For patients with platelets > 100,000 cells/ul (100x10^9/L) able to take aspirin daily as prophylactic anticoagulation therapy for ARMS 2+3 (patients intolerant to aspirin may use warfarin, low-molecular-weight heparin or equivalent anti-platelet therapy)
Patients who are not already on anticoagulation should be able to take low-dose aspirin (81 mg) daily; NOTE: if aspirin is contraindicated for other reasons, the patient may be considered for the study after consultation with the study chair regarding other alternatives including possible use of warfarin or low molecular weight heparin; patients unable to take any form of prophylaxis are not eligible
Able to take a minimum dose of aspirin 81 mg daily as prophylactic anticoagulation if not on warfarin, low molecular weight heparin or oral factor Xa inhibitor; patients intolerant to acetylsalicylic acid (ASA) may use warfarin or low molecular weight heparin at doses designed to treat deep venous thrombosis
Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program; able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin [ASA] may use low molecular weight heparin or equivalent)
Able to take aspirin 81 mg orally daily or if intolerant of aspirin, able to take a substitute thromboprophylaxis such as low molecular weight heparin
Able to take aspirin 81 mg daily or if intolerant of aspirin, able to take a substitute thromboprophylaxis such as low molecular weight heparin at a thromboprophylactic dose (such as enoxaparin 0.5 mg/kg once daily)
Able to take aspirin (81 mg) daily or alternative therapy as prophylactic anticoagulation
Willing and able to take aspirin (81 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
Able to take aspirin (81 or 325 mg) daily for prophylactic anticoagulation (patients intolerant to acetylsalicylic acid, ASA, may use warfarin or low molecular weight heparin or other anticoagulants deemed appropriate by the principal investigator [PI])
For patients with bulky disease (tumors > 5 cm); must be able to take aspirin (81 mg or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program; able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin)
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (subjects intolerant to aspirin may use warfarin or low molecular weight heparin) if clinically indicated
Able to take aspirin 81 mg daily or if intolerant of aspirin, able to take a substitute thromboprophylaxis such as low molecular weight heparin at a thromboprophylactic dose (such as enoxaparin 0.5 mg/kg once daily)
Able to take aspirin (81 and 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin [ASA] may use warfarin or low molecular weight heparin)
Subject is able to take prophylactic anticoagulation as detailed in section 9.1 (patients intolerant to aspirin may use warfarin or low molecular weight heparin).
Current or recent (within 10 days prior to first dose of bevacizumab) use of aspirin (> 325 mg/day); prophylactic and therapeutic use of anticoagulants is allowed, e.g., warfarin (1 mg once daily [QD]) for catheter prophylaxis and prophylactic low molecular weight heparin (i.e., enoxaparin [40 mg QD])
Must be able to take acetylsalicylic acid (ASA) daily as prophylactic anticoagulation; patients intolerant to ASA may use low molecular weight heparin or equivalent; warfarin will be allowed provided patient is full anticoagulated, with an international normalized ratio (INR) of 2-3
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or heparin)
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
Patient must be able and willing to receive anticoagulation therapy with aspirin 70-325 mg daily prophylaxis, low molecular weight heparin, factor X inhibitors or warfarin; patients unable or unwilling to take any prophylaxis are NOT eligible
Must be able to take low-dose aspirin, low molecular weight heparin, or other equivalent antithrombotic or anticoagulant daily as prophylactic anticoagulation.
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use low molecular weight heparin)
Low dose aspirin (? 100 mg daily).
If currently not on anticoagulation medication, willing and able to take aspirin (81 or 325 mg) daily; if aspirin is contraindicated, the patient may be considered for the study if on therapeutic dose warfarin or low molecular weight heparin; patients unable to take any prophylaxis are not eligible
If needed, patients should be able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation
Systemic anticoagulation or daily aspirin dose exceeding 325 mg per day
Able to take aspirin, or warfarin, or low molecular weight heparin as prophylactic anticoagulation
Must be able to take acetylsalicylic acid (ASA) (81 or 325 mg) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended. Coumadin will be allowed provided the patient is fully anticoagulated, with an international normalized ratio (INR) of 2 to 3
Must be able to take concurrent aspirin 70mg to 325 mg daily (or enoxaparin if aspirin allergic)
Concurrent use of aspirin > 100 mg daily
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin), unless baseline prothrombin time (PT) or partial thromboplastin time (PTT) is >= 1.5 ULN, in which case thromboprophylaxis is not required
Able to take acetylsalicylic acid (ASA) (81 or 325 mg) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended. Coumadin will be allowed provided the patient is fully anticoagulated, with an INR of 2 or 3.
Must have been able to take concurrent aspirin 81 to 325 mg daily (or enoxaparin 40 mg subcutaneously daily [or its equivalent] if allergic to aspirin), per published standard or institutional standard of care, as prophylactic anticoagulation. NOTE: For participants with prior history of deep vein thrombosis (DVT), low-molecular-weight heparin (LMWH) was mandatory.
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin may use warfarin or low molecular weight heparin)
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin [ASA] may use warfarin or low molecular weight heparin)
Use of 81-100 mg daily aspirin or up to 700 mg aspirin not more than once a week are eligible.
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended. Coumadin will be allowed provided the patient is fully anticoagulate with INR 2.0 to 2.5.
Patient must be able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin) if no additional risk factor for venous thromboembolism (VTE) other than myeloma diagnosis according to International Myeloma Working Group (IMW) guidelines
Able to take aspirin (81 or 325mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin)
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (subjects intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
Able to take aspirin 81 mg daily
Able to take aspirin 325 mg or 81 mg daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use Coumadin or low molecular weight heparin)
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
Use of aspirin is NOT an exclusion criterion as long as the daily dose does not exceed 325 mg daily; initiation of ADAPT therapy requires patient to discontinue aspirin for 18 months
Patients must be able to take daily prophylactic anticoagulation medication, such as: aspirin (81 or 325 mg) warfarin, low molecular weight heparin, or other medications as clinically indicated
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant of aspirin or at increased risk of venous thrombosis may use warfarin or low molecular weight heparin)
Must be able to take concurrent aspirin 325 mg daily
Able to receive prophylactic anticoagulation with aspirin, warfarin or low molecular weight heparin when required for lenalidomide administration
Able to take aspirin daily as prophylactic anticoagulation therapy (subjects intolerant to aspirin may use warfarin or low-molecular-weight heparin).
If currently not on anticoagulation medication, willing and able to take aspirin (325 mg) daily; note: if aspirin is contraindicated, the patient may be considered for the study after if on therapeutic dose warfarin or low molecular weight heparin; patients unable to take any prophylaxis are not eligible
Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program; able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
Use of heparin or acetylsalicylic acid (ASA)
Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
Patient is currently receiving warfarin or other coumadin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed as long as patient has adequate coagulation defined as: activated partial thromboplastin time (aPTT) international normalized ratio (INR) =< 1.5 x upper limit of normal
Participants may not be currently receiving anticoagulation with coumadin for treatment or prophylaxis; therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed
Currently receiving warfarin or other warfarin-derived anticoagulant for treatment, prophylaxis or otherwise; Note: Therapy with heparin, direct oral anticoagulants, low molecular weight heparin (LMWH) or fondaparinux is allowed
Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
Patient is currently receiving warfarin or other Coumadin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, direct thrombin inhibitors, low molecular weight heparin (LMWH) or fondaparinux is allowed
Patient is currently receiving warfarin or other coumadin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
for subjects receiving anticoagulant, the subjects must, in the investigator's opinion, be clinically stable with no evidence of active bleeding while receiving anticoagulant therapy. The INR for subjects on warfarin should be in the therapeutic range. Low molecular weight heparin (LMWH) is allowed.
Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH), fondaparinux, or other oral anticoagulants is allowed
OR for subjects receiving warfarin or low molecular weight heparin (LMWH), the subjects must, in the Investigator's opinion, be clinically stable with no evidence of active bleeding while receiving anticoagulant therapy. The INR for these subjects may exceed 1.5 × ULN if that is the goal of anticoagulant therapy.
Subject is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed.
Patient is currently receiving warfarin or other coumadin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
Receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first dose of study drug
International normalized ratio (INR) =< 1.5\r\n* Use of rivaroxaban, apixaban, edoxaban or warfarin is an exclusion criteria; therapy with heparin, low molecular weight heparin (LMWH), dabigatran or fondaparinux is allowed
Currently receiving rivaroxaban, apixaban, endoxaban, warfarin or other warfarin derived anticoagulant; therapy with heparin, low molecular weight heparin (LMWH), dabigatran or fondaparinux is allowed; if transitioning from a prohibited anticoagulant, a minimum washout of 7 days from last dose of the prohibited medication is required prior to ribociclib start
Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
administration of therapeutic doses of LMWH, fondaparinux, or unfractionated heparin (UFH) for more than 72 hours before randomization;
Patient is currently receiving warfarin or other Coumarin-derived anticoagulant for treatment, prophylaxis, or other reasons. Therapy with heparin, low molecular weight heparin, or fondaparinux is allowed.
Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed
Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed
Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
Subject is currently receiving warfarin or other coumarin-derived anti-coagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed
Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed
Subject is currently receiving warfarin or other Coumarin derived anti-coagulant for treatment; therapy with heparin, low molecular weight heparin (LMWH), factor Xa, or fondaparinux is allowed
Patient is currently receiving warfarin or other Coumarin-derived anticoagulant for treatment, prophylaxis or otherwise; NOTE: therapy with apixaban, dabigatran, heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
Patient is currently receiving warfarin or other coumadin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed.
Patient is currently receiving warfarin or other vitamin K antagonist; therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed
Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed
The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first dose of study drug
Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed
OR for subjects receiving warfarin or low molecular weight heparin (LMWH), the subjects must, in the Investigator's opinion, be clinically stable with no evidence of active bleeding while receiving anticoagulant therapy. The INR for these subjects may exceed 1.5 × ULN if that is the goal of anticoagulant therapy.
Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed.
Patient is currently receiving warfarin or other Coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise; therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed
No concurrent anticoagulation with warfarin or heparin/heparin analogues, clopidogrel, oral direct thrombin inhibitors, or direct factor XA inhibitors
No concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, low molecular weight heparin (LMWH), thrombin or factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); (low dose aspirin [=< 81 mg/day] and prophylactic LMWH are permitted)
No concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel); allowed anticoagulants are the following:\r\n* Low-dose aspirin for cardioprotection (per local applicable guidelines) is permitted\r\n* Low molecular weight heparins (LMWH) or unfractionated heparin is permitted\r\n* Anticoagulation with therapeutic doses of LMWH is allowed in subjects without known brain metastases who are on a stable dose of LMWH for at least 6 weeks before first dose of study treatment, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor
Concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin, and Factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel) are prohibited\r\n* Note: Low-dose aspirin for cardioprotection (per local applicable guidelines) and low dose, low molecular weight heparins (LMWH) are permitted; anticoagulation with therapeutic doses of LMWH is allowed in subjects without radiographic evidence of brain metastasis, who are on a stable dose of LMWH for at least 6 weeks before first dose of study treatment, and who have had no complications from a thromboembolic event or the anticoagulation regimen
Subjects on active anticoagulation therapy including warfarin, factor Xa inhibitors, thrombin inhibitors, or heparin.
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
Concomitant anticoagulation at therapeutic doses with oral anticoagulants (eg, warfarin, direct thrombin and factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel)\r\n* Note: Low-dose aspirin for cardioprotection (per local applicable guidelines), low-dose warfarin (< 1 mg/day), and low dose, low molecular weight heparins (LMWH) are permitted. Anticoagulation with therapeutic doses of LMWH is allowed in subjects without radiographic evidence of brain metastasis, who are on a stable dose of LMWH for at least 12 weeks before randomization, and who have had no complications from a thromboembolic event or the anticoagulation regimen
The participant requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor xabans (Xa) inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
Subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin-related agents, thrombin or FXa inhibitors, or antiplatelet agents (eg, clopidogrel). Low-dose aspirin (?81 mg/day), low-dose warfarin (?1 mg/day), and prophylactic low molecular weight heparin are permitted.
