Downloads: 1
| # | Blank 1 | Frequency | Blank 2 | Frequency | |
|---|---|---|---|---|---|
| 1 | 11 | prior therapy with hydroxyurea chemotherapy biological or targeted therapy e | 4 | 20 | |
| 2 | 1 | concomitant use either of warfarin and / or 3 hydroxy 3 methylglutaryl coenzyme a hmg coa reductase inhibitors statins | 1 | g . flt3 inhibitors other kinase inhibitors or hematopoietic growth factors is allowed | 4 |
| 3 | 2 | first generation ar antagonists e | 1 | g . bicalutamide nilutamide flutamide 5 alpha reductase inhibitors ketoconazole estrogens including diethylstilbesterol des or progesterones | 1 |
| 4 | 3 | is receiving an monoamine oxidase inhibitors maoi or any drug which has significant maoi activity e | 1 | g . meperidine linezolid methylene blue within the 21 days before screening or has a history of serotonin syndrome after receiving serotonergic drugs . | 1 |
| 5 | 4 | ongoing therapy with a p gp inhibitor e | 1 | g . nelfinavir indinavir or saquinavir protease inhibitors for hiv as these drugs interact with the factor xa inhibitors | 1 |
| 6 | 5 | taking other immunosuppressant drugs for gvhd including mtor inhibitors note only steroids calcineurin inhibitors and ecp are acceptable | 1 | g . flt3 inhibitors other kinase inhibitors or hematopoietic growth factors is permitted in cohort 1 and 2 . | 1 |
| 7 | 6 | prior treatment with erk inhibitors | 1 | g . finasteride or dutasteride within 180 days prior to registration . | 1 |
| 8 | 7 | etc | 1 | john s wort hypericum perforatum r n 3 hydroxy 3 methyl glutaryl coenzyme a hmg coa reductase potential 10 inhibitors lovastatin simvastatin r n neuroleptic pimozide r n proton pump inhibitors r n sedative / hypnotics midazolam triazolam | 1 |
| 9 | 8 | patients on 5 alpha reductase inhibitors such as finasteride or dutasteride must stop medication at least 28 days prior to study entry | 1 | g . patients with kidney cancer do not need all tyrosine kinase inhibitors patients with melanoma do not need all approved checkpoint blockade inhibitors | 1 |
| 10 | 9 | previous treatment with dual pi3k / mtor inhibitors torc1 / 2 inhibitors or torc1 inhibitors | 1 | john s wort | 1 |
| 11 | 10 | prior therapy with hydroxyurea biological or targeted therapy e | 1 | g . everolimus temsirolimus is not allowed prior therapy with mek inhibitors e . g . azd6244 or selumetinib is not allowed | 1 |
| 12 | 13 | 5 alpha reductase inhibitors e | 1 | g . finasteride dutasteride estrogens and / or cytproterone within 4 weeks of the screening visit | 1 |
| 13 | 15 | patients receiving the following drugs that are contraindicated with nfv will be excluded r n antiarrhythmics amiodarone quinidine r n antimycobacterial rifampin r n ergot derivatives dihydroergotamine ergonovine ergotamine methylergonovine r n herbal products st | 1 | baseline psa must be established after a minimum of 3 months following 5 aris discontinuation . additionally use of 5 aris is not permitted following treatment during the study follow up period . | 1 |
| 14 | 16 | patients are not required to have all approved therapies in a drug class e | 1 | patients on antiandrogens for < 3 months must be off medication for 2 weeks . patients on 5 alpha reductase inhibitors such as finasteride proscar propecia or dutasteride avodart must stop medication at least 3 months from study entry . | 1 |
| 15 | 17 | patients receiving the following drugs that are contraindicated with nfv will be excluded antiarrhythmics amiodarone quinidine antimycobacterial rifampin ergot derivatives dihydroergotamine ergonovine ergotamine methylergonovine herbal products st | 1 | g . tnf pathway inhibitors phosphoinositide 3 pi3 kinase inhibitors within 7 days of study treatment | 1 |
| 16 | 18 | patients may have received non cytotoxic biologic or targeted agent s as part of initial treatment and / or for management of recurrent or persistent disease with the below stated exceptions see note below prior hormonal therapy is allowed but must be discontinued at least one week prior to registration r n note prior therapy with pi3k inhibitors akt inhibitors and / or mammalian target of rapamycin mtor inhibitors e | 1 | g . azacitidine decitabine histone deacetylase inhibitors tyrosine kinase inhibitors hematopoietic growth factors interferon but excluding hydroxyurea and cyclophosphamide for at least 2 weeks prior to starting induction chemotherapy | 1 |
