[c09aa8]: / clusters / 9knumclustersv2 / clust_2859.txt

Download this file

111 lines (110 with data), 19.5 kB

  1
  2
  3
  4
  5
  6
  7
  8
  9
 10
 11
 12
 13
 14
 15
 16
 17
 18
 19
 20
 21
 22
 23
 24
 25
 26
 27
 28
 29
 30
 31
 32
 33
 34
 35
 36
 37
 38
 39
 40
 41
 42
 43
 44
 45
 46
 47
 48
 49
 50
 51
 52
 53
 54
 55
 56
 57
 58
 59
 60
 61
 62
 63
 64
 65
 66
 67
 68
 69
 70
 71
 72
 73
 74
 75
 76
 77
 78
 79
 80
 81
 82
 83
 84
 85
 86
 87
 88
 89
 90
 91
 92
 93
 94
 95
 96
 97
 98
 99
100
101
102
103
104
105
106
107
108
109
110
Patients must not currently be receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYPA (at least week prior); all patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYPA
Patients taking additional dietary/herbal supplements (excluding Senekot) outside of this protocol and refusing to stop are not eligible
Intake of any herbal preparations or medications (including, but not limited to, Saint Johns wort and ginkgo biloba) and dietary supplements within days prior to first dose of study drug
Inability to comply with dietary restrictions for foods, supplements, and medications with potential for adverse interactions with phenelzine or to otherwise cooperate fully with the investigator and study personnel
Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
Concurrent treatment (or inability to stop therapy) with medications or herbal supplements known to be potent inducers of CYPA
Herbal preparations/medications are not allowed throughout the study
Patients with concomitant use of drugs, herbal supplements and/or ingestion of foods known to modulate cytochrome P family subfamily A member (CYPA) enzyme activity as specified in the drug specific appendix
Patients who are unwilling to stop the use of herbal remedies while receiving study treatment
Concomitant use of the following drugs: antioxidants; herbal or other alternative therapy medications; vitamin supplements (especially vitamins A, C, and E) other than a standard dose multivitamin, acetaminophen, cyclosporine A or analogue; verapamil; tamoxifen or analogue, ketoconazole, chlorpromazine; RU; indomethacin; or sulfinpyrazone, tetracycline, nalidixic acid, nitrofurantoin, phenytoin, sulfonamides, lithium, ceftriaxone, and amiodarone; if the patients discontinue usage of the above drugs, they can be eligible for enrollment into the study after a washout period of four half-lives
Currently receiving any prohibited medications including vitamins and herbal supplements
Has received any of the following in the weeks prior to randomization: -alpha-reductase inhibitors, herbal medications, natural hormonally active foods (e.g., phytoestrogens) or other food supplements known to alter PSA in humans
Currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYPA (at least weeks prior)
STRATUM A: Participants must discontinue herbal preparations, herbal medication, and dietary supplements, with the exception of multivitamins, at least days prior to study enrollment
STRATUM B: Participants must discontinue herbal preparations, herbal medication, and dietary supplements, with the exception of multivitamins, at least days prior to study enrollment
STRATUM C: Participants must discontinue herbal preparations, herbal medication, and dietary supplements, with the exception of multivitamins, at least days prior to study enrollment
Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYPA (at least week prior). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYPA
Current use of natural herbal products or other folk remedies; if using previously, patients must stop using natural herbal products while participating in this study; multivitamin, calcium (Ca)/vitamin D (Vit D) and other vitamin complex supplements are allowed
Use of alternative medications (e.g., herbal or botanical that could interfere with clofarabine) is not permitted during the entire study period
Concomitant use of herbal medications at least days prior to the first dose of study drug and throughout participation in the trial.
Taking any medications or herbal supplements that are known to be strong inhibitors of CYPA within at least days before the first dose of ponatinib in patients with newly diagnosed only.
