History of hypersensitivity to ribociclib or compounds of similar chemical or biologic composition to ribociclib or other drugs formulated with polysorbate 80; or enzalutamide; all herbal, alternative and food supplements (i.e., prostate cancer [PC]-Spes, saw palmetto, St John wort, etc.); they must be discontinued prior to treatment start; patients may continue on a daily multi-vitamin, calcium and vitamin D
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 John’s wort and ginkgo biloba) and dietary supplements within 7 days prior to first dose of study drug
Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart), or any herbal product known to decrease PSA levels (e.g., saw palmetto and PC-SPES), or any systemic corticosteroid within 2 weeks prior to first dose of study drug; if the medication has a known half life such that 5 half lives is less < 2 weeks, this 5 half-life wash out is acceptable
Herbal preparations/medications are not allowed throughout the study
Concurrent use of herbal preparations including saw palmetto
Subject is unwilling to stop using herbal supplements that can affect the PSA, such as saw palmetto or prostate cancer (PC)-SPES
Patients who are unwilling to stop the use of herbal remedies while receiving study treatment
All herbal, alternative and food supplements (i.e. PC-Spes, saw palmetto, St. John's wort, etc.) must be discontinued before registration; subjects may continue on a daily multi-vitamin, calcium and vitamin D
Patient may not have had therapy modulating testosterone levels (such as luteinizing hormone, releasing-hormone agonists/antagonists and antiandrogens) within 6 months prior to randomization; agents such as 5 alpha reductase inhibitors, ketoconazole, abiraterone, systemic steroids, or herbal supplements known to decrease PSA levels including any dose of megestrol acetate, finasteride (e.g., saw palmetto and prostate cancer [PC]-SPES, African pygeum extract, lycopene, alanine, glutamic acid and glycine, beta-sitosterol, lycopene, nettle root extract, quercetin, Belizian Man Vine extract, muira puama extract and epimedium extract campesterol, stigmasterol, sitostanol and brassicasterol) are not permitted at any time during the period that the PSA values are being collected
All herbal medicines (eg, St. John's wort), vitamins, and supplements consumed by the subject within the 30 days prior to receiving the first dose of AMG 330
No alternative medications or nutraceuticals known to alter PSA (e.g. phytoestrogens and saw palmetto); Note: patients receiving medications for urinary symptoms such as Flomax or 5-alpha reductase inhibitors (finasteride and dutasteride) on a chronic stable dose for at least 3 months prior to study enrollment are allowed
Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) within 4 weeks of study drug administration (day 1)
Currently receiving any prohibited medications including vitamins and herbal supplements
Has received any of the following in the 4 weeks prior to randomization: 5-alpha-reductase inhibitors, herbal medications, natural hormonally active foods (e.g., phytoestrogens) or other food supplements known to alter PSA in humans
The use of any herbal products that may lower PSA levels (e.g. saw palmetto).
Use of herbal products that may decrease PSA levels (e.g. saw palmetto)
Use of herbal products that may decrease PSA levels (e.g. saw palmetto)
Received herbal products or alternative therapies that may decrease PSA levels or that may have hormonal anti-prostate cancer activity (e.g., saw palmetto, PC-SPES, PC- HOPE, St. John's wort, selenium supplements, grape seed extract, etc.) within 28 days of study treatment initiation or plans to initiate treatment with these products/alternative therapies during the entire duration of the study
STRATUM A: Participants must discontinue herbal preparations, herbal medication, and dietary supplements, with the exception of multivitamins, at least 7 days prior to study enrollment
STRATUM B: Participants must discontinue herbal preparations, herbal medication, and dietary supplements, with the exception of multivitamins, at least 7 days prior to study enrollment
STRATUM C: Participants must discontinue herbal preparations, herbal medication, and dietary supplements, with the exception of multivitamins, at least 7 days prior to study enrollment
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 7 days prior to the first dose of study drug and throughout participation in the trial.
