[c09aa8]: / clusters / final9knumclusters / clust_411.txt

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Received any biological and/or targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management and/or treatment of epithelial ovarian or peritoneal primary cancer
Immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks prior to treatment with the trial drug
Patients who have received >= 7 days of prior ibrutinib or any prior treatment with another Bruton tyrosine kinase (BTK) inhibitor are not eligible
The addition of cytotoxic agents for “cytoreduction” with the exception of tyrosine kinase inhibitors (such as imatinib), cytokine therapy, hydroxyurea, low dose cytarabine, chlorambucil, or Rituxan will not be allowed within three weeks of the initiation of conditioning
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patient will not be enrolled if they received prior chemotherapy within 2 weeks before enrollment with the following exceptions: to reduce the circulating lymphoblast count or palliation (i.e., steroids or hydroxyurea) or for ALL maintenance (mercaptopurine, methotrexate, vincristine, thioguanine, and/or tyrosine kinase inhibitors)
ELIGIBILITY CRITERIA - PHASE II (ARM D): Patient will not be enrolled if they received prior chemotherapy within 2 weeks before enrollment with the following exceptions: to reduce the circulating lymphoblast count or palliation (i.e., steroids or hydroxyurea), for ALL maintenance (mercaptopurine, methotrexate, vincristine, thioguanine, and/or tyrosine kinase inhibitors)
Received prior tyrosine kinase inhibitor therapy or palliative radiation within 7 days of first dose of study treatment.
Renal cell patients must have had at least one prior VEGF tyrosine kinase inhibitor (TKI)
Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
For Phase 2 - Prior exposure to a receptor tyrosine kinase or mammalian target of Rapamycin inhibitor
Must have received at least one course of therapy with a VEGFR-targeting tyrosine kinase inhibitor (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib) and progressed within 6 months of planned first dose of study treatment
Untreated disease EXCEPT for corticosteroids, hydroxyurea, leukapheresis, and/or tyrosine kinase inhibitors for up to 2 weeks prior to initiation of study therapy
Eligible participants must have received at least one line of prior therapy; note: patients will be eligible for participation despite prior treatment with known RET tyrosine kinase inhibitors (TKIs) (e.g. vandetanib, sorafenib, XL-184)
Prior EGFR tyrosine kinase inhibitor therapy (including gefitinib, erlotinib, or any experimental EGFR tyrosine kinase inhibitor [TKI] agent)
Resistance or intolerance to prior kinase inhibitor therapy (e.g., lenvatinib, sorafenib). A patient who is considered inappropriate for, or who has refused, kinase inhibitor therapy may be enrolled with approval of the Medical Monitor.
Participants who have had oral targeted therapy or oral tyrosine kinase inhibitors (TKIs) within 5 half-lives prior to entering the study
Allowable prior therapies:\r\n* Subjects must have had clinical or radiographic progression on imatinib; those who were taken off of imatinib for intolerance must have progressed on at least one other tyrosine kinase inhibitor (TKI)\r\n* Subjects must have received >= 1 prior systemic therapy (including imatinib); a maximum of 4 prior therapies for metastatic disease are allowed
Treatment with chemotherapy (not including tyrosine kinase inhibitors) or radiotherapy within 4 weeks (6 weeks from nitrosoureas or mitomycin C), or treatment with monoclonal antibody therapy within 4 weeks prior to start of study treatment\r\n* Note: no minimum washout period is required for tyrosine kinase inhibitor therapy (eg, imatinib or sunitinib)
Participants who have received prior oral tyrosine kinase inhibitors (TKIs) will be allowed on study if at least 5 half-lives have elapsed since the date of their last dose of TKI
If using hydroxyurea, tyrosine kinase inhibitors (TKIs)/src inhibitors (including fms related tyrosine kinase 3 [FLT-3] inhibitors), other non-cytotoxics, or leukapheresis for blast count control, the patient must be off these therapies for >= 24 hours (hrs) before starting sertraline
Previous therapy with Bruton's tyrosine kinase (BTK) inhibition
Previous anti-cancer and investigational agents within 2 weeks before first dose of INC280; if previous treatment is a small molecule tyrosine kinase inhibitor (TKI), last dose must be at least 7 days before first dose of INC280; a shorter washout period may be allowed after discussion with the principal investigator