Taking any medications or herbal supplements that are known to be strong inhibitors of CYPA within at least days before the first dose of ponatinib.
Use of herbal supplements unless discontinued >= days prior to initiation of study drug
Currently receiving treatment, including medications and herbal preparations with known strong inducers or inhibitors of cytochrome p enzymes cytochrome P family , subfamily A, polypeptide / (CYPA/) medications that have a narrow therapeutic window and are predominately metabolized through CYPA/ or herbal preparations/medications, dietary supplements, which cannot be discontinued at least one week prior to receiving investigational drug; anti-retrovirals, anti-microbials, and anti-arrhythmics are the most common medications that interact with these enzymes
Current use of natural herbal products or other complementary alternative medications (CAM) or folk remedies
PART GROUP EXCLUSION CRITERIA: Subjects who are currently receiving treatment with drugs or herbal medications that can impact drug metabolism
PART GROUP A EXCLUSION CRITERIA: Subjects who are currently receiving treatment with drugs or herbal medications that can impact drug metabolism
PART GROUP EXCLUSION CRITERIA: Subjects who are currently receiving treatment with drugs or herbal medications that can impact drug metabolism
All outside study medications and supplements will be reviewed and monitored by the inpatient pharmacy team; patients will be discouraged from taking herbals and additional supplements
Use of medications or supplements that are known to affect PSA within days prior to informed consent, including toremifene citrate, finasteride, testosterone, dehydroepiandrosterone (DHEA) or other testosterone-like supplements; no dutasteride within days prior to informed consent
Willing to stop herbal medications as directed by physician
Patients who are taking any herbal (alternative) medicines are NOT eligible for participation; patients must be off any such medications by the time of registration for at least weeks; NOTE: Vitamin supplements are acceptable
Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome P (CYP) A
Patients may not use any complementary or alternative medicines including natural herbal products or folk remedies
Use of herbal medications
Patients may not be receiving any other investigational agents; use of over-the-counter herbal medications will also be excluded
While participating, subjects must agree not to use soy supplements, over the counter estrogen supplements like Estroven, Chinese herbs, or other over-the-counter (OTC) herbal products
Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYPA (at least week prior); all patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYPA
Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
Herbal, alternative remedies, and alcohol containing over-the-counter mouthwashes are excluded during the course of the study
Patients who are taking and cannot discontinue over-the-counter (OTC) medications and nutritional supplements, including herbal or \Chinese\ medications, are not eligible, except if using the following OTC medications that are allowed at labeled doses, acetaminophen, aspirin, diphenhydramine, calcium carbonate antacids, branded multiple vitamin supplements and pseudoephedrine; topical preparations and decongestant nasal sprays are allowed
Unable or unwilling to stop the use of herbal supplements; the use of marijuana or its derivatives is allowed; the use of nutritional supplements may be allowed after review by a study pharmacist to confirm no significant risk of interaction with eribulin or radiation
Patients may not use herbal or non-traditional medications while receiving AMG therapy; all herbal medicines (e.g., St. Johns wort), vitamins, and supplements consumed by the subject within the days prior to receiving the first dose of AMG should be reviewed by the principal investigator
Patients who are taking any herbal (alternative) medicines are NOT eligible for participation; patients must be off any such medications by the time of registration for >= days\r\n* NOTE: Vitamin supplements are acceptable
Patients may not use any complementary or alternative medicines including natural herbal products or folk remedies
Concurrent use of herbal supplements and other non-traditional medications; all herbal supplements and other non-traditional medications must be stopped before time of registration
Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYPA (at least weeks prior); all patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects of CYPA
Currently receiving any prohibited medications including vitamins and herbal supplements
Herbal preparations/medications, dietary supplements.
Herbal preparations/ medications
Herbal preparations/medications, dietary supplements.
