[c09aa8]: / clusters / 9knumclustersv2 / clust_395.txt

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Patients may receive bisphosphonates or denosumab concurrently with study treatment; if started prior to registration, it must be started at least days prior to registration
Patients may be treated with bone modifying agents such as bisphosphonates or RANK-ligand agents (e.g. denosumab) per American Society of Clinical Oncology (ASCO) guidelines; whenever possible, patients requiring bone modifying agents should start treatment >= days prior to study therapy and should continue the same agent throughout study unless clinically compelled to change
Initiation of bisphosphonate/denosumab therapy during protocol treatment; patients on stable doses of bisphosphonates or denosumab which have been started no less than weeks prior to treatment start may continue on this medication; NOTE: initiation of bisphosphonate/denosumab therapy will be allowed for the treatment of osteoporosis or prevention of skeletal-related events (SRE) during protocol treatment
Denosumab or zoledronic acid are allowed
Is expected to require any other form of anti-cancer therapy while in the trial. Zoledronic acid or denosumab as supportive care for bone metastases will be allowed if started prior to study enrollment
Participants who are receiving or will receive other concurrent chemotherapies or immunotherapies for their cancer (except for patients who will receive letrozole, anastrozole, exemestane, tamoxifen, fulvestrant, trastuzumab, bisphosphonates, denosumab or ovarian suppression therapy)
Bone metastases with prior history of pathologic fracture, lytic lesions requiring an orthopedic intervention, or not receiving bisphosphonates or denosumab
Radiation therapy, chemotherapy, immunotherapy, investigational therapy or corticosteroid use within weeks of or after eligibility-defining bone marrow biopsy. Bisphosphonates and denosumab are permitted if subject has been receiving for at least days
Initiation of bisphosphonate/denosumab therapy during the study; subjects on stable doses of bisphosphonates or the tumor necrosis factor receptor superfamily member a, subfamily L (RANK-L) inhibitor, denosumab, which have been started no less than weeks prior to registration, may continue on this medication
Concurrent osteoclast-inhibitory therapies (zoledronic acid, denosumab) are permitted if patients have been on a stable dose for at least month
The use of raloxifene, denosumab, or bisphosphonates for bone health is allowed
Concurrent treatment with bisphosphonates or denosumab is required
Concurrent anti-cancer therapy other than the ones specified in the protocol is not permitted during study participation; bisphosphonates or denosumab are allowed
Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to denosumab are not eligible (i.e. same class of drugs) (Note: prior bisphosphonates are allowed; patients could have received bisphosphonates or be bisphosphonate-naive; patients who were previously on bisphosphonates can be enrolled in the study, as long as they have a wash-out period of weeks prior to registration)
Subject has started treatment with denosumab < month prior to study entry; subjects are allowed to be on bisphosphonates or denosumab provided they are on a stable dose for >= weeks before administration of study drug
Prior chemotherapy for castration resistant disease; chemotherapy given in the hormone-sensitive setting is permissible if stopped at least weeks prior to registration\r\n* Note: Patients can receive a stable dose of bisphosphonates for bone metastases, including zoledronic acid, or denosumab before and during the study as deemed appropriate by the treating physician
UROTHELIAL CARCINOMA EXPANSION COHORT: Bisphosphonates and denosumab are permitted if on a stable dose for >= weeks
If a subject is currently receiving bisphosphonates, the subject must have received the bisphosphonates for at least four weeks prior to the first dose of ARQ . a. Initiation of bisphosphonates during the study may be allowed provided the subject completes the first cycle of treatment without any dose limiting toxicity (DLT) and the Investigator rules out tumor progression.
Patients who are or are not receiving bisphosphonates or denosumab are eligible; bisphosphonates or denosumab should not be initiated after registration and during active treatment
If a subject is currently receiving bisphosphonates or denosumab, the subject must have received the bisphosphonates or denosumab for at least four weeks before starting study treatment. (Initiation of bisphosphonates or denosumab during the study may be allowed provided the subject completes the first cycle of treatment without any DLT and the Investigator rules out tumor progression.)
Patients on bisphosphonates, denosumab, and/or endocrine therapy are eligible
Bisphosphonates are allowed, at the treating investigators discretion
Bisphosphonates, hormone modification therapy, and trastuzumab are permitted without restriction
Concomitant use of bisphosphonates is allowed
Bisphosphonates and/or denosumab are allowed
Patients receiving bone loss prevention treatment with bone-modifying agents (e.g. denosumab, zoledronic acid) must be on stable doses for at least weeks prior to randomization
Treatment with bisphosphonates or denosumab is allowed and recommended per the standard of care
Any anticancer therapy including; small molecules, immunotherapy, chemotherapy monoclonal antibodies or any other experimental drug within five half-lives but maximum four weeks before first infusion. Accepted exceptions are bisphosphonates, denosumab and gonadotropin-releasing hormone agonist or antagonist.