Warfarin use, even if low dose warfarin is not acceptable; however, other anti-coagulants (e.g. aspirin, enoxaparin and heparin derivatives, thrombin inhibitors, etc) are acceptable
Concomitant Medications\r\n* Other planned concurrent investigational agents or other tumor directed therapies (chemotherapy, radiation) are not allowed while on this study\r\n* Concurrent use of somatostatin analogs while on cabozantinib/placebo is allowed provided that the patient has been on a stable dose for at least two months\r\n* Full dose oral anticoagulation/antiplatelet therapy is not permitted; low dose aspirin =< 81 mg/day is allowed; anticoagulation with therapeutic doses of low molecular weight heparin (LMWH) is allowed in patients who are on a stable dose of LMWH for at least 6 weeks prior to registration; treatment with warfarin is not allowed; anticoagulation in patients with brain metastases is not permitted\r\n* Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed; patients must discontinue the drug at least 14 days prior to registration on the study\r\n* Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug at least 14 days prior to the start of study treatment
Concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin and Factor Xa inhibitors), platelet inhibitors (e.g., clopidogrel) or therapeutic doses of low molecular weight heparins (LMWH). Low dose aspirin for cardioprotection (per local applicable guidelines) and low-dose LMWH are permitted. Anticoagulation with therapeutic doses of LMWH is allowed in subjects who are on a stable dose of LMWH for at least 6 weeks before the first dose of study treatment, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
Thromboembolic events requiring therapeutic anticoagulation; concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin and factor Xa inhibitors), platelet inhibitors (e.g., clopidogrel) are prohibited\r\n* Note: Low-dose aspirin for cardioprotection (per local applicable guidelines) and low-dose low-molecular-weight heparin (LMWH) are permitted (in subjects who are on a stable dose of LMWH for at least 6 weeks before the first dose of study treatment, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor)\r\n* Note: Subjects with a venous filter (e.g. vena cava filter) are not eligible for this study
Current use of anticoagulants (warfarin, heparin, direct thrombin inhibitors) at therapeutic levels.
Concomitant anticoagulation at therapeutic doses with oral anticoagulants (eg, warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel);\r\n* Note: Low-dose aspirin for cardioprotection (per local applicable guidelines), low-dose warfarin (< 1 mg/day), and low dose, low molecular weight heparins (LMWH) are permitted; anticoagulation with therapeutic doses of LMWH is allowed in subjects without radiographic evidence of brain metastasis, who are on a stable dose of LMWH for at least 12 weeks before randomization, and who have had no complications from a thromboembolic event or the anticoagulation regimen
Has prothrombin time (PT) or aPTT >1.5× upper limit of normal (ULN) or active uncontrolled coagulopathy or bleeding disorder. Participants therapeutically anticoagulated with warfarin, direct thrombin inhibitors, direct factor Xa inhibitors, or heparin are excluded from enrollment.
Concomitant anticoagulation at therapeutic doses with oral anticoagulants (e.g., warfarin, direct thrombin and factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel)\r\n* Note: Low-dose aspirin for cardioprotection (per local applicable guidelines) and low dose low molecular weight heparin (LMWH) are permitted; anticoagulation with therapeutic doses of LMWH is allowed in subjects who are on a stable dose of LMWH for at least 6 weeks before first dose of study treatment, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor
Concomitant anticoagulation at therapeutic doses with oral anticoagulants (eg, warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel)\r\n* Note: low-dose aspirin for cardioprotection (per local applicable guidelines), low-dose warfarin (< 1 mg/day), and low dose, low molecular weight heparins (LMWH) are permitted if started > 6 months prior to randomization; LMWH used as therapeutic anticoagulation may increase observed PTT levels in subjects; anticoagulation with therapeutic doses of LMWH is allowed in subjects without radiographic evidence of brain metastasis, who are on a stable dose of LMWH for at least 24 weeks before randomization, and who have had no complications from a thromboembolic event or the anticoagulation regimen
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or Factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
Patients requiring concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors, antiplatelet agents (e.g. clopidogrel) or new oral anticoagulants; low-dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
Warfarin is not permitted; prophylactic or therapeutic use of low molecular-weight heparin (e.g., enoxaparin) or direct thrombin inhibitors are permitted
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or Factor Xa inhibitors, or antiplatelet agents (eg, clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
Current use of anticoagulants (warfarin, heparin, direct thrombin inhibitors) at therapeutic levels
The subject is receiving concomitant treatment with warfarin, warfarin-related agents, or low molecular weight heparin (LMWH) at the time of study entry at therapeutic doses; low-dose warfarin (=< 1 mg/day) or LMWH at prophylactic doses are permitted
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors, or antiplatelet agents (e.g. clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
Concomitant anticoagulation at therapeutic doses with oral anticoagulants (eg, warfarin, direct thrombin and factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel)\r\n* Note: Low-dose aspirin for cardioprotection (per local applicable guidelines), low-dose warfarin (< 1 mg/day), and low dose, low molecular weight heparins (LMWH) are permitted; anticoagulation with therapeutic doses of LMWH is allowed in subjects who are on a stable dose of LMWH for at least 6 weeks before first dose of study treatment, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor
Therapeutic-dose anticoagulation (e.g., warfarin, low-molecular weight heparin [LMWH], or novel oral anticoagulants) must be discontinued and coagulation parameters must be normalized prior to the first dose of abiraterone/enzalutimide. Prophylactic anticoagulation, with low doses (per standard practice) of agents such as low molecular weight heparin (LMWH), direct thrombin inhibitors, or factor Xa inhibitors is permitted.
Patients may not be on warfarin, factor Xa inhibitors and direct thrombin inhibitors; Note: low molecular weight heparin and prophylactic low dose warfarin are permitted; APTT/PTT must meet the inclusion criteria; subjects taking warfarin must have their international normalized ratio (INR) followed closely
Therapeutic anticoagulation with warfarin, antiplatelet agents (e.g., clopidogrel), thrombin, or Factor Xa inhibitors is not allowed; therapeutic anticoagulation with low molecular weight heparin (LMWH) is allowed as well as prophylactic anticoagulation using low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and LMWH
Current use of warfarin, factor Xa inhibitors and direct thrombin inhibitors; Note: low molecular weight heparin and prophylactic low dose warfarin are permitted; PT/PTT must meet the inclusion criteria; subjects taking warfarin must have their INR followed closely
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or coumadin-related agents, thrombin or factor Xa (FXa) inhibitors, and antiplatelet agents (eg, clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted; therapeutic anticoagulation with LMWHs may be allowed in certain circumstances as outlined
No concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted; please note that drugs that strongly induce or inhibit cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) or are associated with a risk of Torsades are not allowed; chronic concomitant treatment of CYP3A4 inducers is not allowed (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John’s wort); as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product; the following drugs are strong inhibitors of CYP3A4 and are not allowed during the treatment with cabozantinib: \r\n* Boceprevir\r\n* Indinavir\r\n* Nelfinavir\r\n* Lopinavir/ritonavir\r\n* Saquinavir\r\n* Telaprevir\r\n* Ritonavir\r\n* Clarithromycin\r\n* Conivaptan\r\n* Itraconazole\r\n* Ketoconazole\r\n* Mibefradil\r\n* Nefazodone \r\n* Posaconazole\r\n* Voriconazole\r\n* Telithromycin\r\n* Drugs with possible or conditional risk of torsades should be used with caution knowing that cabozantinib could prolong the QT interval
Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin, and factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel); Note: low-dose aspirin for cardioprotection (per local applicable guidelines) and low dose, low molecular weight heparins (LMWH) are permitted; anticoagulation with therapeutic doses of LMWH is allowed in subjects without radiographic evidence of brain metastasis, who are on a stable dose of LMWH for at least 6 weeks before the first dose of study treatment, and who have had no complications from a thromboembolic event or the anticoagulation regimen
Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin, and factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel); note: low-dose aspirin for cardioprotection (per local applicable guidelines) and low dose, low molecular weight heparins (LMWH) are permitted; anticoagulation with therapeutic doses of LMWH is allowed in subjects without radiographic evidence of brain metastasis, who are on a stable dose of LMWH for at least 6 weeks before the first dose of study treatment, and who have had no complications from a thromboembolic event or the anticoagulation regimen
Current use or anticipated need for treatment with Coumadin® or other agents containing warfarin (except low dose Coumadin [1 mg or less daily] administered prophylactically for maintenance of in-dwelling lines or ports); heparin, low molecular weight heparin (LWMH), direct thrombin inhibitors and factor Xa inhibitors are allowed; rivaroxaban should be used with caution; antiplatelet agents are allowed
The subject requires treatment, in therapeutic doses, with oral anticoagulants such as warfarin prior to initiation of protocol therapy; low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and low molecular weight heparin (LMWH) are permitted; subjects will be permitted to use anticoagulation if treatment is required while they are enrolled on the protocol
For patients requiring anti-coagulation therapy, only therapeutic low molecular weight heparin, direct thrombin inhibitors, or factor Xa inhibitors are permitted
Current use of warfarin, factor Xa inhibitors and direct thrombin inhibitors\r\n* Note: Low molecular weight heparin and prophylactic low dose warfarin are permitted; PT/PTT must meet the inclusion criteria; subjects taking warfarin must have their INR followed closely
Use of warfarin is prohibited; anticoagulation with low-molecular weight heparin (i.e. enoxaparin) or direct thrombin inhibitors is permitted
Current use of anticoagulants (warfarin, heparin, direct thrombin inhibitors) at therapeutic levels
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
No concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or Factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted; please note that drugs that strongly induce or inhibit cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or are associated with a risk of torsades are not allowed; chronic concomitant treatment of CYP3A4 inducers is not allowed (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St. John’s wort); as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product; the following drugs are strong inhibitors of CYP3A4 and are not allowed during the treatment with sorafenib:\r\n* Boceprevir\r\n* Indinavir\r\n* Nelfinavir\r\n* Lopinavir/ritonavir\r\n* Saquinavir\r\n* Telaprevir\r\n* Ritonavir\r\n* Clarithromycin\r\n* Conivaptan\r\n* Itraconazole\r\n* Ketoconazole\r\n* Mibefradil\r\n* Nefazodone\r\n* Posaconazole\r\n* Voriconazole\r\n* Telithromycin\r\n** Drugs with possible or conditional risk of torsades should be used with caution knowing that sorafenib could prolong the QT interval
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or Factor Xa inhibitors, or antiplatelet agents (eg, clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
The participant requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa (FXa) inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or Coumadin-related agents, heparin, thrombin or factor Xa (FXa) inhibitors, and antiplatelet agents (eg, clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
Clinically significant bleeding within 4 weeks of screening, current use of warfarin, factor Xa inhibitors, and direct thrombin inhibitors unless these medications can be safely discontinued 14 days prior to AMG-232 administration; Note: low molecular weight heparin and prophylactic low dose warfarin are permitted; PT/PTT must meet the inclusion criteria; subjects taking warfarin must have their INR followed closely
Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon), direct thrombin inhibitors, direct factor Xa inhibitors or heparin or low-molecular weight heparins at therapeutic doses
Use of warfarin, factor Xa inhibitors, or direct thrombin inhibitors
Patients on warfarin will not be allowed on the study; patient on low molecular heparin or anti direct factor Xa inhibitor (Xa) drugs will be allowed
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or Factor Xa inhibitors, or antiplatelet agents (eg, clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, thrombin or factor Xa inhibitors; aspirin (up to 325 mg/day), low-dose warfarin (=< 1 mg/day), prophylactic and therapeutic low molecular weight heparin (LMWH) are permitted
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or Coumadin-related agents, thrombin or factor Xa (FXa) inhibitors, and antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted; therapeutic anticoagulation with LMWHs may be allowed in certain circumstances
Ongoing need for therapeutic anticoagulants (full dose heparin, warfarin, factor Xa or direct thrombin inhibitors; rivaroxaban, apixaban, dabigatran) chronic use of aspirin or anti-platelet agents (ticlopidine or clopidogrel)
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day) and prophylactic low molecular weight heparin (LMWH) are permitted
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted (please note that there may be cases in which patients on study require anticoagulation for deep vein thrombosis [DVT]/pulmonary embolism [PE] management; this does not necessitate taking the patient off study)
The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor xabans (Xa) inhibitors, or antiplatelet agents (eg, clopidogrel); low dose aspirin (=< 100 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
Currently receiving antiplatelet therapy of prasugrel or clopidogrel, or full dose anticoagulation treatment with therapeutic doses of warfarin; Note: treatment with low doses of warfarin (e.g., =< 2 mg/day ) for line patency allowed; also, low molecular weight heparins, fondaparinux, antiaggregation agents (e.g., eptifibatide, epoprostenol, dipyridamole) or locally accepted low doses of acetylsalicylic acid (up to 100 mg daily) may be administered concomitantly with dovitinib with caution
Current or recent use of dipyridamole, ticlopidine, clopidogrel, cilostazol is excluded; aspirin (=< 325 mg per day) is allowed; prophylactic anticoagulation with oral or parenteral anticoagulants for the patency of venous access devices or other indications is allowed, therapeutic use of low-molecular weight heparin (such as enoxaparin), and factor Xa inhibitors are allowed; use of warfarin is prohibited
Inability to stop anticoagulants (e.g., heparin, Warfarin) or antiplatelet agents (e.g. aspirin, clopidogrel) prior to procedure
Ongoing therapy with any anticoagulant or antiplatelet agents (example, aspirin, clopidogrel, heparin, or warfarin).