Herbal supplements that have been shown to modulate testosterone or androgen signaling (e.g. Saw Palmetto) are not allowed while on study
Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g. phytoestrogens and saw palmetto)
Herbal products that may decrease PSA levels (e.g., saw palmetto) unless discontinued two weeks prior to randomization.
Use of herbal supplements unless discontinued >= 7 days prior to initiation of study drug
No use of herbal products that may decrease PSA levels within 4 weeks prior to enrollment
Patients may continue on a daily multi-vitamin, calcium and vitamin D, but all other herbal, alternative and food supplements (i.e. prostate cancer [PC]- hope [spes (Latin)], saw palmetto, St John’s wort, etc.) must be discontinued before starting protocol treatment; hormonal-acting agents such as diethylstilbestrol (DES) are forbidden during the trial and must be stopped starting protocol treatment; no washout period will be required; patients on megestrol acetate for hot flashes are allowed to continue therapy
Current use of natural herbal products or other complementary alternative medications (CAM) or “folk remedies”
Patients on herbs or other alternative medicines for the treatment of prostate cancer, including but not limited to saw palmetto, PC-SPES
Prior use of any herbal products known to decrease PSA levels (eg, PC-SPES or saw palmetto) within 30 days prior to the start of study medication.
Patients on herbs or other alternative medicines for the treatment of prostate cancer, including but not limited to saw palmetto, PC-SPES
Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids within 6 months of enrollment
Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g. phytoestrogens and saw palmetto)
Willing to stop herbal medications as directed by physician
User of herbal products
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 2 weeks; NOTE: Vitamin supplements are acceptable
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
Concomitant treatment with agents thought to have endocrine effects on prostate cancer: PC-SPES, saw palmetto
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
Use of herbal products that may decrease PSA levels (i.e., saw palmetto) (no washout period required)
Herbal, alternative remedies, and alcohol containing over-the-counter mouthwashes are excluded during the course of the study
Use of any medication or herbal products that may have hormonal anti-prostate cancer activity and/or are known to modulate PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within 4 weeks of enrollment
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
Herbal (e.g., saw palmetto) and non-herbal (e.g., pomegranate) products that may decrease PSA levels
Patients taking herbal or other alternative medicines for the treatment of prostate cancer, including but not limited to saw palmetto, prostate cancer (PC)-SPES
Patients may not use herbal or non-traditional medications while receiving AMG 232 therapy; all herbal medicines (e.g., St. John’s wort), vitamins, and supplements consumed by the subject within the 30 days prior to receiving the first dose of AMG 232 should be reviewed by the principal investigator
All herbal medicines (e.g., St. John’s wort), vitamins, and supplements consumed by the subject within the 30 days prior to receiving the first dose of AMG 232, and continuing use, if applicable, will 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 >= 14 days\r\n* NOTE: Vitamin supplements are acceptable
Patients may not use any complementary or alternative medicines including natural herbal products or folk remedies
Diethylstilbestrol, estrogens, saw palmetto, or other preparations that are known to have possible endocrine effects on prostate cancer that have been started within the past 8 weeks, as they may affect PSA levels or response; these are allowed if the patient has been on a stable dose for at least 8 weeks prior to cycle 1 day 1 (C1D1)
Patients receiving any other hormonal therapy, including any dose of megestrol acetate (Megace), Proscar (finasteride), any herbal product known to decrease prostate specific antigen (PSA) levels (e.g. saw palmetto, PC-SPES), or any systemic corticosteroid, must discontinue the agent for at least 30 days prior to study treatment
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
Subject received treatment with herbal medications that have known hormonal antiprostate cancer activity and/or are known to decrease PSA levels within 4 weeks prior to day 1.