Prior administration of denosumab
Clinically significant hypersensitivity to denosumab or any components of denosumab mg
The subject has started treatment with drugs used to control loss of bone mass (eg, bisphosphonates or denosumab) within weeks prior to the first dose of study treatment
Current treatment or treatment within weeks of screening with bisphosphonates.
Concurrent use of bisphosphonates is not permitted; however, prior bisphosphonates or once-a-year intravenous bisphosphonate given for the treatment of osteoporosis is permitted
Subject that started a bone modifying agent (e.g. bisphosphonates, denosumab) ? days of study drug initiation (note: ongoing bone modifying agents administered > days are allowed).
Subjects with bone metastases should be treated with intravenous bisphosphonates or subcutaneous denosumab (or investigator preferred standard of care) prior to and/or during the trial, unless there is a contraindication or subject intolerance to these therapies. For patients who are normocalcemic, therapy can be initiated at the time the patient initiates study drug
Subject received bisphosphonates or denosumab within weeks prior to day unless administered at stable dose or to treat diagnosed osteoporosis
Oral examination and appropriate preventive dentistry will be performed prior to the initiation of denosumab therapy.
Prior treatment for breast cancer with endocrine therapy (adjuvant or metastatic settings) is allowed but should be discontinued at randomization. Patients treated with bisphosphonates at entry or who start bisphosphonates during study may continue this therapy during protocol treatment.
Patients who have previously received denosumab
Patients receiving bisphosphonates
Initiation of new treatment with denosumab, bisphosphonates, or systemic corticosteroids for treatment of prostate cancer within weeks before enrollment;
Plans to begin bisphosphonates or denosumab after registration or began therapy regiment =< days from registration\r\n* NOTE: patients on a stable dose of bisphosphonates or denosumab > days prior to registration are acceptable
Patients currently receiving bone loss prevention treatment (e.g. bisphosphonates, denosumab, etc.) must be on a stable dose for at least weeks prior to starting study treatment
Participants receiving bisphosphonates therapy or denosumab can be maintained on this therapy; if participants have not started bisphosphonates, it is recommended that they start treatment after the first (optional) biopsy
Patients must be on a stable concomitant medication regimen, defined as no changes in medication or in dose within weeks prior to start of olaparib dosing, except for bisphosphonates, denosumab and corticosteroids, which should be stable for at least weeks prior to start of olaparib dosing.
Participants receiving bisphosphonates therapy or denosumab can be maintained on this therapy; if participants have not started bisphosphonates or denosumab, it is recommended that they start treatment after the first biopsy
Participants may not be receiving any other investigational agents; concurrent treatment with bisphosphonates or denosumab is allowed
Concomitant therapy with bisphosphonates is allowed
Patients on stable doses of bisphosphonates or denosumab which have been started prior to registration may continue on this medication, patients who are not on bisphosphonates or denosumab are eligible as long as they initiate therapy prior to registration
Concomitant use of bisphosphonates is allowed
For patients receiving bone-loss prevention treatment (e.g., bisphosphonates or denosumab), the patient must be on stable dose ? weeks prior to start of study drug.
Patients may or may not have started bisphosphonates
Subjects with bone metastases should be treated with intravenous bisphosphonates or subcutaneous denosumab (or investigator preferred standard of care) prior to and during the trial, unless there is a contraindication or subject intolerance to these therapies
Prior administration of denosumab
Bisphosphonates and denosumab are permitted, if on a stable dose for >= weeks
Patient may receive bisphosphonates/denosumab for the palliation of bone metastases
Bone-directed therapy (e.g., bisphosphonates or denosumab) is permitted.
Prior and ongoing zoledronic acid or denosumab therapy is allowed
Patients who have not discontinued all prior medical therapy for breast cancer (with the exception of bisphosphonates or denosumab) at least days prior to first dose of orteronel; this includes patients who have received other investigational agents within days prior to the first dose of orteronel
Concurrent treatment with bisphosphonates is permitted, however treatment must be initiated prior to the first dose of study therapy;
Prior and/or planned concomitant medical therapy during the study period (through day post-HCT) with other bisphosphonates, denosumab, or teriparatide
Participants on bisphosphonates/denosumab may continue receiving bisphosphonate therapy during study treatment
Be diagnosed with bone metastases subsequent to breast (female subjects only) or prostate carcinoma, and will have received zoledronate or denosumab therapy for at least months at the time of enrollment
Prior administration of denosumab
Patients must be at least days post cytotoxic chemotherapy, radiotherapy, monoclonal antibody and/or other biologic therapy, prior to enrollment; patients on bisphosphonates, denosumab, and/or endocrine therapy and may continue throughout duration of study
Subjects must be on therapy with bisphosphonates or denosumab for at least month before start of study treatment.
Patients on stable doses of bisphosphonates or the receptor activator of RANK-L inhibitor, denosumab, which have been started no less than weeks prior to treatment start, may continue on this medication, however patients are not allowed to initiate bisphosphonate/denosumab therapy during the study
Current or prior use of bone active medication (bisphosphonates, teriparatide, selective estrogen receptor modulators, or denosumab)
Current treatment with bisphosphonates (as of time of enrollment)