The patient requires therapeutic doses of any anticoagulant, including LMWH. Concomitant use of warfarin, even at prophylactic doses, is prohibited.
Patients who are currently receiving therapeutic anticoagulants (including aspirin, low molecular weight heparin, and others) are not eligible
Patients must not have evidence of coagulopathy or bleeding diathesis; therapeutic anticoagulation for prior thromboembolic events is permitted; the clinical indication for therapeutic anticoagulation must be clearly documented prior to enrollment and must be discussed with the principal investigator (PI); patients on greater than or equal to 2 anti-thrombotic agents, including but not limited to anti-platelet agents (nonsteroidal anti-inflammatory drugs [NSAIDS]/aspirin, clopidogrel), heparin, low molecular weight heparin, warfarin and a direct thrombin inhibitor will be excluded
Patient must not require the use of full dose coumarin-derivative anticoagulants such as warfarin; low molecular weight heparin is permitted for prophylactic or therapeutic use; factor X inhibitors are permitted\r\n* NOTE: Warfarin may not be started while enrolled in the EAY131 study\r\n* Stopping the anticoagulation for biopsy should be per site standard operating procedure (SOP)
Current necessity for full-dose anticoagulation with warfarin or its equivalent (i.e. unfractionated and/or low molecular weight heparin)
Treatment with anticoagulation with warfarin, low-molecular-weight heparin, or similar agents for therapeutic purposes;
Treatment with systemic anticoagulation (e.g. warfarin, heparin, low molecular weight heparin, anti-Xa inhibitors, etc.) except aspirin
Required concurrent use of anti-coagulants or anti-platelet medication, with the exception of aspirin doses ?81 mg/day, low-dose SC heparin or SC low-molecular-weight heparin for DVT prophylaxis, or heparin flushes to maintain IV catheter patency
Therapeutic anticoagulation is allowed; the participant must be on a stable dose of anticoagulant medication (warfarin, or low molecular weight heparin [LMWH]) prior to study entry
Patients may NOT be on full dose anti-coagulation therapy; maintenance doses of low molecular weight heparin is permissible
Pts must agree to take enteric-coated aspirin 81 mg orally daily, or if history of prior thrombotic disease, must be fully anticoagulated with warfarin (INR 2-3) or be treated with full-dose, low molecular weight heparin, as if to treat deep venous thrombosis (DVT)/pulmonary embolism (PE)at the investigator's discretion
Contraindication to any of the required concomitant drugs, including proton-pump inhibitor (e.g. lansoprazole), enteric-coated aspirin or if a history of prior thrombotic disease, warfarin or low molecular weight heparin
Current and continuing anticoagulation with warfarin sodium (Coumadin, heparin, low-molecular weight heparin, Clopidogrel bisulfate (Plavix),or equivalent. (Unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or for marker placement).
Patients who are on therapeutic anticoagulation with warfarin; patients on therapeutic doses of with low molecular weight heparins are eligible
Participants should not take drugs that directly and durably inhibit coagulation with the exception of warfarin (coumadin) and heparin including low-molecular-weight heparin (LMWH), including enoxaparin, tinzaparin, etc
Patients who require concurrent treatment with antithrombotic and/or anti-platelet agents (e.g., warfarin, heparin, low molecular weight heparin, aspirin, and/or ibuprofen)
Anticoagulation with low-molecular-weight heparin (LMWH) will be permitted; patients receiving treatment with warfarin or any of the new oral anticoagulants (NOACs) (rivaroxaban, apixaban, dabigatran, or edoxaban) will be given the option to switch to LMWH
Patients must not be on therapeutic anticoagulation (Warfarin [coumadin] and/or low molecular weight heparin are prohibited). Prophylactic anticoagulation (i.e. intraluminal heparin) of venous or arterial access devices is allowed.
Patients who are currently receiving therapeutic anti-coagulation with heparin, low-molecular weight heparin or Coumadin are not eligible for this trial
The patient requires therapeutic doses of any anticoagulant, including low molecular weight heparin (LMWH). Concomitant use of warfarin, even at prophylactic doses, is prohibited.
Heparin, warfarin or similar anti-coagulants (except. low molecular weight heparin for treatment/prophylaxis) currently or w/in 4 wks of study drug
Use of anticoagulants (e.g., warfarin, heparin) at therapeutic levels within 7 days prior to the first dose of GSK525762. Low dose (prophylactic) low molecular weight heparin (LMWH) is permitted. In addition, INR must be monitored in accordance with local institutional practices, as appropriate.
If they are on any dose of warfarin or are on full dose anticoagulation with other agents, including low molecular weight heparin, antithrombin agents, antiplatelet agents and full dose aspirin within 7 days prior to first dose of study drug; patients on prophylactic doses of low-molecular weight heparin are allowed
Patients on therapeutic doses of Coumadin (> 1 mg daily); the use of therapeutic or prophylactic low molecular weight heparin or fragmin is permitted
Current and continuing anticoagulation with warfarin sodium (Coumadin), heparin, low- molecular weight heparin, Clopidogrel bisulfate (Plavix), or equivalent (unless it can be stopped to manage treatment related toxicity or to have a biopsy if needed).
Current and continuing anticoagulation with warfarin sodium (coumadin), heparin, low- molecular weight heparin, Clopidogrel bisulfate (plavix), or equivalent (unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or place markers)
Requirement of anticoagulant therapy with oral vitamin K antagonists such as Coumadin (warfarin). Low-dose anticoagulants for the maintenance of patency in a central venous access device or the prevention of deep vein thrombosis or pulmonary embolism is allowed. Therapeutic use of low molecular weight heparin is allowed provided patients are safely able to interrupt it prior to biopsy procedures.
Warfarin (any dose) or full-dose anticoagulation with other agents (low molecular weight heparin, antithrombin agents, anti-platelet agents and full dose aspirin) within 7 days prior to first dose of study drug; patients on prophylactic doses of low-molecular weight heparin are allowed
Patient is using warfarin or any other Coumadin-derivative anticoagulant or vitamin K antagonists or any form of anticoagulation including low molecular weight heparin
Subjects who require therapeutic anticoagulation or anti-platelet therapy\r\n* Low dose aspirin (=< 100 mg/day) is allowed\r\n* Prophylactic doses of low molecular weight heparin (LMWH) are allowed if approved by study chair or designee
Thrombotic disorders or use of anticoagulants, such as warfarin, requiring therapeutic international normalized ratio (INR) monitoring; (treatment with low molecular weight heparin (LMWH) or direct acting oral anti-coagulants is allowed)
Patients receiving anticoagulation or anti-platelet therapy are excluded; excluded agents include heparin or low molecular weight heparin, warfarin, clopidogrel, ibuprofen and other nonsteroidal anti-inflammatory drug (NSAIDS), tirofiban, and other anticoagulants, drugs, or herbal supplements that affect platelet function; administration of heparin to keep subject's infusion lines patent is allowed; low-dose anticoagulation medications that are used to maintain the patency of a central intravenous catheter are allowed; aspirin will not be allowed within 7 days prior to the first dose of navitoclax or during navitoclax administration; however, subjects who have previously received aspirin therapy for thrombosis prevention, may resume a low dose (i.e., maximum 100 mg QD) of aspirin if platelet counts are stable (>= 50,000/mm^3) through 6 weeks of navitoclax administration; all decisions regarding treatment with aspirin therapy will be determined by the investigator in conjunction with the medical monitor
International normalized ratio (INR) =< 1.5; anticoagulation is allowed only with low molecular weight heparin (LMWH); patient receiving LMW heparin on stable therapeutic dose for more than 2 weeks or with factor Xa level < 1.1 U/mL are allowed on the trial
Current anticoagulation therapy with therapeutic doses of warfarin (low-dose warfarin =< 1 mg/day or low molecular-weight heparin are permitted
Patients on coumadin must be willing to switch to an alternative subcutaneous low-molecular-weight heparin (LMWH) or oral agent (at principal investigator [PI] discretion exceptions can be permitted, as determined on a case by case basis and documented)
If patients require anticoagulation while on protocol, they should be switched from warfarin to another alternative anticoagulant such as low molecular weight heparin or oral direct factor Xa inhibitors as deemed appropriate by the treating physician for the duration they are on capecitabine (must be switched at least 1 week prior to starting capecitabine) to avoid drug-drug interaction of warfarin with capecitabine
Subjects must not be on full dose oral anticoagulation such as warfarin. Low dose warfarin and prophylactic as well as therapeutic low molecular weight heparin are allowable.
Patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose
Deep venous thrombosis within 6 months prior to study treatment, unless the patient is anti-coagulated without the use of warfarin for ?2 weeks prior to study treatment; in this situation, low molecular weight heparin is preferred
History of thromboembolic event or other condition currently requiring anticoagulation with warfarin (coumadin); patients who are treated with low molecular weight heparin or fondaparinux are eligible
Patients may not receive Coumadin while on study; patients may receive low molecular weight heparin or novel oral anticoagulants (eg. dabigatran, apixaban, rivaroxaban) provided that the dose is held 1-2 days before injections are given and biopsies are performed per the protocol; anti-platelet agents and herbal substances are allowed at the discretion of the treating endoscopist
Requirement for anti-coagulation with Coumadin, low molecular weight heparin and anti-thrombin inhibitors will be accepted if anticoagulation has been stable for at least 4 weeks and no recent history of prior bleeding complications
Coagulopathy, including the use of Coumadin or heparin anticoagulants that cannot be discontinued for the cryoablation procedure; NOTE: heparin for line patency without detectable lab abnormalities for coagulation will be allowed
Receiving any of the following medications:\r\n* Therapeutic doses of any anticoagulant, including low-molecular weight heparin (LMWH); concomitant use of warfarin, even at prophylactic doses, is prohibited\r\n* Digoxin, digitoxin, lanatoside C, or any type of digitalis alkaloids\r\n* Colony-stimulating factors (CSFs) that cannot be held during the monitoring period for dose-limiting toxicities (DLT)
Patients may not have evidence of coagulopathy or bleeding diathesis; therapeutic anticoagulation for prior thromboembolic events is permitted; the clinical indication for therapeutic anticoagulation must be clearly documented prior to enrollment and must be discussed with the P.I.; patients who are on greater than or equal to 2 anti-thrombotic agents, including but not limited to anti-platelet agents (non-steroidal anti-inflammatory drugs [NSAIDs]/aspirin, clopidogrel), heparin, low molecular weight heparin (LMWH), warfarin, and a direct thrombin inhibitor, will be excluded
Requirement of anticoagulant therapy with oral vitamin K antagonists such as Coumadin (warfarin); low-dose anticoagulants for the maintenance of patency in a central venous access device or the prevention of deep vein thrombosis or pulmonary embolism is allowed; therapeutic use of low molecular weight heparin is allowed
Require therapeutic use of anticoagulants other than daily aspirin or low molecular weight heparin
Bleeding or thrombotic disorders or use of anticoagulants, such as warfarin, or similar agents requiring therapeutic international normalized ration (INR) monitoring; (treatment with low molecular weight heparin [LMWH] is allowed)
Ongoing risk for bleeding due to active peptic ulcer disease or bleeding diathesis or requirement for systemic anticoagulation with unfractionated heparin, low-molecular-weight heparin or heparin fractions (eg, enoxaparin, dalteparin, fondaparinux) or oral anticoagulants (eg, apixaban, rivaroxaban, dabigatran etexilate, warfarin). Note: Use of heparin or thrombolytic agents for local maintenance or clearance of a central venous catheter is permitted.