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 7 days of starting study therapy
Patients must not be concurrently taking other medications or supplements with known hormonal effects (other than LHRH agonists or non-steroidal antiandrogen), including prostate cancer (PC)-SPES, megestrol acetate, finasteride, ketoconazole, estradiol, or saw palmetto; all other medications with possible anti-cancer effects must be discussed with the protocol principal investigator prior to study entry
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
Are planning to start certain medications after the trial enrollment; no new finasteride (Proscar) or other hormonal agents for chemoprevention/treatment of benign prostate hyperplasia (BPH); utilizing new prescription medications for urinary outlet obstructive symptoms will result in discontinuing participation in this study; the use of new non-prescription substances to improve urinary tract symptoms will also result in discontinuing participation (i.e. saw palmetto, other herbal, alternative products); men who are currently taking finasteride or medications (meds) for urinary outlet obstructive symptoms may enroll in the study as long as there is no plan to change the dose in the weeks prior to surgery
All herbal medicines (e.g., St. John’s wort), vitamins, and supplements consumed by the subject within the 30 days prior to receiving the first dose of AMG 232, and continuing use, if applicable, will be reviewed by the principal investigator
Participants must agree not to use natural herbal products or other “folk remedies” while participating in this study
Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g. phytoestrogens and saw palmetto)
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 7 days prior to the first dose of the study drug
Therapies that must be discontinued or substituted at least 4 weeks prior to randomization include the following: a) Medications known to lower the seizure threshold, b) Herbal and non-herbal products that may decrease PSA levels (example [eg], saw palmetto, pomegranate) or c) Any investigational agent
Therapies that must be discontinued or substituted prior to Treatment Cycle 1, Day 1 include the following: Medications known to lower the seizure threshold; Herbal and non-herbal products that may decrease prostate specific antigen (PSA) levels (that is, saw palmetto, pomegranates or pomegranate juice); Medications known to induce drug metabolizing enzymes such as dexamethasone, rifampicin, carbamazepine, phenytoin, phenobarbital, St. John's wort, etc.; and, potent inhibitors of CYP3A4 or CYP2C8
Use of herbal products that may decrease PSA levels (e.g., saw palmetto)
Use of herbal products that may decrease PSA levels (i.e., saw palmetto) or systemic corticosteroid greater than the equivalent of 10 mg of prednisone per day during the 4 weeks prior to screening or plans to initiate treatment with the above during the entire duration of the study
Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of replacement steroids or > equivalent of 10 mg of prednisone per day within 4 weeks of enrollment (day 1 visit)
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
No use of herbal products that may decrease PSA levels within 4 weeks prior to enrollment
Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within 2 weeks of enrollment
Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g. phytoestrogens and saw palmetto)
Use of herbal products that may decrease PSA levels (e.g. saw palmetto)
Use of herbal products that may decrease PSA levels (e.g. saw palmetto)
Patients receiving any other hormonal therapy, including any dose of megestrol acetate (Megace), Proscar (finasteride), any herbal product known to decrease PSA levels (e.g. Saw Palmetto, PC-SPES), or agents such as abiraterone, TAK700, MDV3100 as well as any systemic corticosteroid use, must discontinue the agent for at least four weeks prior to study treatment. Progressive disease as defined above must be documented after discontinuation of any hormonal therapy (with the exception of a LHRH agonist).
