A Randomized, Open Label, Active Controlled Study of AMG 162 in Subjects with Advanced Cancer Currently Being Treated with Intravenous Bisphosphonates
- Conditions
- Bone metastases of solid tumors (except lung) or multiple myeloma bone disease
- Registration Number
- EUCTR2004-000511-25-BE
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 135
Treatment phase inclusion criteria:
-Patients =18 years of age with histologically confirmed solid tumor carcinomas
(except lung) or multiple myeloma
- Radiographic evidence (eg MRI, bone scan, CT scan, X-ray, etc) of 1 or more bone lesions. Radiographic evidence of diffuse osteopenia/ osteoporosis (evaluated by DXA scan or X-ray) is acceptable radiographic evidence for multiple myeloma bone disease.
- Currently receiving intravenous bisphosphonates for the treatment of bone metastases as defined in section 4.1.1.3 of protocol.
- Urinary NTx level > 50 nM BCE/mM creatinine in one measurement obtained within 4 weeks before study day 1
- ECOG score (0, 1, or 2)
- Adequate organ function (see section 4.1.1.6 of protocol for definition of criteria)
- Concurrent systemic anti-neoplastic therapy is allowed during study treatment.
There should be no planned change to subject’s anti-neoplastic regimen for 4 weeks prior to first administration of investigational product and for four weeks after first administration of investigational product.
- Before any study-specific procedure, the appropriate informed consent must be
obtained.
Extension Phase Inclusion Criteria:
-Completed the treatment phase and are currently enrolled in AMG 162 study 20040114
-For subjects randomized to the IV bisphosphonate arm during the treatment phase, urinary NTx level >50 nm BCE/mM creatinine in one measurement obtained within 4 weeks of enrollment into the extension phase
-ECOG score (0, 1, or 2)
-Adequate organ function as defined by criteria given in section 4.2.1.4 of protocol.
-Before any study-specific procedure, the appropriate informed consent for the extension phase must be obtained
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Treatment phase exclusion criteria:
-Unresolved toxicities > grade 2 from prior anti-cancer therapy (per investigator judgment), excluding alopecia
-More than two prior SREs
-Known brain metastases
-Prior history of or current evidence of osteonecrosis/ osteomyelitis of the jaw
-Active dental or jaw condition which requires oral surgery
-Non-healed dental/ oral surgery
-Planned invasive dental procedures for the course of the study
-Prior administration of OPG construct (i.e. AMGN-0007, Fc-OPG), or AMG 162
-Administration of calcitonin, parathyroid hormone related peptides, mithramycin, strontium ranelate, or gallium nitrate within 8 weeks prior to randomization
-Concomitant chronic systemic corticosteroid administration (> 5 mg/day of prednisone or equivalent), unless the corticosteroids are administered as part of antineoplastic treatment
-Evidence of impending fracture in weight bearing bones
-Radiation therapy to bone within 2 weeks before randomization.
-Autologous transplantation less than one year before randomization
-Prior allogeneic transplantation
-Evidence of any of the conditions per subject self report or medical chart review given under section 4.1.2.15 of the protocol.
-Any organic or psychiatric disorder, serum chemistry, or hematology, which in the opinion of the investigator may prevent the subject from completing the study or interfere with the interpretation of the study results
-Is currently enrolled in the active treatment phase of a study investigating an unapproved product or device, or has been treated within the last 30 days with an unapproved product or device (thalidomide use is allowed). Subjects in the observational phase of clinical studies (eg, to collect survival data) are allowed.
-Pregnancy or breastfeeding as described in section 4.1.2.18
-Known sensitivity to any of the products to be administered during dosing (i.e., bisphosphonates or mammalian derived products)
-Any kind of disorder that compromises subject’s ability to give written informed consent and/or to comply with study procedures
-Patients with urinary tract stents or catheters
Extension phase exclusion criteria:
-For subjects randomized to AMG 162 during the treatment phase only, greater than 25 weeks between last dose of investigational product (AMG 162) and enrollment into extension
-More than two prior SREs
-Known brain metastases
-Prior history of or current evidence of osteonecrosis/ osteomyelitis of the jaw
-Active dental or jaw condition which requires oral surgery
-Non-healed dental/ oral surgery
-Planned invasive dental procedures for the course of the study
-Administration of calcitonin, parathyroid hormone related peptides, mithramycin, strontium ranelate, or gallium nitrate within 8 weeks prior to randomization into the extension phase
-Concomitant chronic systemic corticosteroid administration (> 5 mg/day of prednisone or equivalent), unless the corticosteroids are administered as part of antineoplastic treatment
-Evidence of any of conditions per subject self report or medical chart review as listed under section 4.2.2.10 of the protocol
-Any organic or psychiatric disorder, serum chemistry, or hematology, which in the opinion of the investigator may prevent the subject from completing the study or interfere with the interpretation of the study results
-Is currently enrolled in the active treatment phase of a study investigating an unapproved product or device, or has been treated within the last 30
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method