Subjects receiving any vitamin K antagonists (VKAs) prior to randomization or receiving more than 36 hours treatment with LMW(low molecular weight Heparin) in therapeutic doses prior to randomization;
Requirement for anticoagulation treatment that increases INR or aPTT above the normal range (low molecular weight heparin and heparin line flush allowed).
Participants must agree to ongoing anticoagulation as prophylaxis against deep vein thrombosis (DVT) using aspirin (81 or 325 mg) daily, warfarin or low molecular weight heparin, or a patient already taking another oral anticoagulant (e.g. direct thrombin inhibitors for atrial fibrillation) may continue that agent
Anticoagulation therapy (within 7 days of Study Day 1), except low molecular weight heparins or low dose aspirin.
The patient is receiving therapeutic anticoagulation with warfarin, low molecular weight heparin, or similar agents; patients receiving prophylactic, low-dose anticoagulation therapy are eligible provided that the coagulation parameters defined in the inclusion criteria (INR =< 1.5 or PT =< 1.5 x ULN and PTT/aPTT =< 1.5 x ULN)
Receiving therapeutic anticoagulation (Coumadin or low molecular weight heparin, heparin, apixaban, dabigatran, rivaroxaban, warfarin)
Current use of therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulants; heparin and/or low molecular weight heparins are allowed
Unable to tolerate thromboembolic prophylaxis including, as clinically indicated, aspirin, Coumadin (warfarin) or dose adjusted low-molecular weight heparin
Therapeutic anticoagulation, including but not limited to: low-molecular weight heparin (LMWH), heparin, or warfarin; anticoagulants must be discontinued 10 days prior to the first administration of bevacizumab; prophylactic use of anticoagulants is allowed
Abnormality in coagulation parameters. Received oral or parenteral anticoagulants or thrombolytic agents within 10 days of the first dose of trial drug. Low dose high molecular weight heparin is permitted if international normalized ratio is within the normal range
Patients must not be on any dose of warfarin or are on full dose anticoagulation with other agents, including low molecular weight heparin, antithrombin agents, anti-platelet agents and full dose aspirin within 7 days prior to first dose of study drug; patients on prophylactic doses of low-molecular weight heparin are allowed
Subject is receiving therapeutic anticoagulation therapy; low dose anti-coagulation (e.g., low dose heparin or warfarin) for catheter prophylaxis will be permitted; use of aspirin for treatment of atrial fibrillation will also be permitted
Patients who are currently receiving therapeutic anticoagulants (including aspirin, low molecular weight heparin, and others) are not eligible
Anticoagulants/anti-platelets: patients on therapeutic (treatment) dose of anticoagulants (e.g. warfarin, low molecular-weight heparin) are not eligible; patients are not allowed to take aspirin, clopidogrel, ticlopidine, Aggrenox; patients on prophylactic anticoagulation may be enrolled and treated on study as long as their platelet count is monitored closely and maintained at > 75,000 while they are receiving dasatinib
International normalized ratio (INR): =< 1.5 (patients on warfarin need to be converted to low-molecular-weight heparin [LMWH] during study participation to be eligible)
Patients who are receiving any anti-coagulation or anti-platelet therapy including, but not limited to, Clopidogrel, vitamin K antagonists (e.g. warfarin) , heparin, low molecular weight heparin, dabigatran, rivaroxaban, and apixaban
Concurrent or recent (within 1 month) use of thrombolytic agents, or full-dose anticoagulants (except to maintain patency of preexisting, permanent indwelling IV catheters). Of note, therapy with low-molecular weight heparin is acceptable as long as the INR < 2.0.
Patients requiring use of warfarin for therapeutic purposes; subcutaneous heparin or fractionated heparin products are permitted if the goal is not to achieve full-dose systemic anticoagulation
Currently receiving anticoagulation with therapeutic doses of warfarin (low-molecular weight heparin is permitted)
Patients unable to discontinue anti-platelet or anti-coagulant medicine such as clopidogrel, dabigatran, warfarin, or low molecular weight heparin; use of aspirin is not an exclusion criteria
Patients must agree to take enteric coated aspirin 81 mg orally daily, or if history of prior thrombotic disease, must be fully anticoagulated with warfarin (international normalized ratio [INR] 2-3) or be treated with full dose, low molecular weight heparin, as if to treat deep venous thrombosis (DVT)/pulmonary embolism (PE)
Contraindication to any of the required concomitant drugs, including proton pump inhibitor (e.g. lansoprazole), enteric coated aspirin or if a history of prior thrombotic disease, warfarin or low molecular weight heparin
Patients requiring warfarin therapy are excluded, low molecular weight heparin is permitted
Partial thromboplastin time =< institutional upper limit of normal, unless receiving therapeutic low molecular weight heparin
Requires anticoagulation that cannot be discontinued prior to biopsy\r\n* Note: Exception if able to hold antiplatelet agents 7 days prior to the injections and biopsy\r\n* NOTE: Low molecular weight heparin (LMWH) will be allowed for bridging if on warfarin\r\n* NOTE: Heparin for line patency without detectable lab abnormalities for coagulation will be allowed
Treatment with unfractionated heparin; patients taking an anticoagulant must use warfarin or a low molecular weight heparin
Patient receiving active treatment of anticoagulants (i.e. warfarin, low molecular weight heparins)
If they are on any dose of warfarin or are on full dose anticoagulation with other agents, including low molecular weight heparin, antithrombin agents, anti-platelet agents and full dose aspirin within 7 days prior to first dose of study drug; patients on prophylactic doses of low-molecular weight heparin are allowed
Therapeutic anticoagulation is allowed for patients on a stable dose of warfarin or low molecular weight heparin
Within 14 days prior to registration: Partial thromboplastin time (PTT) =< institution’s ULN, unless receiving therapeutic low molecular weight heparin
Patients may not be on coumarin anti-coagulants (warfarin, etc.); heparin, low-molecular weight heparin (LMWH), or other antithrombotic medications are permitted
Receiving therapeutic anticoagulation (Coumadin or low molecular weight heparin)
TUMOR BIOPSY SEQUENCING: Patients who require use of coumarin-derivative anticoagulants such as warfarin are excluded; low molecular weight heparin is permitted for prophylactic or therapeutic use
TREATMENT: Patients who require use of coumarin-derivative anticoagulants such as warfarin are excluded; low molecular weight heparin is permitted for prophylactic or therapeutic use
Patients receiving anticoagulation or anti-platelet therapy are excluded due to the risk of thrombocytopenia with navitoclax\r\n* Excluded agents include heparin or low molecular weight heparin, warfarin, clopidogrel, ibuprofen and other non-steroidal anti-inflammatory drugs (NSAIDS), tirofiban, and other anticoagulants, drugs, or herbal supplements that affect platelet function\r\n* Administration of heparin to keep subject's infusion lines patent is allowed; low-dose anticoagulation medications that are used to maintain the patency of a central intravenous catheter are allowed\r\n* Aspirin will not be allowed within 7 days prior to the first dose of navitoclax or during navitoclax administration; however, subjects who have previously received aspirin therapy for thrombosis prevention, may resume a low dose (i.e., maximum 100 mg once daily [QD]) of aspirin if platelet counts are stable (>= 50,000/mm3) through 6 weeks of navitoclax administration \r\n* All decisions regarding treatment with aspirin therapy will be determined by the investigator in conjunction with the medical monitor
Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders; patients on anticoagulation with low molecular weight heparin are allowed
Subjects on warfarin. Prophylactic anticoagulation with low molecular weight heparin\n             is allowed
Patients who are currently receiving therapeutic anti-coagulation with heparin, low-molecular weight heparin or Coumadin are not eligible for this trial
Concurrent use of anti-coagulants (warfarin, etc.) other than low-molecular weight heparin (LMWH); medication must be stopped before time of registration; if patient has recently been on anti-coagulants other than LMWH, patient must have international normalized ratio (INR) =< 2
Patients who require use of coumarin-derivative anticoagulants such as warfarin are excluded; low molecular weight heparin is permitted for prophylactic or therapeutic use; low-dose warfarin (=< 1 mg/day) is permitted
Patients requiring chronic anticoagulation with warfarin are excluded; patients treated with low molecular weight heparin or unfractionated heparin are eligible if on a stable dose without evidence of clinically significant bleeding for at least 2 weeks prior to enrollment
Current treatment or treatment within 7 days of screening with a vitamin K\n             antagonist, such as warfarin. Patients who require anticoagulation due to their\n             central line may receive an alternative agent, such as low molecular weight heparin\n             (LMWH).
Oral anticoagulants such as warfarin are cytochrome P450 family 2, subfamily C, polypeptide 9 (CYP2C9) substrates and, as such, no interaction with everolimus is expected; anticoagulation with Coumadin is allowed if target INR is =< 2.0 and stable for > 2 weeks; anticoagulation with low-molecular-weight heparin (LMWH) is allowed
Patients who require heparin (other than low-molecular weight heparin)
Inability to comply with an anti-thrombotic treatment regimen (e.g., administration of aspirin, enoxaparin, or low molecular weight heparin administration [type Innohep or equivalent])
Is unable or unwilling to undergo thromboembolic prophylaxis including, as clinically indicated, aspirin, Coumadin (warfarin) or low-molecular weight heparin.
Inability to comply with an anti-thrombotic treatment regimen (e.g., administration of aspirin, enoxaparin, or low molecular weight heparin administration)
Anti-coagulation therapy. Aspirin, other anti-platelet agents, and low molecular weight heparin are permitted unless the investigator deems the patient is at a significant risk for bleeding.
Required concurrent use of anti-coagulants or anti-platelet medication, with the exception of aspirin doses ?81 mg/day, low-dose SC heparin or SC low-molecular-weight heparin for DVT prophylaxis, or heparin flushes to maintain IV catheter patency
Ongoing treatment with therapeutic doses of warfarin or low molecular weight heparin (low dose warfarin up to 2 mg orally [PO] daily or use of subcutaneous low molecular weight heparin for thromboembolic prophylaxis is allowed)
Participant is currently on medications that interfere with coagulation (including warfarin) or platelet function with the exception of low dose aspirin (up to 100 mg) and Low-molecular-weight heparin.
Anticoagulation/antiplatelet therapy within 7 days of Cycle 1 Day 1, including low molecular weight heparin, or warfarin.
Patients must be able to start low-molecular weight heparin, as prophylaxis
Patients are excluded if they have current, ongoing treatment with full-dose warfarin or its equivalent (i.e., unfractionated and/or low molecular weight heparin); subjects should have not taken full-dose warfarin or equivalent for at least 2 weeks prior to randomization
Current use of anticoagulants (e.g., warfarin, heparin) at therapeutic levels within 7 days prior to the first dose of GSK525762. Low dose (prophylactic) low molecular weight heparin (LMWH) is permitted. In addition, INR must be monitored in accordance with local institutional practices.
Subjects receiving heparin, warfarin, or other similar anticoagulants, except for subjects on low molecular weight heparin for DVT/PE prophylaxis. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.
Patients on Warfarin/Dabigatran/Rivaroxaban anticoagulation may be enrolled for as long as they undergo weekly INR checks for the first 2 months of therapy. a. Patients who switch to low molecular weight heparin may be enrolled and weekly INR labs are not mandated for these patients.
Anticoagulation/antiplatelet therapy within 7 days of C1D1, including acetylsalicylic acid, low molecular weight heparin, or warfarin
patients on anticoagulants for whom temporarily stop and start, supported by low molecular weight heparin (or other anticoagulation therapy at the discretion of the investigator and or per local standard of care) during vaccination and nephrectomy, is not an option
Prophylactic doses of heparin.
The concomitant use of warfarin or other vitamin K antagonists unless felt to be of significant clinical need; low molecular weight heparin or other anticoagulants may be used instead if anticoagulation is required
Use or need for full dose anticoagulation other than low molecular weight heparin and factor Xa inhibitors (e.g. Lovenox, fondaparinux) and no other bleeding risk
Patients currently taking anticoagulants (warfarin, heparin/low molecular weight heparin [e.g., danaparoid, dalteparin, tinzaparin, enoxaparin])
Bleeding or thrombotic disorders or use of anticoagulants requiring therapeutic INR monitoring, eg, warfarin or similar agents. Treatment with low molecular weight heparin and factor X inhibitors which do not require INR monitoring is permitted. Antiplatelet agents are prohibited throughout the study.