Molecular targeted agents including monoclonal antibodies and tyrosine kinase inhibitors: at least two weeks since last therapy
Patients who have received prior therapy targeting EGFR with small molecule tyrosine kinase inhibitors or monoclonal antibodies are NOT eligible
Treated with at least one line of chemotherapy in the palliative setting or with neoadjuvant or adjuvant chemotherapy within the prior six months; the allowable window between treatments is 21 days for chemotherapy or a tyrosine kinase inhibitor (TKI) or 5 half-lives for a TKI (whichever is shorter), 21 days and progression by CT for immunotherapy, 21 days for RT, 21 days for surgery, or 28 days for an investigational agent
Prior therapy with EGFR tyrosine kinase inhibitor (TKI) therapy
Subjects with Ph+ disease are eligible if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have relapsed/refractory disease despite treatment with at least 2 different TKIs
Chemo-, or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 2 weeks prior to treatment with the trial drug
May have received prior hormonal therapy in the context of definitive treatment of a primary tumor\r\n* Patients may have had one prior systemic non-chemotherapeutic treatment (i.e. immunotherapy, receptor tyrosine kinase inhibitor, antiangiogenic agent, differentiating agent) for recurrent or metastatic disease
Any line of prior treatment for patients under 65 years (y), over 65y must have at least one prior line of tyrosine kinase inhibitor (TKI) treatment (excluding anaplastic patients).
The addition of cytotoxic agents for “cytoreduction” with the exception of tyrosine kinase inhibitors (such as imatinib), cytokine therapy, hydroxyurea, low dose cytarabine, chlorambucil, or Rituxan will not be allowed within three weeks of the initiation of conditioning
Patients with activating EGFR mutation or ALK rearrangement which is expected to be responsive to available tyrosine kinase inhibitor therapy, must have been previously treated with an applicable tyrosine kinase inhibitor
For participants in the dose-finding phase, a minimum washout period of at least 5 half-lives between the last dose of tyrosine kinase inhibitors (TKI) therapy and the first dose of study treatment is required; for patients on crizotinib, a 7 day washout is sufficient; a shorter washout period may be considered in the event of disease flare, after discussion with the sponsor; no washout is required if the most recent anti-neoplastic therapy is alectinib
Concurrent use of other tyrosine kinase inhibitors
Chemotherapy, tyrosine kinase inhibitor, or radiation therapy within 4 weeks
Prior to initiating chemotherapy in this study, twenty-one or more days must have elapsed since the patient's last radiation or chemotherapy administration (Hydrea, Gleevec and other tyrosine kinase inhibitors [TKI] as well as intrathecal therapy are accepted exceptions).
Receipt of the tyrosine kinase inhibitor sunitinib within 90 days before the first dose of study therapy
Chemotherapy administration in the 14 days preceding enrollment with the exception of hydroxyurea, which can be continued until through cycle 2; a washout period for oral tyrosine kinase inhibitors (e.g. Jakafi, etc) is not required, although tyrosine kinase inhibitors therapy must be discontinued prior to enrollment
Known severe allergic or other prohibitive reactions to other tyrosine kinase inhibitors (TKI)
Receipt of the last dose of chemotherapy or tyrosine kinase inhibitors should be at least 3 weeks prior to durvalumab and tremelimumab dosing; monoclonal antibodies such as bevacizumab, ziv-aflibercept, ramucirumab, cetuximab, and panitumumab should be at least 6 weeks prior to durvalumab and tremelimumab therapy
Patients must be receiving treatment or planning to start treatment with a tyrosine kinase inhibitor targeting the activated gene
Previous chemotherapy except for antiangiogenic agent or tyrosine kinase inhibitor (TKI) will be allowed as long as it is more than 5 years
Prior therapy with any HER2 directed tyrosine kinase inhibitor (TKI) (e.g., lapatinib, afatinib, dacominib, neratinib, capecitabine) or anti-EGFR antibody therapy (e.g., cetuximab)
Chemotherapy, hormonal therapy, radiotherapy (except for brain and extremities), immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks prior to treatment with the trial drug
Has received prior therapy with an EGFR tyrosine kinase inhibitor (such as erlotinib, gefitinib, afatinib, rociletinib, or AZD9291) for NSCLC
The patient has received chemotherapy, surgery, radiotherapy (for therapeutic purposes), tyrosine kinase inhibitor (TKI) (e.g. erlotinib, gefitinib), investigational drugs, chronic use of systemic corticosteroids or statin therapy within 2 weeks prior to leukapheresis.