The use of dietary supplements or herbal medications within days of starting study therapy
Patients previously treated with herbal supplements, or other potential or experimental therapies for prostate cancer (apart from LHRH agonists and antiandrogens), must have been discontinued these treatments and completed at least a one-month washout prior to first vaccination
Patients currently receiving (or unable to stop use at least week prior to receiving the first dose of AZD/AZD) medications or herbal supplements known to be potent inhibitors or inducers of cytochrome P A/ and potential inhibitors of cytochrome P C (for patients to be enrolled into AZD cohorts only).
Not currently be taking tomato carotenoid dietary supplements or alternative products (e.g., lycopene supplements, Lyc-O-Mato, saw palmetto); vitamin A and beta-carotene supplements are allowed
Agree to consume a standardized vitamin and mineral supplement and avoid other nutrition, dietary, or alternative medications/supplements for the duration of the study
Participants must agree not to use natural herbal products or other folk remedies while participating in this study
Patients who are taking any herbal (alternative) medicines are NOT eligible for participation; patients must be off such medications by the time of registration
Patient is currently using herbal preparations or medications; participants should stop using herbal medications days prior to the first dose of the study drug
Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome P (CYP) A.
Use of herbal or alternative remedies that may affect hormonal status such as prostasol or PC-SPES
Participants may not use natural herbal products or remedies not approved by the Food and Drug Administration (FDA) while participating in this study
Herbal preparations/medications
Unwillingness to stop taking herbal supplements while on study
Initiation of strong antioxidant supplements during treatment, or ongoing use of supplements containing concentrated plant-derived polyphenols (pine bark, grape seed, green tea, milk thistle extracts; resveratrol; ellagic acid)
Patients who are taking any herbal (alternative) medicines are NOT eligible for participation; patients must be off any such medications by the time of registration; NOTE: Vitamin supplements are acceptable
Therapy with supplements or complementary is excluded with the following exceptions; all other supplements must be discontinued prior to initiation of study drug\r\n* Conventional multivitamin supplements\r\n* Selenium\r\n* Lycopene\r\n* Soy supplements
Use of supplements or complementary medicines/botanicals, except for conventional multivitamin supplements, calcium, selenium and soy supplements.
Patients who are unwilling to stop the use of herbal remedies while on the treatment phase of the study
Patients previously treated with herbal supplements, or other potential or experimental therapies for prostate cancer must have discontinued these treatments and completed at least a one-month washout prior to beginning treatment
Intake of any herbal preparations or medications (e.g., including, but not limited to, Saint-Johns wort and ginkgo biloba) and dietary supplements within days prior to first dose of study drug
Patients may not use natural herbal products or other folk remedies while participating in this study
Concurrent administration of herbal preparations.
Herbal preparations or over-the-counter supplements containing herbal ingredients (St. Johns wort, Estroven, blue cohosh) are prohibited during treatment and must be stopped within hours (h) of first dose of dasatinib
Willing to refrain from drinking any kind of tea (including herbal tea) or using supplements containing green tea for the duration of the study
Patient is currently using herbal preparations or medications. Patient should stop using herbal medications days prior to the first dose of the study drug.