Patients must have no medical contra-indications to, and be willing to take, deep vein thrombosis (DVT) prophylaxis as all patients registering to the lenalidomide/rituximab Arms G and H will be required to have deep vein thrombosis (DVT) prophylaxis; patients randomized to Arms G or H who have a history of a thrombotic vascular event will be required to have full anticoagulation, therapeutic doses of low-molecular weight heparin or warfarin to maintain an international normalized ratio (INR) between 2.0-3.0, or any other accepted full anticoagulation regimen (e.g., direct thrombin inhibitors or factor Xa inhibitors) with appropriate monitoring for that agent; patients on Arms G and H without a history of a thromboembolic event are required to take a daily aspirin (81 mg or 325 mg) for DVT prophylaxis; patients who are unable to tolerate aspirin should receive low molecular weight heparin therapy or warfarin treatment or another accepted full anticoagulation regimen
Patients must have no medical contra-indications to, and be willing to take, DVT prophylaxis as all patients registering to the lenalidomide/rituximab Arms G and H will be required to have deep vein thrombosis (DVT) prophylaxis; patients randomized to Arms G or H who have full anticoagulation, a history of a thrombotic vascular event will be required to have therapeutic doses of low molecular weight heparin or warfarin to maintain an INR between 2.0 – 3.0, or any other accepted full anticoagulation regimen (e.g., direct thrombin inhibitors or factor Xa inhibitors) with appropriate monitoring for that agent; patients on Arms G and H without a history of a thromboembolic event are required to take a daily aspirin (81 mg or 325 mg) for DVT prophylaxis; patients who are unable to tolerate aspirin should receive low molecular weight heparin therapy or warfarin treatment or another accepted full anticoagulation regimen
Patients who are currently receiving therapeutic anticoagulants (including aspirin, low molecular weight heparin, warfarin and others) are not eligible
Current therapy with warfarin or other anticoagulants at therapeutic doses, e.g., low molecular weight heparin, fondaparinux, dabigatran, rivaroxaban, apixaban or edoxaban that are unable to be discontinued
Therapeutic anticoagulation (e.g., warfarin, heparin) must be discontinued and coagulation parameters must be normalized prior to the first dose of GSK2820151. Low dose (prophylactic) low molecular weight heparin (LMWH) is permitted. In addition, INR must be monitored in accordance with local institutional practices.
Patients receiving warfarin or other vitamin K antagonists; however, if therapeutic anticoagulation is necessary, low molecular weight heparin (LMWH) is the anticoagulant of choice
Current use of warfarin (patients will be eligible if warfarin is discontinued and low-molecular weight heparin is used instead)
Contraindication or prior intolerance to thromboembolic prophylaxis with aspirin, warfarin or low-molecular weight heparin
Patients with known tumor thrombus or deep vein thrombosis are eligible if stable on low molecular weight heparin for ?4 weeks.
Currently receiving treatment with therapeutic doses of warfarin sodium. Low molecular weight heparin is allowed.
Patients on therapeutic anticoagulation, with heparin (or low-molecular weight heparin), warfarin, or a direct thrombin inhibitor as the safety of concurrent administration of curcumin has not been established
Patients receiving therapeutic doses of warfarin are not eligible for participation; Note: Patients with a need for therapeutic anticoagulation should be given low molecular weight heparin or other non-warfarin product
Requirement of anticoagulant therapy with oral vitamin K antagonists; low-dose anticoagulants for maintenance of patency of central venous access devices or prevention of deep venous thrombosis is allowed; therapeutic use of low molecular weight heparin is allowed
All study participants must be able to tolerate one of the following thromboprophylactic strategies: aspirin, low molecular weight heparin or warfarin (coumadin) or alternative anti-coagulant
Patients requiring full therapeutic anticoagulation with warfarin are ineligible because therapy on this trial may result in frequent and recurrent thrombocytopenia; full therapeutic anticoagulation with heparin, low molecular weight heparin, or direct factor Xa inhibitor is permitted
Patients requiring full therapeutic anticoagulation including warfarin, heparin, low-molecular weight heparin, or direct factor Xa inhibitor are ineligible because therapy on this trial may result in frequent and recurrent thrombocytopenia; patients requiring prophylactic dose anticoagulation may be eligible after discussion with the principal investigator
Bleeding or thrombotic disorders or use of anticoagulants such as warfarin or similar agents requiring therapeutic international normalized ratio (INR) monitoring. (Treatment with low molecular weight heparin is allowed.)
Patients on therapeutic anticoagulation with low molecular weight heparins, fondaparinux, rivaroxaban or warfarin are eligible, provided that they are on a stable dose of anticoagulants; patients who are currently receiving antiplatelet therapy of prasugrel or clopidogrel or antiaggregation agents (e.g., eptifibatide, epoprostenol, dipyridamole) or low doses of acetylsalicylic acid (up to 100 mg daily) are also eligible
Contraindication to any of the required concomitant drugs, including proton-pump inhibitor (eg, lansoprazole), enteric-coated aspirin, allopurinol or if a history of prior thrombotic disease, warfarin or low molecular weight heparin
Treatment with therapeutic doses of coumarin-type anticoagulants (maximum daily dose of 1 mg allowed for port line patency permitted); low molecular weight heparin (LMWH) will be allowed
Patients who participate in this study must be willing and able to tolerate prophylactic anticoagulation either with aspirin, low-molecular weight heparin (LMWH), or warfarin
Anticoagulants other than low molecular weight heparin.
Patients who require use of therapeutic doses of coumarin-derivative anticoagulants such as warfarin are excluded, although doses of up to 2 mg daily are permitted for prophylaxis of thrombosis; note: low molecular weight heparin is permitted provided the patient’s PT INR is =< 1.5
Patients on warfarin will be excluded from the trial if they cannot be switched to an acceptable alternative medication (i.e. low molecular weight heparin [LMWH]); prolongation of prothrombin time (PT) and International Normalized Ratio (INR) were observed in patients receiving vorinostat concomitantly with coumarin-derivative anticoagulants
Patients must not have any evidence of bleeding diathesis or be on any therapeutic anticoagulation such as low molecular weight (LMW) heparin or warfarin for deep vein thrombosis (DVT) treatment
Contraindication to aspirin; if unable to take aspirin, contraindication to warfarin or low molecular weight heparin
Current, ongoing treatment with full-dose warfarin; however patients may be on stable doses of a low molecular weight heparin are allowed (i.e. Lovenox)
Patients requiring treatment doses of heparin for any reason; the use of heparin flushes for maintenance of central venous catheters is permitted
Patients requiring warfarin/Coumadin for therapeutic anticoagulation; low molecular weight heparin is allowed
Subjects who require heparin other than low-molecular weight heparin
Anti-coagulation at baseline:\r\n* For the first 20 patients to register to trial, no anti-coagulation is allowed; patients requiring therapeutic anticoagulation with warfarin or therapeutic or prophylactic therapy with a low-molecular weight heparin at baseline are excluded\r\n* For all subsequent patients screened, patients requiring therapeutic anticoagulation with warfarin at baseline are excluded; however, therapeutic or prophylactic therapy with a low-molecular weight heparin at baseline is acceptable
Able to take low molecular weight heparin or warfarin if >= 1 additional risk factor for VTE according to IMW guidelines
Patients receiving current, ongoing treatment with full-dose warfarin or its equivalent (i.e., unfractionated and/or low molecular weight heparin) are NOT excluded
All study participants must be able to tolerate one of the following thromboprophylactic strategies: aspirin, low molecular weight heparin or warfarin (Coumadin) or alternative anti-coagulant
Therapeutic anticoagulation (e.g. warfarin, heparin, etc.) must be stopped at least 7 days prior to the first dose of MK-8628. Low-dose low molecular weight heparin (LMWH) is permitted
Currently receiving treatment with therapeutic doses of warfarin sodium. Low molecular weight heparin and oral Xa inhibitors are allowed.
Participants who require anticoagulation should receive low-molecular weight or standard heparin and not warfarin
Use of warfarin is not allowed; patient is recommended to switch to low molecular weight heparin (LMWH) before participating in this study
Patients receiving therapeutic anticoagulation; prophylactic anticoagulation of venous access devices is allowed; caution should be taken on treating patients with low dose heparin or low molecular weight heparin for deep vein thrombosis (DVT) prophylaxis during treatment with bevacizumab as there may be an increased risk of bleeding
SUNITINIB MALATE ARM: Patients who require use of therapeutic doses of Coumarin-derivative anticoagulants such as warfarin are excluded; note: low molecular weight heparin is permitted provided the patient’s prothrombin time (PT) international normalized ratio (INR) is < 1.5
Coagulopathy, including the use of Coumadin or heparin anticoagulants that cannot be discontinued for the cryoablation procedure; NOTE: heparin for line patency without detectable lab abnormalities for coagulation will be allowed
Participants on any dose of warfarin or are on full dose anticoagulation with other agents including low molecular weight heparin, antithrombin agents, antiplatelet agents and full dose aspirin within 7 days prior to study enrollment; participants on prophylactic doses of low molecular weight heparin are allowed
Are receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin, or similar agents. Participants receiving prophylactic, low-dose anticoagulation therapy are eligible provided that they are on low-molecular weight heparin or oral factor Xa inhibitors.
Confirmed acute lower extremity proximal DVT or PE for which long term treatment with low molecular weight heparin (LMWH) is indicated;
Isolated CABG or single valve repair/replacements are allowed only if either (a) AT level is less than 80% OR (b) preoperative heparin is received (unfractionated heparin [UFH] for at least 12 hours; low- molecular-weight heparin [LMWH] for more than 5 days).
Participants receiving therapeutic anti-coagulation or anti-platelet (anti-aggregant) therapies, except for therapeutic enoxaparin or low dose aspirin. Use of subcutaneous heparin prophylaxis, including low molecular weight heparin is also permitted
No active anticoagulation within 7 days of study Day 1; including acetylsalicylic acid, low molecular weight heparin, or warfarin.
Patients who require anticoagulation should receive low-molecular weight or standard heparin and not warfarin
Current use of anticoagulants at therapeutic doses within 7 days prior to study drug administration. Prophylactic use of unfractioned heparin or low molecular weight heparin is permitted
Current use of therapeutic warfarin. NOTE: Low molecular weight heparin and prophylactic low-dose warfarin are permitted
Current use of therapeutic warfarin. Low-molecular-weight heparin and prophylactic low-dose warfarin are permitted
History of thromboembolic event or other condition requiring ongoing use of anticoagulation either with warfarin or low molecular-weight heparin. Note: Occlusion of a central line is not exclusion.
Subject is currently receiving or requires anticoagulation therapy (e.g., warfarin at any dose) or any drugs (e.g., aspirin, clopidogrel, etc.) or herbal supplements that affect platelet function, with the exception of low molecular weight heparin or heparin that are used to maintain the patency of a catheter
Patients receiving treatment with vitamin K, Coumadin or other agents containing warfarin and heparin. Heparin flush to maintain patency of a central venous access device is allowed.
Patients who are on anticoagulation medication that may not be safely held for the procedure (>= 5 days for antiplatelet agents and warfarin; >= 24 hours for low-molecular weight heparin formulations) will be excluded
Patients may not be on anti-coagulants (warfarin, etc.) other than low-molecular weight heparin (LMWH)
Warfarin and its derivatives are not allowed; patient can be receiving low molecular weight heparin if clinically indicated
Patients on full dose anticoagulants or any dose of warfarin; patients on prophylactic dose of low-molecular weight or unfractionated heparin are allowed.
Concurrent use of systemic low molecular weight heparin or low dose warfarin
Patients requiring therapeutic anticoagulation (e.g., warfarin, dabigatran, heparin, or low molecular weight heparins [Lovenox, dalteparin])
For those participants receiving warfarin (Coumadin), unfractionated heparin, or low-molecular weight heparin therapy, the applicable coagulation parameter that is being monitored must be within the accepted therapeutic ranges for those indications\r\n* Note: transfusions and/or growth factor dependent participants are not excluded if the above parameters can be achieved with such support
Concurrent or prior (within 7 days of enrollment) anticoagulation therapy, except for the use of low dose coumarin-type anticoagulants or low molecular weight heparin for prophylaxis against central venous catheter thrombosis
No use of full dose, therapeutic anti-coagulation with warfarin or related anti-coagulants or unfractionated or low molecular weight heparins.