Patients must have discontinued systemic antineoplastic therapy (including systemic corticosteroids and excluding tyrosine kinase inhibitors for CML) at least four (4) weeks prior to enrollment.
Patients receiving cytotoxic therapy, radiation therapy, immunotherapy or non-topical steroids for HM within four (4) weeks of enrollment, excluding tyrosine kinase inhibitors in patients with CML.
CLL who are beyond first remission and who have failed combination chemoimmunotherapy with regimens containing a purine analogue and anti-CD20 antibody, or who have failed tyrosine kinase or phosphatidylinositol 3 (PI3) kinase inhibitors, or who were not eligible for or declined such therapy; patients with fludarabine refractory disease are eligible
Patients must demonstrate progressive disease at the time of treatment\r\n*Note: patients who have received tyrosine kinase inhibitors (e.g. vemurafenib) may be treated if they present with stable disease at the time of treatment
Treatment with crizotinib within 7 days prior to enrollment; for all other ALK tyrosine-kinase inhibitors (TKIs), the washout period should be >= 5 half-lives prior to enrollment
Phase 1: Subjects must have previously received and progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI). Additional lines of systemic therapy including investigational agents for locally advanced or metastatic NSCLC are allowed.
Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of trametinib and during the study; patients previously treated with v-raf murine sarcoma (RAF) and/or mitogen-activated protein kinase (MEK) inhibitors are excluded from the study; multikinase antiangiogenic tyrosine kinase inhibitors such as regorafenib, sorafenib, sunitinib, etc. whose primary mechanism of action is not RAF inhibition, are allowed; if there are any questions, please contact study's principal investigator
Chemotherapy, immunotherapy, biologically targeted therapy, other investigational agent, or radiation therapy within 3 weeks of initiation of enzalutamide therapy; for patients with objectively progressive disease on a Bruton tyrosine kinase (BTK)-targeting agent whom in the opinion of the investigator would not tolerate a 21 day washout period, a > 5 half-lives washout period will be allowed
Prior chemotherapy/radiotherapy/investigational therapy within 2 weeks before the start of study drugs with the following exceptions: \r\n* To reduce the circulating lymphoblast count or palliation: steroids, hydroxyurea; no washout necessary for these agents \r\n* For ALL maintenance/CML treatment: mercaptopurine, methotrexate, vincristine, single-agent, single-dose of cytarabine and/or tyrosine kinase inhibitors; these agents should be discontinued at least 48 hours prior to start of study drugs; (Note: the interval of time from last dose of any approved tyrosine kinase inhibitor [TKI] to start of protocol treatment is 48 hours regardless of the indication for treatment with the TKI)
Prior treatment with VEGFR tyrosine kinase inhibitors
Previous therapy with T-DM1 or any HER2 tyrosine kinase inhibitor (TKI) including neratinib for any malignancy.
Prior treatment with any VEGFR tyrosine kinase inhibitor
Prior use of MEK162 or concurrent use of other approved anticancer or investigational agents is not allowed; patients treated with prior EGFR tyrosine kinase inhibitor (TKI) therapy (including erlotinib) are allowed to enroll
Prior bevacizumab or tyrosine-kinase inhibitor
Have not received a tyrosine kinase inhibitor (TKI) with activity against the specific documented EGFR exon 20 insertion.
Treatment with chemotherapy or targeted therapy (e.g. tyrosine kinase inhibitor) =< 28 days prior to registration
Patient with known hypersensitivity to receptor tyrosine kinase inhibitors or any of the components of poziotinib tablets or T-DM1 IV solution.
Ongoing or previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFRspecific antibodies) or with taxanes or vinflunine
Received any kinase inhibitors within 2 weeks prior to study treatment.
