A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone
- Conditions
- -C795 Secondary malignant neoplasm of bone and bone marrowSecondary malignant neoplasm of bone and bone marrowC795
- Registration Number
- PER-020-09
- Lead Sponsor
- PFIZER S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• The patient must have a prostate or breast cancer that has been diagnosed as having a bone metastasis, and must have moderate to severe pain as a result of bone metastasis. Radiographic confirmation of bone metastasis is required (by bone scan. MRI, CT or common x-rays with the corresponding bone scan) within 30 days before the Selection Visit, Confirmation of bone scan of bone metastasis is required in the Selection Visit if there is no radiographic confirmation of bone metastasis within 30 days before the selection. If the bone scan at the Selection Visit is not clearly consistent with bone metastasis, additional radiographic confirmation (for example, MRI, CT or common x-rays) is required before randomization.
• The patient is expected to require opioid drugs daily throughout the course of the study.
• The patient is> 18 years old.
• The patient weighs> 45 kg.
• Female patients must meet one of the following criteria: a. Female patients without reproductive potential: they must be postmenopausal, defined as amenorrheic for at least 1 year and have a serum follicle stimulating hormone (FSH) level greater than 30 lU / L in the Selection; or must have been surgically sterilized, defined as having undergone a hysterectomy and / or bilateral oophorectomy, b. Potentially fertile female patients: should not be pregnant or breastfeeding and should remain abstinent or use an appropriate contraceptive (2 contraceptive methods, one of which must be a barrier method). c. Potentially fertile female patients should have a negative serum pregnancy test at the National Team and a negative urine pregnancy test at the Baseline before administering the study drug. d. Potentially fertile women and men should be willing to use approved contraceptive methods from the start of screening procedures until 16 weeks after the dose of the study drug.
• Male patients must also accept that their female wives / partners will use appropriate contraceptive methods (2 contraceptive methods, one of which must be a barrier) or not be potentially fertile (ie, postmenopausal or surgically sterilized). Potentially fertile women and men should be willing to use approved contraceptive methods from the start of screening procedures until 16 weeks after the dose of the study drug.
• The patient has a Karnofsky Performance Score> 50% in the Selection Visit (See Annex 4).
• The patient has an expected life expectancy of 6 months at the Selection Visit,
• The patient must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
• The patient has provided written informed consent before admission to this study.
• The patient´s pain is related to an oncological emergency such as intestinal obstruction / perforation, cerebral metastasis, epidural metastasis, leptomeningeal metastasis, fracture or fracture that causes impediments in a bone that supports weight or pain related to the infection.
• The patient´s pain is mainly classified as neuropathic or of an unknown nature, has resulted from prior cancer therapy and is not related to bone metastasis.
• The patient has received a research agent (ie, drug not approved by the FDA) within 30 days prior to randomization or is scheduled to receive a Research drug other than tanezumab during the course of this study.
• The patient is about to begin or has started a systemic therapy for primary malignancy (for example, chemotherapy) or for bone metastases (for example, bisphosphonates) within 4 weeks of randomization.
• The patient is currently on an ongoing therapy regimen for primary malignancy (for example chemotherapy) or for bone metastases (for example, bisphosphonates) that has started more than 4 weeks before randomization and is expected to change (including additions to or changes in the chemotherapy regimen) during the treatment period, unless the investigator determines that the therapy is unlikely to improve pain. The culmination of the therapy is allowed without change initiated more than 4 weeks before randomization.
• The patient is expected to use any of the prohibited analgesics specified in the protocol or receive any active anticancer therapy throughout the pre-treatment and treatment periods that is likely to confuse the evaluation of the efficacy or safety of the analgesic.
• Receipt of radiopharmaceutical or radiotherapy treatment for the treatment of bone metastases within 4 weeks of randomization,
• Surgery procedure planned during the course of the study.
• The patient uses concurrent adjuvant analgesics such as nonsteroidal anti-inflammatory drugs (NSAIDs, including selective Cox-2 inhibitors), SNRIs, tricyclic antidepressants, anticonvulsant drugs, corticosteroids or muscle relaxants unless these drugs are started more than 30 days before randomization and unless kept at a stable dose.
• The patient has a history of significant abuse of alcohol, analgesics or narcotic substances within six months prior to selection.
• Prior exposure to nerve growth factor or to an antinervious growth factor antibody.
• The patient has a history of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG fusion protein.
• The patient has known hypersensitivity to opioids or an underlying medical condition that contraindicates the use of opioids.
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)> 3.0 times the normal upper limit or creatinine greater than 1.7 mg / dL (150 pmol / L) in men or 1.5 mg / dL (133 pmol / L) in women in the Selection Visit 1 (each confirmed by a repeated test) or any other laboratory abnormality that in the opinion of the researcher would contraindicate participation in the study.
• Presence of hypercalcemia in the Selection (Visit 1), defined as a corrected serum calcium concentration for albumin of al2 mg / dL. If the measured albumin is <4.5 gm / dL, corrected calcium (mg / dL) = measured calcium (mg / dL) + 0.8 X (4.5 gm / dl-albumin measured in gm / dl).
• Presence of drug abuse (except for opioids, which are allowed) in the detection of the drug
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:measured by the 11 point Pain Intensity Numerical Rating Scale (NRS; 0-10). Baseline is the average daily Pain NRS score during Stabilization Phase prior to Randomization (3 days).<br>Measure:Change from Baseline to Week 6 in daily average pain intensity<br>Timepoints:16 weeks<br>
- Secondary Outcome Measures
Name Time Method