Patients receiving therapeutic anticoagulation should be switched to low molecular weight heparin (LMWH) before the first cycle of obinutuzumab
Patient is in need of anticoagulation therapy except for low-dose heparin or low-dose coumadin for maintenance of patency of central venous access or prevention of deep vein thrombosis (DVT)
Low molecular weight heparin or Novel oral anti-coagulant: stable dose within 14 days prior to registration
Thrombologic event within 3 weeks of treatment start date, unless stable on anticoagulation with low molecular weight heparin (LMWH) or Factor Xa inhibitor for at least 2 weeks
Diagnosis of symptomatic venous thromboembolism requiring therapeutic-dose anticoagulation (unfractionated or low-molecular weight heparin or oral anticoagulants) throughout the period of hematopoietic recovery
No therapeutic heparin (including low molecular weight) or Coumadin use
Therapeutic dose anticoagulation with warfarin, low molecular-weight heparin, or similar agents.
Known coagulopathy or taking heparin (including low molecular weight heparin) at full anti-coagulation doses (prophylaxis is allowed) or Coumadin at any dose; patients on aspirin or non-steroidal anti-inflammatories or other antiplatelet medicines will be allowed to participate
If taking antiplatelet or anticoagulation medication, it must be able to be discontinued prior to the procedure for an appropriate amount of time (e.g., aspirin, ibuprofen, low molecular weight heparin preparations)
Known coagulopathy or taking heparin (including low molecular weight heparin) at full anti-coagulation doses (prophylaxis is allowed) or Coumadin at any dose; patients on aspirin or non-steroidal anti-inflammatories or other antiplatelet medicines will be allowed to participate
History of allergic reactions attributed to heparin or low molecular weight heparin
Received any type of pharmacologic thromboprophylaxis (e.g. low molecular weight heparin or heparin) for > 48 hours during current hospitalization
Chronic anti-coagulation with warfarin; patients on low molecular weight heparin or fondaparinux may be enrolled
Current or planned use of anticoagulant drugs such as: warfarin, heparin, low molecular weight heparin, Plavix, or Aggrenox throughout the course of the study
History of therapeutic doses of anticoagulants including warfarin and low molecular weight heparin (e.g. for prior deep venous thrombosis and pulmonary embolisms) in the preceding year
History of therapeutic doses of anticoagulants including warfarin and low molecular weight heparin (e.g. for prior deep venous thrombosis and pulmonary embolism) in the preceding year
For patients undergoing a research only biopsy: requirement for anticoagulation with heparin, low molecular weight heparin, clopidogrel, rivaroxaban, dabigatran, apixaban, warfarin, aggrenox, fondaparux, ticagrelor, etc (aspirin and other nonsteroidal antiinflammatory drugs [NSAIDs] are ok but should be held prior to biopsy in accordance with institutional standard of care)
Current treatment with anticoagulation such as warfarin or low-molecular-weight heparin.
Anticoagulation: if currently receiving therapeutic anticoagulation with heparin, low-molecular weight heparin, or Coumadin, not eligible
No antiplatelet or anticoagulation medications allowed within 7 days prior to talimogene laherparepvec injection except low-dose heparin needed to maintain venous catheter patency.
Patients must not have any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), including but not limited to, ongoing or active infection requiring parenteral antibiotics on day 1, history of bleeding diathesis or need for concurrent anticoagulation (international normalized ratio [INR] =< 1.5 and partial thromboplastin time [PTT] within 1.1 x ULN), or psychiatric illness/social situations that would limit compliance with study requirements, interfere with subject’s safety, or obtaining informed consent; therapeutic level dosing of warfarin can be used with close monitoring of prothrombin time (PT)/INR by the site; exposure may be decreased due to enzyme induction when on treatment, thus warfarin dosing may need to be adjusted based upon PT/INR; consequently, when discontinuing dabrafenib, warfarin exposure may be increased and thus close monitoring via PT/INR and warfarin dose adjustments must be made as clinically appropriate; prophylactic low dose warfarin may be given to maintain central catheter patency
Patients requiring warfarin are not eligible
INR or prothrombin time (PT) < 1.5 x the ULN except for patients receiving anticoagulation, who must be on a stable dose of warfarin for 6 weeks prior to enrollment
Therapeutic anticoagulation with vitamin-K antagonists (e.g., warfarin) or with heparins and heparinoids; however, prophylactic anticoagulation as described below is allowed:\r\n* Low dose warfarin (1 mg orally, once daily) with prothrombin time (PT)-INR =< 1.5 x ULN is permitted; infrequent bleeding or elevations in PT-INR have been reported in some subjects taking warfarin while on regorafenib therapy; therefore, subjects taking concomitant warfarin should be monitored regularly for changes in PT, PT-INR or clinical bleeding episodes\r\n* Low dose aspirin (=< 100 mg daily)\r\n* Prophylactic doses of heparin
Any patients on warfarin therapy
Patients being treated with Warfarin.
Requires continued use of warfarin for anticoagulation and cannot stop warfarin to be safely switched to another anticoagulant
Therapeutic anticoagulation with vitamin-K antagonists (e.g., warfarin) or with heparins and heparinoids\r\n* However, prophylactic anticoagulation as described below is allowed:\r\n** Low dose warfarin (1 mg orally, once daily) with PT-INR =< 1.5 x ULN is permitted; subjects taking concomitant warfarin should be monitored regularly for changes in PT, PT-INR or clinical bleeding episodes\r\n** Low dose aspirin (=< 100 mg daily)\r\n** Prophylactic doses of heparin
Patients taking warfarin; if anticoagulation is required, the patient must be on a stable dose of a Food and Drug Administration (FDA) approved anticoagulant other than warfarin (e.g. enoxaparin, dalteparin, fondaparinux, apixaban, rivaroxaban) for at least 30 days
Therapeutic anticoagulation with vitamin-K antagonists (e.g., warfarin) or with heparins and heparinoids\r\n* However, prophylactic anticoagulation as described below is allowed:\r\n** Low dose warfarin (1 mg orally, once daily) with PT-INR =< 1.5 x ULN is permitted; infrequent bleeding or elevations in PT-INR have been reported in some subjects taking warfarin while on regorafenib therapy; therefore, subjects taking concomitant warfarin should be monitored regularly for changes in PT, PT-INR or clinical bleeding episodes\r\n** Low dose aspirin (=< 100 mg daily)\r\n** Prophylactic doses of heparin
Patients must not be receiving systemic anticoagulation with warfarin; patients must be off warfarin for 30 days prior to enrollment; patients who require anticoagulation with an agent other than warfarin will not be excluded, but must be reviewed by the principal investigator prior to enrollment
Currently using warfarin.
The patient is currently on warfarin or heparin therapy
Requires therapeutic anticoagulation with warfarin at baseline\r\n* Patients must be off warfarin or warfarin-derivative anti-coagulants for at least 7 days prior to starting study drug, however, therapeutic or prophylactic therapy with low-molecular weight heparin is allowed
Currently receiving anticoagulation therapy with warfarin;
For patients requiring anti-coagulation with vitamin K antagonists, therapeutic level dosing of warfarin can be used with close monitoring of PT/INR by the site. Exposure may be decreased due to enzyme induction when on treatment, thus warfarin dosing may need to be adjusted based upon PT/INR. Consequently, when discontinuing dabrafenib, warfarin exposure may be increased and thus close monitoring via PT/INR and warfarin dose adjustments must be made as clinically appropriate. If clinically indicated, prophylactic low dose warfarin may be given to maintain central catheter patency.
Participants receiving oral warfarin are not eligible for this study (unless warfarin is discontinued at least 7 days prior to commencement of treatment and for the duration of the study, or oral warfarin is converted to LMWH, where local clinical opinion considers this an acceptable option).
Patients receiving therapeutic doses of warfarin
Patients on warfarin
Anticoagulation is permitted but patients may not be on warfarin
Patients must not be on therapeutic anti-coagulation; prophylactic anticoagulation (i.e. low dose warfarin) of venous or arterial devices is allowed provided that the requirements for PT, INR, and PTT are met
They must not require concomitant treatment with warfarin.
International normalized ratio (INR) < 1.5, except for subjects receiving warfarin therapy; for subjects who are receiving warfarin for prophylaxis or treatment of thrombosis, INR values should be carefully monitored while patients are on study
Anticoagulation with warfarin
Therapeutic level dosing of warfarin can be used with close monitoring of PT/INR by the site; exposure may be decreased due to enzyme induction when on treatment, thus warfarin dosing may need to be adjusted based upon PT/INR; consequently, when discontinuing dabrafenib, warfarin exposure may be increased and thus close monitoring via PT/INR and warfarin dose adjustments must be made as clinically appropriate; prophylactic low dose warfarin may be given to maintain central catheter patency
Requirement for anticoagulation with warfarin
Currently receiving anticoagulation therapy with warfarin;
Requires continued use of warfarin for anticoagulation and cannot stop warfarin or be safely switched to another anticoagulant
Individuals who require therapy with warfarin
Therapeutic level dosing of warfarin can be used with close monitoring of PT/INR by the site; exposure may be decreased due to enzyme induction when on treatment, thus warfarin dosing may need to be adjusted based upon PT/INR; consequently, when discontinuing dabrafenib, warfarin exposure may be increased and thus close monitoring via PT/INR and warfarin dose adjustments must be made as clinically appropriate; prophylactic low dose warfarin may be given to maintain central catheter patency
Patients receiving chronic or acute warfarin treatment are not excluded, but should be monitored very closely or considered for switch to other therapies. P1446A-05 is both highly protein bound and a competitive inhibitor of CYP2C9 at higher concentrations and thus may potentiate the action of warfarin in patients
Patients receiving warfarin anticoagulation, who cannot be transitioned to other agents such as enoxaparin or dabigatran, and for whom anticoagulants cannot be held for up to 24 hours
Therapeutic level dosing of warfarin can be used with close monitoring of PT/INR by the site; exposure may be decreased due to enzyme induction when on treatment, thus warfarin dosing may need to be adjusted based upon PT/INR; consequently, when discontinuing dabrafenib, warfarin exposure may be increased and thus close monitoring via PT/INR and warfarin dose adjustments must be made as clinically appropriate; prophylactic low dose warfarin may be given to maintain central catheter patency
Anticoagulation with warfarin
Requirement for chronic anticoagulation with warfarin or with direct oral anticoagulants at the time of screening.
Low dose warfarin (1 mg orally, once daily) with PT-INR ? 1.5 x ULN is permitted. Infrequent bleeding or elevations in PT-INR have been reported in some subjects taking warfarin while on regorafenib therapy. Therefore, subjects taking concomitant warfarin should be monitored regularly for changes in PT, PT-INR, or clinical bleeding episodes.
Patients must not be receiving active systemic anticoagulation with heparin or warfarin; patients must be off warfarin therapy for at least 30 days prior to enrollment
Patients taking warfarin or platelet inhibitors
Requires therapeutic anticoagulation with warfarin at baseline; patients must be off warfarin or warfarin-derivative anti-coagulants for at least 7 days prior to starting study drug; however, therapeutic or prophylactic therapy with low-molecular weight heparin is allowed
Treatment with warfarin or other vitamin K antagonist; patients with using warfarin who switch to another form of anticoagulation will be eligible
Patients who require warfarin for anticoagulation (other anticoagulants are allowed)
Partial thromboplastin time (PTT) =< 60, international normalized ratio (INR) =< 1.5 x institutional ULN unless on warfarin therapy (investigator would need to determine if safe for participant to stop warfarin prior to biopsy and warfarin therapy)
Patients on warfarin for any reason
Receiving warfarin treatment
Patients must not be on phenytoin, warfarin or methadone
International normalized ratio (INR) =< 1.5 institutional ULN unless on warfarin therapy (investigator would need to determine if safe for participant to stop warfarin prior to biopsy)
Current treatment with warfarin
Therapeutic anticoagulation with vitamin-K antagonists (e.g., warfarin) or with heparins and heparinoids\r\n* However, prophylactic anticoagulation as described below is allowed:\r\n** Low dose warfarin (1 mg orally, once daily) with prothrombin time (PT)-international normalized ratio (INR) =< 1.5 x upper limit of normal (ULN) is permitted; subjects taking concomitant warfarin should be monitored regularly for changes in PT, PT-INR or clinical bleeding episodes\r\n** Prophylactic doses of heparin
Receiving warfarin
Warfarin is not permitted
Thrombolytics or treatment doses of warfarin within 28 days of initiating treatment; patients who require low dose warfarin for central venous catheter patency are allowed to enter if their dose is < 2 mg per day total AND their international normalized ratio (INR) is =< 1.5
Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low-dose warfarin and aspirin or equivalent, as long as the INR =< 2.0)
Therapeutic anticoagulation with warfarin, heparins, or heparinoids
Ongoing treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg orally [PO] daily for thromboembolic prophylaxis is allowed)
Patients receiving warfarin anticoagulation, who cannot be transferred to other agents such as enoxaparin or dabigatran, and for whom anticoagulants cannot be held for up to 24 hours will be excluded
Currently receiving treatment with therapeutic doses of warfarin sodium.