Prior treatment with phosphatidylinositol 3-kinase (PI3K) delta inhibitors, Bruton's tyrosine kinase (BTK) inhibitors, janus kinase inhibitor (JAK) inhibitors, mammalian target of rapamycin (mTOR) inhibitors, or spleen tyrosine kinase (Syk) inhibitors
Patients receiving systemic chemotherapy (includes tyrosine kinase inhibitors)
Patients who have received therapy with an oral tyrosine kinase inhibitor (eg, erlotinib) within 14 days prior to entry into the protocol.
Prior treatment with a tyrosine kinase c-kit inhibitor
Previous treatment with any Tyrosine Kinase Inhibitor
Patient previously treated by tyrosine kinase inhibitors except imatinib in case of inclusion criteria 2
Patient has received any chemotherapy, surgery, radiotherapy (for therapeutic purposes), tyrosine kinase inhibitors, investigational drugs, chronic use of systemic corticosteroids or statin therapy within 2 weeks prior to the leukapheresis
Patients who have had immunotherapy or tyrosine kinase inhibitor (TKI) therapy within two weeks prior to entering the study
Prior systemic anti-cancer treatment (e.g. chemotherapy, tyrosine kinase inhibitors, immunotherapy, or investigational agents)(except for hydroxyurea and/or leukapheresis)
Patients at least 3 weeks from last cytotoxic chemotherapy. Patients may continue tyrosine kinase inhibitors or other targeted therapies until at least two weeks prior to administration of lymphodepleting chemotherapy.
Group 1 - patients must have pathologically documented, definitively diagnosed locally advanced or metastatic NSCLC with a RET rearrangement that was previously treated with a tyrosine kinase inhibitor (TKI) that inhibits RET, such as cabozantinib, vandetanib, ponatinib, sorafenib and alectinib.
Phase 2 Only: Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting TRK, including entrectinib, crizotinib and lestaurtanib. Patients who received a TRK inhibitor for less than 28 days of treatment and discontinued because of intolerance remain eligible.
Patients enrolled to the prior treatment arm of the expansion cohort must have been exposed to a tyrosine kinase inhibitor (TKI) for metastatic disease; exposure to TKI as part of (neo)adjuvant treatment that completed within 1 year of study qualifies as prior exposure as well
Patients who have received prior treatment with tyrosine kinase inhibitors (e.g. erlotinib), or anti-EGFR agents (e.g. cetuximab, panitumumab)
Patients who have received hydroxyurea alone or have previously received “non-cytotoxic” therapies for myelodysplastic syndromes (MDS) or myeloproliferative neoplasms (MPN) (e.g., thalidomide or lenalidomide, 5-azacytidine or decitabine, histone deacetylase inhibitors, low-dose Cytoxan, tyrosine kinase or dual tyrosine kinase [TK]/SRC inhibitors) will be allowed
Prior exposure to a Bruton agammaglobulinemia tyrosine-protein kinase (BTK) inhibitor
Prior therapy with a tyrosine kinase inhibitors (TKI) other than nilotinib is allowable, however, nilotinib must be the current therapy; all patients must be under the care of a Moffitt Cancer Center physician, and enrollment is expected to be complete within six months
Patients must not have received any prior systemic anticancer therapy for advanced or metastatic disease including chemotherapy or EGFR tyrosine kinase inhibitor therapy (including gefitinib, erlotinib, afatinib, or any experimental EGFR tyrosine kinase inhibitors [TKI] agents); prior chemotherapy for non-metastatic disease (i.e. adjuvant therapy or concurrent chemo-radiotherapy) is allowed as long as > 12 months has passed since completion of therapy; adjuvant EGFR-directed therapy is not allowed; local therapy (i.e. palliative radiotherapy) is allowed as long as a period of 7 days has passed since the last dose was received and the patient has recovered from any associated toxicity at the time of registration
Received previous therapy with capecitabine, neratinib, lapatinib, or any other HER2 directed tyrosine kinase inhibitor.