Unwillingness to stop taking herbal supplements while on study
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
Patients may continue on a daily multi-vitamin, calcium and vitamin D, but all other herbal, alternative and food supplements (i.e. PC-Spes, saw palmetto, St John’s wort, etc.) must be discontinued before registration; patients must not be planning to receive any concurrent cytotoxic chemotherapy, surgery, or radiation therapy during protocol treatment; hormonal-acting agents (including diethylstilbestrol/DES, aldosterone, and spironolactone) are forbidden during the trial and must be stopped prior to registration; no washout period will be required for any of these agents; patients on megestrol acetate for hot flashes are allowed to continue therapy
Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart), or any herbal product known to decrease PSA levels (e.g., saw palmetto and PC-SPES), or any systemic corticosteroid (other than prednisone =< 10 mg/day) within 4 weeks prior to first dose of study drug
Patients receiving any herbal product known to decrease PSA levels (i.e. saw palmetto and prostate cancer [PC]-SPES), or any immunosuppressive dose of systemic or absorbable topical corticosteroid (except prednisone up to 10 mg orally per [q] day, or its equivalent), must discontinue the agent for at least 2 weeks prior to screening; progressive disease must be documented after discontinuation of these products
Patients who are unwilling to stop the use of herbal remedies while on the treatment phase of the study
Patients must not be concurrently taking other medications or supplements with known hormonal effects, including PC-SPES, megestrol acetate, finasteride, ketoconazole, estradiol, or Saw Palmetto; all other medications with possible anti-cancer effects must be discussed with the principal investigator (PI) prior to study entry
Intake of any herbal preparations or medications (e.g., including, but not limited to, Saint-Johns wort and ginkgo biloba) and dietary supplements within 7 days prior to first dose of study drug
All subjects must agree to stop the use of all herbal medicines (e.g., St. John’s wort), and supplements, within the 10 days prior to receiving the first dose of AMG 232, and during the protocol AMG 232 treatment (weeks 1-5); subjects may renew the use of the above at week 6; standard adult multi-vitamin is allowed
Patients may not use natural herbal products or other “folk remedies” while participating in this study
Patients shall not receive any herbal/alternative therapies such as flaxseed or soy products or black cohosh
Concurrent administration of herbal preparations.
Therapy with herbal products known to effect PSA, or estrogen within 30 days prior to the start of study medication
Herbal preparations or over-the-counter supplements containing herbal ingredients (St. John’s wort, Estroven, blue cohosh) are prohibited during treatment and must be stopped within 24 hours (h) of first dose of dasatinib
Therapy with other hormonal therapy, including any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES) within 4 weeks prior to receiving first dose of study drug.
Patients receiving hormonal therapy (i.e. any dose of megestrol acetate [Megace], Proscar [finasteride], any herbal product known to decrease PSA levels [e.g., Saw Palmetto and PC-SPES]) other than LHRH agonist/antagonist or a stable dose of corticosteroid from a prior chemotherapy regimen must discontinue the agent for at least 28 days prior to enrollment
Patients who have taken herbal medications and certain fruits within 7 days prior to starting study drug, see section 11.1.2.7.
Patient is currently using herbal preparations or medications. Patient should stop using herbal medications 7 days prior to the first dose of the study drug.
During time of study period, subjects must agree not to take any new vitamin supplementation or herbal remedy
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 6 weeks of day 1 of protocol therapy
Patients receiving herbal preparations/medications
Patients who have taken 5-alpha-reductase inhibitors (finasteride or dutasteride), saw palmetto, or PC-SPES within the last 6 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 > 2 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 CYP3A4
Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA values (e.g., saw palmetto) or systemic corticosteroids for prostate cancer within 4 weeks of day 29 visit (start of enzalutamide and ADT)
Chronic use of any herbal or dietary supplement containing apigenin within the 3 months prior to entry on the study
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 4 weeks) or planned therapies: antineoplastic chemotherapy, androgens, estrogens, progestational agents, other herbal supplements, including soy (herbal teas from a store are allowed), or Warfarin (1 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
Chronic use of any herbal or dietary supplement containing curcumin or curcuminoids within the 3 months prior to entry on the study or any other supplements that might interact with NEC
Certain medicines and herbal remedies taken during the 7 days before the start of study drug
Patients may continue on a daily multi-vitamin, calcium and vitamin D, but all other herbal, alternate and food supplements (i.e. PC-Spes, saw palmetto, St John wort, etc.) must be discontinued before treatment start; patients must not be planning to receive any concurrent cytotoxic chemotherapy, surgery for their prostate cancer, or radiation therapy during protocol treatment
Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g. phytoestrogens and saw palmetto) cannot be taken while patients are receiving enzalutamide
Use, in the 2 months prior to week 1 visit, of antibiotics, hormone replacement therapy, nonprescription hormones or herbal supplements for menopausal symptoms, or flaxseed supplements
Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within 4 weeks of enrollment