PT INR > 1.5 unless the patient is on full-dose warfarin
Patients receiving therapeutic doses of warfarin
Patients on anticoagulant therapy with unstable dose of warfarin and/or having an out-of- therapeutic range INR (> 3) within the 4 weeks prior to study entry
Requires therapeutic anticoagulation with warfarin at baseline; patients must be off warfarin or warfarin-derivative anti-coagulants for at least 7 days prior to starting study drug; however, therapeutic or prophylactic therapy with low-molecular weight heparin is allowed.
Coagulopathies - patients requiring full dose anticoagulation with warfarin are excluded, however, patients stable and on other anticoagulants can be included.
Able to take anticoagulation, warfarin or equivalent agent, as detailed in the treatment plan
Receiving chronic anticoagulation therapy (e.g. warfarin, heparin) other than aspirin
Therapeutic anticoagulation with vitamin-K antagonists (e.g., warfarin) or with heparins and heparinoids; NOTE: Prophylactic anticoagulation as described below is allowed:\r\n* Low dose warfarin (1 mg orally, once daily) with prothrombin time PT-INR =< 1.5 x ULN is permitted; subjects taking concomitant warfarin should be monitored regularly for changes in PT, PT-INR or clinical bleeding episodes\r\n* Low dose aspirin (=< 100 mg daily)\r\n* Prophylactic doses of heparin
Therapeutic anticoagulation with vitamin-K antagonists (e.g., warfarin) or with heparins and heparinoids; however, prophylactic anticoagulation as described below is allowed:\r\n* Low dose warfarin (1 mg orally, once daily) with prothrombin time (PT)-international normalized ratio (INR) =< 1.5 x ULN is permitted; infrequent bleeding or elevations in PT-INR have been reported in some subjects taking warfarin while on sorafenib or capecitabine therapy; therefore, subjects taking concomitant warfarin should be monitored regularly for changes in PT, PT-INR or clinical bleeding episodes\r\n* Low dose aspirin (=< 100 mg daily)
PT INR > 1.5 unless the patient is on full-dose warfarin
Is receiving prophylactic or therapeutic anticoagulation with warfarin or any other oral anticoagulant
Patients on warfarin or plavix
Prior warfarin-based therapies within 7 days of capecitabine treatment
Patients receiving warfarin anticoagulation, who cannot be transferred to other agents such as enoxaparin or dabigatran, and for whom anticoagulants cannot be held for up to 24 hours will be excluded
Therapeutic anticoagulation with vitamin-K antagonists (e.g., warfarin) or with heparins and heparinoids; however, prophylactic anticoagulation as described below is allowed:\r\n* Low dose warfarin (1 mg orally, once daily) with PT-INR =< 1.5 is permitted; infrequent bleeding or elevations in PT-INR have been reported in some subjects taking warfarin while on regorafenib therapy; therefore, subjects taking concomitant warfarin should be monitored regularly for changes in PT, PT-INR or clinical bleeding episodes\r\n* Low dose aspirin (=< 100 mg daily)\r\n* Prophylactic doses of heparin
International normalized ratio (INR) =< 1.5 ULN unless on warfarin therapy (investigator would need to determine if safe for participant to stop warfarin prior to surgery and warfarin therapy)
Warfarin: In-range INR (usually between 2 and 3) within 14 days prior to registration
Receiving warfarin at registration
Therapeutic anticoagulation with vitamin-K antagonists (e.g., warfarin) or with heparins and heparinoids; however, prophylactic anticoagulation as described below is allowed: 1. low dose warfarin (1 mg orally, once daily) with prothrombin time [PT]-INR =< 1.5 x ULN is permitted; subjects taking concomitant warfarin should be monitored regularly for changes in PT, PT-INR or clinical bleeding episodes; we will monitor the PT/INR weekly for patients on warfarin and liver function test every 2 weeks (total bilirubin, and AST (serum glutamic oxaloacetic transaminase [SGOT]) and ALT (serum glutamic pyruvic transaminase [SGPT]) if hepatic metastases are present or if patients are on potentially hepatoxic agents such as acetaminophen or statins; 2. low dose aspirin (=< 100 mg daily); and 3. prophylactic doses of heparin
Anticoagulation with warfarin
Are being treated with warfarin anticoagulation therapy
Receiving Warfarin
Are on an anticoagulant (warfarin, apixaban, dabigatran, and rivaroxaban) regimen
Warfarin is not permitted
Coagulation parameters\t(international normalized ratio [INR], activated partial thromboplastin time [aPTT]) =< 1.25 x institutional limits, except where a lupus anti-coagulant has been confirmed or the patient is on warfarin; patients on full dose anticoagulation must be on a stable dose for at least 14 days. If receiving warfarin, the patient must have an INR =< 3.0 without any evidence of active bleeding within 14 days prior to first dose of study treatment or a pathologic condition that carries a high risk of bleeding (tumor involvement with major blood vessels or varicies), within 28 days prior to administration of study treatment
Patients receiving full dose anticoagulation therapy (e.g., warfarin or low molecular weight [LMW] heparin) and does not meet both of the following criteria: \r\n* No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)\r\n* In-range international normalized ratio (INR) (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must meet both of the following criteria:\r\n* No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)\r\n* In-range INR (between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
Patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin; if receiving warfarin, the patient must have an INR =< 3.0 and no active bleeding (that is, no bleeding within 14 days prior to first dose of protocol therapy) or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices)
Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must meet both of the following criteria:\r\n* No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)\r\n* In-range international normalized ratio (INR) (maximum [max] =< 3) on a stable dose of oral anticoagulant for greater than 1 month or on a stable dose of low molecular weight heparin
Prothrombin time/international normalized ratio (PT/INR) < 1.4 for patients not on warfarin confirmed by testing within 14 days prior to registration; patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must meet both of the following criteria:\r\n* No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)\r\n* In-range INR (between 2.5 and 3.5) on a stable dose of warfarin-based oral anticoagulant; or on a stable dose of low molecular weight heparin; or INR between 1.5 and 2 if a Greenfield filter is in place
International normalized ratio (INR) =< 1.6 (unless receiving anticoagulation therapy); patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin; if receiving warfarin, the patient must have an INR =< 3.0 and no active bleeding (i.e., no bleeding within 14 days prior to first dose of study therapy)
Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must have no active bleeding or pathological condition that carries a high risk of bleeding, and must be on a stable dose of oral anticoagulant for 14 days or on a stable dose of low molecular weight heparin for 14 days
Participant must have adequate coagulation function as defined by international normalized ratio (INR) ? 1.5 and a partial thromboplastin time (PTT) ? 1.5 X ULN if not receiving anticoagulation therapy. Participants on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight heparin and if on warfarin must have a INR between 2 and 3 and have no active bleeding (defined as within 14 days of randomization) or pathological condition that carries a high risk of bleeding (such as, tumor involving major vessels or known varices)
Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must meet the following criteria:\r\n* No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
Partial thromboplastin time (PTT) =< 1 x institutional ULN and international normalized ratio (INR) =< 1.5 , unless participant is on full dose anticoagulation therapy obtained =<14 days prior to randomization; patients on full-dose anticoagulation are eligible if the following criteria are met:\r\n* Patient has an in-range INR (usually 2-3) on a stable dose of warfarin or other anticoagulant =< 14 days or is on a stable dose of low molecular weight heparin\r\n* Patient has no active bleeding or pathological condition that carries a high risk of bleeding (i.e., tumor involving major vessels or known varices)\r\n* Patients receiving anti-platelet agents are eligible; in addition, patients who are on daily prophylactic aspirin or anticoagulation for atrial fibrillation are eligible
Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must have no active bleeding or pathological condition that carries a high risk of bleeding and must be on a stable dose of oral anticoagulant for 14 days or on a stable dose of low molecular weight heparin for 14 days
Patients NOT on warfarin must have a prothrombin time (PT)/international normalized ratio (INR) < 1.4 within 14 days prior to registration\r\n* Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must meet BOTH of the following criteria within 14 days prior to registration:\r\n** No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)\r\n** In-range INR (between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of LMW heparin
Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must meet both of the following criteria:\r\n* No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)\r\n* In-range international normalized ratio (INR) (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin, within 14 days prior to registration
Patients on full-dose anticoagulation are eligible if the following criteria are met:\r\n* Patient has an in-range international normalized ratio (INR) (usually 2-3) on a stable dose of warfarin or is on a stable dose of low molecular weight heparin\r\n* Patient has no active bleeding or pathological condition that carries a high risk of bleeding (i.e., tumor involving major vessels or known varices) \r\n* Patients receiving anti-platelet agents are eligible; in addition, patients who are on daily prophylactic aspirin or anticoagulation for atrial fibrillation are eligible
The patient has a prothrombin time (PT) (international normalized ratio [INR]) =< 1.5 and a partial thromboplastin time (PTT) =< 3 seconds above the upper limits of normal if the patient is not on anticoagulation; if a patient is on full-dose anticoagulants, the following criteria should be met for enrollment: \r\n* The patient must have an in-range INR (usually between 2 and 3) on a stable dose of warfarin or on stable dose of low molecular weight (LMW) heparin\r\n* The patient must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. tumor involving major vessels, known varices)
International normalized ratio > 1.5 on anticoagulant therapy, active bleeding on low molecular weight heparin, or chronic condition with a high risk of bleeding.
Patients on full-dose anticoagulants (e.g., warfarin) with prothrombin time (PT) international normalized ratio (INR) > 1.5 are eligible provided that both of the following criteria are met:\r\n* The patient has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin\r\n* The patient has no active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
Patients on full-dose anticoagulants (e.g., warfarin) with prothrombin time (PT) international normalized ratio (INR) > 1.5 are eligible provided that both of the following criteria are met:\r\n* The patient has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin\r\n* The patient has no active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
Prothrombin time/international normalized ratio (PT INR) < 1.4 for patients not on warfarin confirmed by testing within 14 days prior to registration; patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW] heparin) must meet both of the following criteria:\r\n* No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)\r\n* In-range international normalized ratio (INR) (between 2.5 and 3.5) on a stable dose of warfarin-based oral anticoagulant; or on a stable dose of low molecular weight heparin; or INR between 1.5 and 2 if a Greenfield filter is in place
Therapeutic anticoagulation with drugs requiring international normalized ratio (INR) monitoring (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous devise) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid < 325 mg per day)
Therapeutic anticoagulation with drugs requiring INR monitoring (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous device) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid < 325mg per day)
Receiving therapeutic anticoagulation (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous device) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid < 325 mg once daily [QD])
Patients requiring therapeutic anticoagulation with drugs requiring INR monitoring or anti-platelet therapy, except for acetylsalicylic acid (aspirin) ? 325 mg per day, are not eligible
Therapeutic anticoagulation (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous devise) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid < 325 mg per day)
No therapeutic anticoagulation (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous device) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid < 325 mg per day); no history of clinically significant hemorrhagic or thromboembolic event in the past 6 months
Therapeutic anticoagulation (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous devise) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid < 325 mg per day)
Therapeutic anticoagulation (except for low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous device) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid < 325 mg per day)
Concomitant treatment with any of the following drugs: azathioprine, cyclophosphamide, cyclosporine, pirfenidone, full dose anticoagulation (vitamin K antagonists, dabigatran, heparin), fibrinolysis and high dose anti-platelet therapy (ex. Plavix 150 mg); prophylactic low dose heparin, heparin flush for maintenance of intravenous devices, prophylactic use of anti-platelet therapy (e.g. acetyl salicylic acid up to 325 mg/d, clopidogrel 75 mg/d, or equivalent doses) should be allowed
Therapeutic anticoagulation (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous devise) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid < 325 mg per day)
For participants who receive therapeutic anticoagulation: stable anticoagulant regimen
Not currently receiving anticoagulation therapy
Need for anticoagulation
Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors
Current use of anticoagulation therapy
INR ? 1.6 (unless receiving anticoagulation therapy).