Progressive disease with radiographic evidence of disease progression per investigator assessment during therapy with an EGFR tyrosine kinase inhibitor in the metastatic setting; patients may continue EGFR inhibitor therapy throughout the screening period until the day prior to nab-paclitaxel treatment initiation
Prior exposure to EGFR tyrosine kinase inhibitors
Part 1: Progression of disease following up to three lines of prior therapy, including at least one approved VEGF receptor tyrosine kinase inhibitor for RCC. Adjuvant therapy is permitted as one line of prior therapy.
Tyrosine kinase inhibitors and hydroxyurea must be stopped > 72 hours prior to CTL019 infusion
Prior treatment with any VEGFR tyrosine kinase inhibitor
Treatment with kinase inhibitors </= 2 weeks before study treatment
Prior systemic regimens must include previously approved therapies, including a platinum-containing chemotherapy regimen; a tyrosine kinase inhibitor for tumors with driver mutations; and checkpoint inhibitors where approved.
Prior treatment with lenvatinib or any tyrosine kinase inhibitor (TKI) - (except for combination therapy of radiation and reduced dose of TKI given for the purpose of radiosensitization).
Previous treatment with another Bruton's Tyrosine Kinase (BTK) -inhibitor.
No Bruton’s tyrosine kinase inhibitor at any point prior to enrollment
Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor
Prior tyrosine kinase inhibitor therapy or palliative radiation within 7 days of first dose of study medication
Patients must be willing to be off EGFR-tyrosine-kinase inhibitor (TKI) therapy for a minimum of one week; (in expansion cohort A patients on erlotinib do not have to discontinue treatment)
The addition of cytotoxic agents for “cytoreduction” with the exception of tyrosine kinase inhibitors (such as imatinib mesylate), cytokine therapy, hydroxyurea, low dose cytarabine, chlorambucil, or Rituxan will not be allowed within three weeks of the initiation of conditioning
Arm B only: ibrutinib or other Bruton's tyrosine kinase (BTK) inhibitor;
Patients who have previously received ibrutinib or another inhibitor of Bruton's tyrosine kinase (BTK)
Patients at least 3 weeks from last cytotoxic chemotherapy; patients may continue tyrosine kinase inhibitors and/or lenalidomide until the day of study consent
Prior therapy with ibrutinib or other kinase inhibitors that target Bruton’s tyrosine kinase (BTK); patients who previously received therapy with the phosphoinositide-3 kinase (PI3K) delta inhibitor idelalisib (Zydelig) are allowed to be enrolled
Chemotherapy, radiotherapy or immunotherapy must have stopped more than 14 days prior to receiving study drug; however, small field palliative radiotherapy, tyrosine-kinase inhibitor (TKI) therapies, and hormonal therapies are allowed
Newly diagnosed previously untreated ALL or lymphoblastic lymphoma; allow urgent administration of cytarabine/hydroxyurea (hydrea)/all-trans retinoic acid (atra) prior to starting treatment on protocol; allow previous administration of up to one course of hyper-CVAD and/or Food and Drug Administration (FDA) approved tyrosine kinase inhibitor (TKI)
Prior or concurrent therapy with a Janus kinase inhibitor or Bruton's tyrosine kinase inhibitor
Subjects with Ph+ disease are eligible if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have relapsed/refractory disease despite treatment with at least 2 different TKIs
Participants who have had < 28 days since the last chemotherapy, immunotherapy, biological therapy, or < 14 days from approved tyrosine kinase inhibitor (TKI) therapy (sunitinib, sorafenib, vemurafenib, dabrafenib, cobretinib), or systemic or inhaled steroid therapy at doses greater than 10mg of prednisone or equivalent before administration of the first dose of study medication.
Chemo-, hormone-, radio-(except for brain and extremities) or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks prior to treatment with the trial drug.
Prior chemotherapy or tyrosine kinase inhibitor (TKI) treatment, aside from dasatinib, must be >= 7 days before first investigational agent dose
Have T790M-positive status using a test validated and performed locally after disease progression on EGFR tyrosine kinase inhibitor (TKI) treatment.