| 17 | 19 | subjects on 5 alpha reductase inhibitors such as finasteride proscar propecia or dutasteride avodart within 28 days of study drug initiation | 1 | g . hypomethylating agent or mek inhibitor | 1 |
| 18 | 20 | for cohort c has received treatment with 5 reductase inhibitors e | 1 | g . finasteride dutasteride within 90 days prior to preregistration are not eligible treatment with these agents during the protocol intervention is not permitted | 1 |
| 19 | 21 | monoamine oxidase inhibitors | 1 | g . dizziness nausea sleep disturbance or other sensory disturbances patients must not have previously taken the serotonin norepinephrine reuptake inhibitors snri dmcLoxetine or milnacipran prior venlafaxine is allowed as long as it was not taken concurrently with ai therapy and was not taken for treatment of pain e . g . prior treatment for hot flashes is permitted r n note patients requiring antidepressants for management of depression are not appropriate candidates for this placebo controlled study but those who are on antidepressants for other indications | 1 |
| 20 | 22 | use of 5 alpha reductase inhibitors 5 aris or hormone therapy within 3 months prior to the baseline visit | 1 | NA | |
| 21 | 23 | prior use of targeted therapy agents eg flt3 inhibitors other kinase inhibitors | 1 | NA | |
| 22 | 24 | subject received treatment with 5 reductase inhibitors finasteride dutasteride within 4 weeks prior to day 1 | 1 | NA | |
| 23 | 25 | use of estrogens or 5 reductase inhibitors or ar inhibitors | 1 | NA | |
| 24 | 27 | the patient must have received no more than 2 prior regimens with vegf inhibitors and 1 prior regimen with checkpoint inhibitors for metastatic disease | 1 | NA | |
| 25 | 28 | patients who have received antiandrogens such as flutamide emcLexin bicalutamide casodex or nilutamide nilandron for > = 3 months must be off treatment for 6 weeks and demonstrate a continued rise in psa after withdrawal | 1 | NA | |
| 26 | 29 | patients on immunosuppressive agents e | 1 | NA | |
| 27 | 30 | patients must be off all non cytotoxic chemotherapies or biologic agents e | 1 | NA | |
| 28 | 31 | prior treatment with immunotherapy agents including but not limited to tumor necrosis factor receptor superfamily agonists or checkpoint inhibitors or natural killer nk cell inhibitors | 1 | NA | |
| 29 | 32 | subjects shomcLd have received no anti leukemic therapy except hydroxyurea prior to the first dose of crenolanib as follows for 14 days for classical cytotoxic agents and for five times the t1 / 2 half life for flt3 inhibitors and antineoplastic agents that are neither cytotoxic nor flt3 inhibitors e | 1 | NA | |
| 30 | 33 | patients receiving treatment with 5 alpha reductase inhibitors e | 1 | NA | |
| 31 | 34 | for patients previously treated with other agents approved for the treatment of prostate cancer 5 reductase inhibitors estrogens others discontinuation of therapy must have occurred 4 weeks prior to start of study drug | 1 | NA | |
| 32 | 35 | lead in cohort resistant or intolerant to 1 or more janus kinase inhibitors licensed or experimental | 1 | NA | |
| 33 | 36 | prior treatment with small molecmcLe inhibitors of the met pathway | 1 | NA | |
| 34 | 37 | prior treatment with a gamma secretase inhibitors or other notch signaling inhibitors | 1 | NA | |
| 35 | 38 | current and continued use during study treatment period of known breast cancer resistance protein bcrp inhibitors or known p gp inhibitors | 1 | NA | |
| 36 | 39 | subjects taking selective serotonin reuptake inhibitors ssris | 1 | NA | |
| 37 | 40 | patients must not require selective serotonin reuptake inhibitors ssris or tricyclic antidepressants during study participation patients must have been able to taper and discontinue treatment with these medications at least 7 days prior to registration 28 days for fluoxetine and must not be experiencing antidepressant withdrawal symptoms e | 1 | NA | |
| 38 | 41 | subject has known contraindication or allergy to both xanthine oxidase inhibitors and rasburicase | 1 | NA |