Patients must discontinue all herbal supplements at a minimum of one week prior to initiation of therapy (such information will be collected on each patient)
Use of medications or herbal supplements which are known to potentially lower serum PSA within weeks of day of protocol therapy
Herbal supplements are prohibited week prior to the planned first study drug administration, during the clinical study, and up to the time that the patient is discharged from the study
Patients receiving herbal preparations/medications
The subject is unable or unwilling to stop taking vitamins, herbal remedy, or nonprescription medications
Patients who are receiving other biologic therapies including cytokines or growth factors not specified by the protocol; herbal supplements will not result in exclusion but should be noted and reviewed with the Principal Investigator (PI)
Patients who are receiving other biologic therapies including cytokines or growth factors not specified by the protocol; herbal supplements will not result in exclusion but should be noted and reviewed with the PI
Taking any medications or herbal supplements that are known to be strong inhibitors of CYPA within at least days before the first dose of ponatinib
Patients who have taken -alpha-reductase inhibitors (finasteride or dutasteride), saw palmetto, or PC-SPES within the last weeks are ineligible for this study; patients taking other herbal supplements, vitamins, or other alternative medications are eligible for this study, as long as they were started > months prior to study entry, have remained on a stable regimen, and will remain on a stable regimen for the duration of participation on this study
Patient using herbal and dietary supplements that may interact with CYPA
Patients currently taking IMPACT or other immunonutrition products (arginine-containing supplements) will be excluded; other forms of nutritional supplementation, such as caloric supplementation, tube feeding, or other dietary supplements are allowed on study
Daily use of n- PUFA concentrates or capsules or any other supplements that might interact with n- PUFA supplements if > mg per day of eicosapentaenoic acid (EPA)/ docosahexaenoic acid (DHA) within six months of study initiation
Consumption of dietary supplements or medications such as steroids that could affect metabolism
Subjects currently using N-acetylcysteine, alpha-lipoic acid supplements, or dry whey protein supplements
On stable doses of any supplements or medications for six weeks prior to enrollment on the study
Planning on starting or stopping any chronic supplements or medications within six weeks prior to or throughout the study period
Use of any over the counter herbal/dietary supplement marketed for fatigue or energy (for example, products containing any type of ginseng, Rhodiola rosea, high doses of caffeine, guarana, or anything called an adaptogen)
Chronic use of any herbal or dietary supplement containing apigenin within the months prior to entry on the study
Use of over the counter steroid hormonal supplements
Use of n- fatty acids or high dose antioxidant supplements other than what is provided in the trial
Current use of commercial or natural/herbal weight loss supplements
Patients concurrently taking the following drugs are excluded: antioxidants, herbal or other alternative therapy medications, vitamin supplements (especially vitamins A, C, and E) other than at standard multivitamin doses, cyclosporine A or analogue; verapamil; tamoxifen or analogue, ketoconazole, chlorpromazine; RU; indomethacin; or sulfinpyrazone, tetracycline, nalidixic acid, nitrofurantoin, phenytoin, sulfonamides, lithium, and amiodarone. If the patients discontinue usage of the above drugs, they can be eligible for enrollment into the study (screening visit) one week or -half lives of the drug in question, whichever is the longer, after the discontinuation. For patients requiring any of these medications, entry is permissible only with permission from the medical monitor.
Concurrent use of other alternative medicines such as herbal agents and high dose vitamins
Concurrent use of other alternative medicines such as herbal agents and high dose vitamins and minerals
Any of the following current (=< last weeks) or planned therapies: antineoplastic chemotherapy, androgens, estrogens, progestational agents, other herbal supplements, including soy (herbal teas from a store are allowed), or Warfarin ( mg of daily warfarin is allowed for central line patency)
Patients who are taking any pills containing herbal (alternative) medicines are NOT eligible for participation; patients must be off any such medications by the time of registration
Agree to consume a standardized vitamin/mineral supplement and avoid other nutrition, dietary or alternative medications/supplements for the duration of the study
Chronic use of omega- fatty acid concentrates or capsules within the months prior to entry on the study or any other supplements that might interact with omega- fatty acid supplements
Chronic use of any herbal or dietary supplement containing curcumin or curcuminoids within the months prior to entry on the study or any other supplements that might interact with NEC
Certain medicines and herbal remedies taken during the days before the start of study drug
Subjects taking calcium supplements; if subjects are willing to discontinue these supplements, there must be a -month wash out period before enrollment
Use, in the months prior to week visit, of antibiotics, hormone replacement therapy, nonprescription hormones or herbal supplements for menopausal symptoms, or flaxseed supplements
Has history or current use of over-the-counter medications, dietary supplements, or drugs outside protocol-specified parameters
Concomitant systemic use of anticancer herbal medications. These should be stopped prior to study entry.