Known cysteine-481 Bruton's tyrosine kinase (BTK) mutation or CLL refractory to or progressed during ibrutinib or other cysteine (Cys)-481 binding BTK inhibitor treatment
Twenty-one or more days must have elapsed since the patient's last radiation or chemotherapy administration before beginning treatment for stem cell transplant; Hydrea, Gleevec and other tyrosine kinase inhibitors (TKI) as well as intrathecal therapy are accepted exceptions
Patients who have received EGFR tyrosine kinase inhibitors within 72 hours of initiation of study treatment, or treatment with other anti-cancer agents within 21 days of study treatment
Previous therapy with ibrutinib, or any drug that specifically inhibits Bruton's tyrosine kinase (BTK)
Any prior treatment with an aurora kinase inhibitor (either an aurora A kinase or pan-aurora kinase inhibitor)
History of treatment with a tyrosine kinase inhibitor (eg, imatinib), purine analogs or other cancer chemotherapy in the 4 weeks prior to starting study drug.
Any prior medical treatment for CML, including tyrosine kinase inhibitors (TKIs), with the exception of hydroxyurea and/or anagrelide treatment, which are permitted for up to 6 months prior to study entry (signature of ICF) if suitably approved for use in the subject's region.
No prior chemotherapy, Bruton's tyrosine kinase (BTK) inhibitor therapy, or monoclonal anti-body therapy for treatment of CLL or SLL
?2 prior Tyrosine Kinase Inhibitors (TKI) therapies for CML
Tyrosine kinase inhibitor within 7 days of randomization
Patients must not have received prior therapy with a tyrosine kinase inhibitor (TKI)
No prior treatment with erlotinib, gefitinib, or other EGFR tyrosine kinase inhibitors
Subjects (other than those in the ibrutinib + JCAR017 combination therapy arm) must have received and failed Bruton tyrosine kinase inhibitor (BTKi) treatment or have been deemed ineligible for BTKi therapy.
Prior therapy with Bruton's tyrosine kinase (BTK) inhibitor
Subjects may have received up to three prior systemic anticancer treatment regimens for adenocarcinoma of the lung (including adjuvant therapies and tyrosine-kinase inhibitors [TKI]), unless discussed with the sponsor.
Last chemotherapy or treatment with another systemic anti-cancer agent must have stopped >= 4 weeks prior to enrollment (or >= 5 half-lives for oral tyrosine-kinase inhibitors); participants with EGFR mutations and ALK gene rearrangement who have not received a tyrosine kinase inhibitor targeting their molecular abnormality (e.g., erlotinib or crizotinib respectively); participants must have recovered (CTCAE =< 1) from acute toxicities of any previous therapy (with the exception of alopecia)
After failure of 2nd line treatment with up to two prior lines of therapy, one of which may be an oral tyrosine kinase inhibitor (TKI)
Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol with the exception of intrathecal chemotherapy; this includes the tyrosine kinase inhibitor sorafenib which must not be initiated until patient demonstrates count recovery
Patient has received a minimum of 3 years of tyrosine kinase inhibitor treatment (first with imatinib (> 4 weeks) and then switched to nilotinib) since initial diagnosis
Prior therapy with other tyrosine kinase inhibitors (TKI) inhibitors or any other type of investigational agent is allowed if it was an adjunct to definitive local therapy, was given for =< 6 months, and was completed at least 12 months before initiating therapy for metastatic disease
Previous treatment with any other tyrosine kinase inhibitor
Chronic myelogenous leukemia who have failed second generation (2G)-tyrosine kinase inhibitors (TKI)
The addition of cytotoxic agents for “cytoreduction” with the exception of tyrosine kinase inhibitors (such as imatinib), cytokine therapy, hydroxyurea, low dose cytarabine, chlorambucil, or Rituxan will not be allowed within three weeks of the initiation of conditioning
Previously treated with and developed resistance or intolerance to dasatinib or nilotinib OR developed the T3151 mutation after any tyrosine kinase inhibitor (TKI) therapy
Patients with CML must have demonstrated resistance and/or intolerance to therapy with at least 2 tyrosine kinase inhibitors (TKI)
Previous treatment with lapatinib, neratinib, afatinib, tucatinib, or other investigational EGFR family receptor tyrosine kinase inhibitor or HER2 tyrosine kinase inhibitor
No evidence of exon 20 T790M mutation after progression on prior EGFR tyrosine kinase inhibitor(TKI) therapy.