Subjects receiving anticoagulation therapy
concomitant use of therapeutic anticoagulation
Treatment with anticoagulation or antiplatelet agents, except for aspirin dosages of ?100 mg per day, within the last 2 weeks
For participants receiving therapeutic anticoagulation: stable anticoagulant regimen and stable INR during the 28 days immediately preceding initiation of study treatment
Requirement for chronic anticoagulation
Transaminases ? 2 times above the upper limits of the institutional normal, - INR<2 (international normalized ratio) if off of anticoagulation. Patients on anticoagulation therapy with an INR>2 may be enrolled at the discretion of the investigator if they have not had any episodes of severe hemorrhage and if the site to be injected is not located in the oropharynx or another area where achieving homeostasis would be complicated by local anatomy.
On anticoagulation and unable to discontinue temporarily
Requires therapeutic doses of anticoagulants unless anticoagulation can be safely discontinued before surgery per standard practice (e.g. first deep vein thrombosis [DVT] for which anticoagulation has been at least 3 months and repeat imaging demonstrates resolution of DVT) or an inferior vena cava (IVC) filter can be used in place of anticoagulation; subjects are permitted to resume anticoagulation following surgery per discretion of treating physician and/or site standard operating procedures (SOPs)
Require therapeutic use of anticoagulation medications
Patients on therapeutic or prophylactic anticoagulation will be excluded from enrollment on the protocol; however, patients can remain on the study if they develop a thrombosis that requires therapeutic anticoagulation during the course of protocol therapy
Subject is actively on anticoagulation therapy.
Need for chronic anticoagulation therapy (chronic low dose aspirin is not an exclusion)
Subjects receiving anticoagulation therapy
Patient has a bleeding disorder or a screening platelet count <100×109/L, or requires continuous anticoagulation or bridging anticoagulation during the procedure
Patients who require ongoing anticoagulation will be excluded. Only aspirin will be permitted. Pre and post-surgical prophylactic anti-coagulation treatment is permitted
Pulmonary embolism (PE) in the 3 months before enrollment; anticoagulation is permitted as long as stable dosage for more than 3 months
Patients on prophylactic or full-dose anticoagulation are eligible, provided the treating physician believes it is safe to temporarily withhold anticoagulation
FOR ALL PHASES (Ib AND II): Participants receiving anticoagulation therapy are not allowed
Requires use of therapeutic anticoagulation prior to registration\r\n* NOTE: thromboprophylaxis with any agent is permitted
Patients judged by their urologist or preoperative evaluation center (PEC) center to be unsafe to forgo pharmacologic prophylaxis or systemic anticoagulation postoperatively (whether or not they are on systematic anticoagulation for indications other than VTE)
Requires concomitant therapeutic anticoagulation (i.e., warfarin) for reasons other than venous catheter patency
Contraindication to biopsy or prostatectomy (for neoadjuvant cohort only):\r\n* Bleeding disorders\r\n* Artificial heart valve\r\n* Prothrombin time (PT)/partial thromboplastin time (PTT) >= 1.5 x ULN in patients not taking anticoagulation; patients on anticoagulation (e.g. enoxaparin, oral anticoagulants) are eligible regardless of PT/PTT; prior to biopsy, anticoagulation will be held per standard practice
anticoagulation with inability to stop anticoagulants prior to surgery
Is on anticoagulation that cannot be discontinued in the perioperative stage
Requirement for anticoagulation treatment that increases INR or aPTT above the normal range (low dose DVT or line prophylaxis is allowed).
Patients on anticoagulation therapy which cannot be held for metastatic biopsies
Abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants (that cannot be safely held for biopsy) that would preclude tumor and skin biopsies\r\n* For fulvestrant: ongoing anticoagulation that would preclude an IM injection\r\n* For tamoxifen: documented hypercoagulable state not receiving anticoagulation
Unable or unwilling to take any prophylaxis; patients with history of or new/active deep vein thrombosis/embolism/thrombophilia are allowed to participate if they are on appropriate therapeutic anticoagulation during the treatment on the trial; these patients would not need the aspirin with the lenalidomide unless clinically indicated; therefore, patients must be able and willing to receive anticoagulation (prophylaxis versus therapeutic as clinically indicated)
Patients who require ongoing anticoagulation will be excluded; only aspirin will be permitted; pre and post-surgical prophylactic anti-coagulation treatment is permitted
Patients on therapeutic anticoagulation; Note: prophylactic anticoagulation (i.e. intraluminal heparin) for venous or arterial access devices is allowed
Need for ongoing therapeutic anticoagulation
Subject is receiving anticoagulation; washout period of 7 days
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Chronic anticoagulation, not including aspirin, but including heparins, warfarin, oral anticoagulation or other platelet function inhibitors
Patients receiving therapeutic non-Coumadin anticoagulation are eligible, provided they are on a stable dose (per investigator judgment) of anticoagulant
Patients on therapeutic anticoagulation
Patients requiring therapeutic anticoagulation and irreversible platelet inhibitors (e.g. clopidogrel, prasugrel, or ticagrelor). Low dose aspirin for cardiac prophylaxis is allowed.
Current use of anticoagulation; NOTE: use of low-dose anticoagulation medications (such as heparin) that are used to maintain the patency of a central intravenous catheter is allowed
Patients with TE event occurring > 6 months prior to enrollment and receiving active anticoagulation
Patients requiring therapeutic anticoagulation
Patients on therapeutic anticoagulation Note: prophylactic anticoagulation (i.e. intraluminal heparin) for venous or arterial access devices is allowed
Patients must not be on any anticoagulation
Use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily reversed or stopped for a window of at least 7 days peri-procedure
Therapeutic anticoagulation is not contraindicated, but for those patients on therapeutic anticoagulation, alteration in coagulation parameters is expected following initiation of dasatinib; for patients on therapeutic anticoagulation, coagulation parameters should be assessed weekly for the first cycle following initiation of dasatinib, weekly for the first cycle following a dose reduction, and weekly for a minimum of two weeks after stopping dasatinib
Anticoagulation with Lovenox (enoxaparin) is permitted, however, patients on anticoagulation with warfarin are not permitted on this study
Require therapeutic anticoagulation treatment, especially with Coumadin
Concomitant anticoagulation, at therapeutic doses, with anticoagulants.
Patients on oral anticoagulation therapy
In the absence of therapeutic intent to anticoagulate the patient: INR > 1.5 or PT > 1.5 xULN or aPTT > 1.5 xULN Therapeutic anticoagulation.
Abnormal coagulation and current anticoagulant therapy. Patients whose anticoagulation therapy can be temporarily reversed within 7 days prior to treatment are eligible. Platelet inhibitors (ie: ASA) and heparin are not exclusion criteria.
Prothrombin Time or INR ?1.5x upper limit of normal (ULN) unless receiving therapeutic anticoagulation.
Concomitant medications: patients receiving anticoagulation should be on stable dose 2 weeks prior to registration
For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
Chronic anticoagulation, not including aspirin, but including heparins, warfarin, oral anticoagulation or other platelet function inhibitors, that can not, in the documented opinion of the investigator, safely be interrupted from at least 2 days prior to the initiation of the study regimen until after surgical resection of the tumor.
Concurrent treatment with anticoagulation medication, unless approved by Sponsor
Patients using oral or parenteral anticoagulation are not excluded provided they are on a stable dose of anticoagulant
Subject undergoing cardiothoracic surgery with anticoagulation must have anticoagulation reversed prior to target bleeding site (TBS) identification and treatment;
Patients must not be receiving therapeutic anticoagulation
Patients requiring anticoagulation or with uncontrolled bleeding are excluded
Subjects requiring therapeutic doses of anticoagulation or anti-platelet therapies (aspirin above 81 mg daily, Plavix or similar agents) AND platelet counts are below 50,000 on two different laboratory evaluations, separated by minimum of two weeks
Patients on active therapeutic anticoagulation
Anticoagulation is permitted but patients may only be on lovenox for this purpose.
Ongoing therapy with oral or parenteral anticoagulants; low-dose anticoagulation to maintain patency of lines is allowed
Stable dose Coumadin anticoagulation is allowed, providing that anticoagulation can be safely held to an international normalized ratio (INR) within normal range for the purpose of tumor biopsy; low molecular weight heparin (LMWH) is the preferred method of anticoagulation
Active bleeding tendency; NOTE: patients on therapeutic anticoagulation should be monitored carefully to maintain therapeutic level of anticoagulation to avoid increased risk of bleeding due to concurrent drug induced thrombocytopenia; it is suggested that patients who require anticoagulation therapy while on therapy use low molecular weight heparin (LMWH)
Concomitant anticoagulation with oral anticoagulants.
Prothrombin time or INR =< 1.5 x ULN unless receiving therapeutic anticoagulation
Patients on chronic anticoagulation such as Aspirin, Plavix, or Coumadin who cannot have anticoagulation held for procedures are not eligible
use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily reversed or stopped;
If on anticoagulation, participant must be on stable therapeutic dose prior to enrollment
Coagulopathy or anticoagulation therapy that cannot be safely corrected or interrupted for tumor biopsy
Prothrombin time (PT) =< 1.5 x upper limit of normal unless patient is receiving anticoagulants; if patient is on anticoagulation therapy, levels should be within therapeutic range, or
Current use of therapeutic anticoagulation therapy
Had full-dose anticoagulation with heparin, enoxaparin, dalteparin, other LMWH, a/or other anticoagulants w/in 90 days before first dose of M402
Evidence of bleeding diathesis or coagulopathy; patients that are on anticoagulation therapy for deep vein thrombosis (DVT) will be allowed to enroll and continue on the treatment dose of enoxaparin or other anticoagulation such a warfarin
Patients must not be on any anticoagulation
Able to take required prophylactic anticoagulation.
History of bleeding diathesis, known factor X deficiency (level < 20%), or requirement for therapeutic anticoagulation with warfarin
Active therapeutic anticoagulation
Therapeutic anticoagulation
Patients on fibrinolysis, full-dose therapeutic anticoagulation, or high dose antiplatelet therapy
Continuous anticoagulation therapy; patients who were on anticoagulant therapy must complete a washout period of at least 10 days and have confirmed normal coagulation parameters before study inclusion
Patient receiving anticoagulation
Use of therapeutic anticoagulation within 5 days of surgery (not including venous thromboembolism prophylaxis)
Active or recent (within prior 3 months) thrombus, irrespective of anticoagulation status
Documented venous thromboembolism while on therapeutic anticoagulation (“anticoagulation failure”)
Currently receiving anticoagulation treatment
Current oral steroid use or receiving daily therapeutic anticoagulation (e.g. Coumadin, Lovenox)
Documented venous thromboembolism while on therapeutic anticoagulation (“anticoagulation failure”)
Require chronic anticoagulation or anti-platelet therapy
Women on anticoagulation
Protein C deficiency (increased risk of skin necrosis do those on injectable anticoagulation)
For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
Require chronic anticoagulation or anti-platelet therapy
Patients with confirmed symptomatic PE and/or DVT who have been treated for 6 to 12 months and did not interrupt anticoagulation for longer than 1 week
a condition requiring prolonged anticoagulation or anti-platelets
Subjects on anticoagulation (other than aspirin) whom cannot have their anticoagulation held for the procedure due to other clinical reasons (i.e. recent cardiac stent placement)
Subjects on anticoagulation (other than aspirin) whom cannot have their anticoagulation held for the procedure due to other clinical reasons (i.e. recent cardiac stent placement)
Patients who require anticoagulation for whom biopsy would be contraindicated.
Active therapeutic anticoagulation
Patient receiving therapeutic anticoagulation
Subjects requiring anticoagulation not eligible
Require therapeutic use of anticoagulation medications