification code 10049038
Term: Metastatic bone pain
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Intervention(s)
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Product Name: Tanezumab Product Code: PF-04383119 Pharmaceutical Form: Solution for injection INN or Proposed INN: Tanezumab Current Sponsor code: PF-04383119 Other descriptive name: RN624, RI624 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Primary end point(s): The primary efficacy endpoint is the change from Baseline to Week 6 in the daily average pain intensity measured by the 11-point Pain Intensity Numerical Rating Scale (NRS) where scores range from 0-10. Baseline is defined as the average daily Pain NRS score during the Stabilization Phase prior to Randomization (expected to be 3 days).
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Main Objective: The primary objective of this study is to evaluate the analgesic efficacy of single dose tanezumab 10 mg in combination with opioids (tanezumab 10 mg + opioids compared with opioids alone (placebo + opioids) in cancer patients with chronic pain due to bone metastases.
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Secondary Objective: • To characterize the time course of analgesia associated with tanezumab 10 mg when administered in combination with opioids (tanezumab + opioids) compared with opioids alone (placebo + opioids).
• To evaluate opioid consumption, rescue medication use and Opioid-Related Symptom Distress Scale scores of a single dose of tanezumab 10 mg in combination with opioids (tanezumab 10 mg + opioids) compared with opioids alone (placebo + opioids).
• To examine the global assessment scores and the effect on patient function of a single dose of tanezumab 10 mg in combination with opioids (tanezumab 10 mg + pioids) compared with opioids alone (placebo + opioids).
• To characterize tanezumab pharmacokinetics in cancer patients with chronic pain due to bone metastases and treated with opioids.
• To assess the safety and tolerability of single dose tanezumab 10 mg IV in patients with chronic pain due to bone metastases and treated with opioids.
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Secondary ID(s)
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2008-005181-31-HU
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A4091003
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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