No prior treatment with an EGFR tyrosine kinase inhibitor (TKI)
Prior investigational therapy with an agent that is known or proposed to be active by action on any component of the EGFR tyrosine kinase, IGF1R, mTOR, or c-MET pathways
Patients who have received any targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their epithelial ovarian or peritoneal primary cancer.
Liver function tests (LFTs) (bilirubin, AST, and/or ALT) may be acceptable if the elevation is secondary to leukemia infiltration or leukemia therapy with tyrosine kinase inhibitors
The addition of cytotoxic agents for 'cytoreduction' with the exception of tyrosine kinase inhibitors (such as imatinib mesylate), cytokine therapy, hydroxyurea, low dose cytarabine, chlorambucil, or rituxan will not be allowed within three weeks of the initiation of conditioning
Has received prior therapy with imatinib or another tyrosine kinase inhibitor
Ph+ B-ALL if subjects are intolerant to or ineligible for tyrosine kinase inhibitor (TKI) therapy, or have progressed after at least one line of TKI therapy
Subject has received treatment with any other agent with antitumor activity including chemotherapy, radiotherapy, or immunotherapy within 14 days as well as EGFR tyrosine kinase inhibitor within 6 days prior to first dose of study drug.
Prior exposure to dasatinib (> 7 days), Bruton’s tyrosine kinase inhibitor exposure, or prior chemotherapy for ALL (up to 7 days of steroids are allowed)
Subject has received prior treatment with any EGFR tyrosine kinase inhibitor
Prior therapy with hydroxyurea, chemotherapy, biological or targeted therapy (e.g. fms-related tyrosine kinase 3 [FLT3] inhibitors, other kinase inhibitors), or hematopoietic growth factors is allowed
Chemotherapy, hormonal therapy, radiotherapy (except for brain and extremities) or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks prior to treatment with the trial drug
Patients with advanced phase CML or acute leukemia must have failed at least one prior TKI; patients with chronic phase CML must have failed, have resistance or suboptimal response to at least two tyrosine kinase inhibitors, or have intolerance to two prior tyrosine kinase inhibitors; for patients with prior intolerance, they should have received at least 2 TKI and experienced intolerance to one TKI and resistance/suboptimal, a. failure to tyrosine kinase inhibitors will be defined per European-Leukemia-Net (ELN) recommendations, b. resistance or suboptimal response to at least two prior Abl-kinase inhibitor, specifically: i. chronic-phase with resistance to imatinib, dasatinib, nilotinib, bosutinib or ponatinib defined as 1. loss of complete cytogenetic response (CCyR) at any time or failure to achieve CCyR after >= 18 months, 2. loss of major cytogenetic response (MCyR) at any time or failure to achieve partial cytogenetic response (PCyR) after >= 12 months, 3. failure to achieve any cytogenetic response (CyR) (ie, >= 65% Philadelphia chromosome [Ph]+) after >= 6 months, 4. hematologic relapse or failure to achieve complete hematologic response (CHR) after >= 3 months, ii. chronic-phase with suboptimal response to imatinib, defined as 1. failure to achieve PCyR after >= 6 months, 2. failure to achieve CCyR after >= 12 months, iii. chronic-phase with suboptimal response to nilotinib, bosutinib, dasatinib or ponatinib, defined as 1. failure to achieve PCyR after >= 3 months, 2. failure to achieve CCyR after >= 6 months of therapy
Must have relapsed/refractory disease after receiving 1 or more lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor (eg ibrutinib) if approved by the local health authority and commercially accessible. All Arms:
Prior exposure to VEGFR tyrosine kinase inhibitor (small molecule or antibody) or VEGFR antibody.
Tyrosine Kinase Inhibitor (TKI) within 2 weeks.
Has, at the initiation of study drug, received cytotoxic chemotherapy or a Bruton's tyrosine kinase (BTK)-inhibitor (e.g. ibrutinib) within the past 3 weeks or rituximab within the past 2 months
Prior treatment with a spleen tyrosine kinase (SYK) inhibitor
Prior exposure to bruton tyrosine kinase (BTK) inhibitor
Received erlotinib or other EGFR tyrosine kinase inhibitor (TKI) treatment for at least 2 weeks prior to enrollment
Relapsed or refractory to at least one second generation tyrosine kinase inhibitor (TKI) (dasatinib, nilotinib, bosutinib, ponatinib)
No more than one prior line of antitumor therapy for metastatic disease, excluding prior treatment with tyrosine kinase inhibitors. An interval of at least 1 week is required for washout of the tyrosine kinase inhibitor.
Receipt of any prior cytotoxic chemotherapy for ALK-positive NSCLC within 4 weeks prior to Day 1. Patients who received crizotinib or any other tyrosine kinase inhibitors need to have a minimum 2-week washout period before the first dose
The last dose of anti-VEGF tyrosine kinase inhibitor must be at least 7-days but not more than 56-days from enrollment
Must be 14 days from administration of non-cytotoxic agents (e.g., bevacizumab (except COHORT 2b), interferon, tamoxifen, thalidomide, cis-retinoic acid, tyrosine kinase inhibitor, etc.).
Patients are allowed prior VEGFR-tyrosine kinase inhibitor (TKI); patients will be stratified based on prior VEGFR-TKI therapy
Currently or previously treated with AMG 386, or other molecules that primarily inhibit the angiopoietins or TEK tyrosine kinase, endothelial (Tie2) receptor
Any number of prior treatment regimens, including treatment naive subjects. Prior treatment with tyrosine kinase inhibitors is permitted.
Progressive disease after 1-2 prior VEGF-directed tyrosine kinase inhibitors (TKIs).
Chemotherapy, hormone therapy, immunotherapy with monoclonal antibodies, treatment with tyrosine kinase inhibitors, or radiotherapy (except for treatment of extremities) within the past four weeks prior to treatment with the trial drug, i.e., the minimum time elapsed since the last anticancer therapy and the first administration of BIBF 1120 must be four weeks
Either treatment naive to, relapsed/refractory to, or experienced treatment failure due to other reasons with ibrutinib, idelalisib, or any other investigational B-cell receptor (BCR) pathway inhibitors not directly targeting spleen tyrosine kinase (SYK).
Patients who have received or will receive medication that could affect their hematologic state (tyrosine kinase inhibitors, cytotoxic chemotherapy)
GIST patients with iron deficiency anemia (IDA) planned to start or are receiving systemic therapy with tyrosine kinase inhibitors (TKIs)
Be on same oral tyrosine kinase inhibitor (TKI) for >= 3 months
Prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor
Currently in remission and not on any active anti-cancer therapies (survivors receiving maintenance tyrosine kinase inhibitors are NOT eligible).
Participants who were taking EGFR tyrosine kinase inhibitors within 3 months of study entry
Targeted agents including small-molecule tyrosine kinase inhibitors: 2 weeks
Prior exposure to approved receptor tyrosine kinase inhibitors is permitted; at least 5 half-lives must have elapsed since the completion of the kinase inhibitor and the initiation of study treatment
Targeted agents, including small-molecular tyrosine kinase inhibitors: 2 weeks
Planned post-transplant therapy, including use of tyrosine-kinase inhibitors (TKI).
Concurrent administration of lapatinib or other tyrosine kinase inhibitors other than sorafenib
Subjects who have received dasatinib beyond first or second line treatment and meet other enrollment criteria are eligible for the study provided prior Tyrosine-kinase inhibitors (TKI) were discontinued due to intolerance or lack efficacy, although only one instance of lack of efficacy to TKI is allowed.
The patient has either failed, demonstrated intolerance, or a combination of prior failure and intolerance, to prior treatments with at least 2 tyrosine kinase inhibitors (TKI's). Failure of TKI treatment may either be primary (never achieved a response) or secondary resistance (loss of response).
CML in blast phase, resistant or intolerant to tyrosine kinase inhibitor therapy
Patients with EGFR and ALK alterations should have been treated with at least 1 line of targeted tyrosine kinase inhibitor
Has had prior chemotherapy, within 2 weeks prior to study treatment; patients on targeted therapy (tyrosine kinase inhibitor) may go on the study after 5 days off therapy