[c09aa8]: / clusters / 9knumclustersv2 / clust_1365.txt

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Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Common Terminology Criteria for Adverse Events (CTCAE) grade or baseline, with the exception of alopecia)
Patients must have completed prior chemotherapy, immunotherapy, or radiation therapy at least days prior to step randomization and all toxicity must be resolved to Common Terminology Criteria for Adverse Events (CTCAE) version (v). grade (with the exception of CTCAE v. grade neuropathy) prior to step randomization
Persistent toxicities (>= Common Terminology Criteria for Adverse Events [CTCAE] grade ) caused by previous cancer therapy, excluding alopecia and CTCAE grade peripheral neuropathy
Recovered from adverse events to grade or less toxicity according to Common Terminology Criteria for Adverse Events version . (CTCAE .) due to agents administered previously\r\n* NOTE: Chemotherapy-induced alopecia and grade neuropathy are acceptable
Persistent toxicities (>= Common Terminology Criteria for Adverse Events [CTCAE] grade ) caused by previous cancer therapy, excluding alopecia
Recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade or less toxicity from other agents with exception of alopecia and fatigue
Patients who have not recovered to < Common Terminology Criteria for Adverse Events (CTCAE) grade toxicities related to prior therapy are ineligible
Has had chemotherapy, radiation or biological cancer therapy within weeks prior to the first dose of study drug, or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade or from the AEs due to cancer therapeutics administered more than weeks earlier (this includes participants with previous immunomodulatory therapy with residual immune-related [ir]AEs).
Prior locoregional liver directed therapy is allowed as long as treatment was at least weeks prior to study registration, and clear progression is demonstrated by RECIST v. criteria; subject must have recovered from the acute toxic effects (=< grade Common Terminology Criteria for Adverse Events [CTCAE] v) of previous anti-cancer treatment prior to study enrollment; the only exception is that grade neuropathy is permitted
Failure to recover (to Common Terminology Criteria for Adverse Events [CTCAE Version .] Grade or Grade ) from acute non-hematologic toxicity (except alopecia or Grade or lower neuropathy), due to previous therapy, prior to Screening.
Chemotherapy, radiotherapy, and/or biological cancer therapy within weeks prior to the first trial dose or has not recovered to CTCAE v. grade or better from adverse events (except alopecia).
Participants who have not recovered to =< Common Terminology Criteria for Adverse Events (CTCAE) grade or baseline from toxicity as a result of previous cancer treatment prior to entering the study (with the exception of alopecia and peripheral neuropathy which can be =< grade )
Participants who have had chemotherapy, biologic therapy, or investigational therapy within days (including bevizumab) or radiotherapy within days prior to entering the study or those who have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) =< grade or baseline from adverse events due to agents administered
Recovered from adverse events (to grade or less toxicity according to Common Terminology Criteria for Adverse Events [CTCAE] .) due to agents administered previously; NOTE: chemotherapy-induced alopecia and grade neuropathy are acceptable
All previous therapies for cancer, including radiotherapy, major surgery and investigational therapies discontinued for ? days (? days for mitomycin C or nitrosoureas) before study entry, and all acute effects of any prior therapy resolved to baseline severity or Grade ? Common Terminology Criteria for Adverse Events (CTCAE v.), except alopecia or parameters defined in this eligibility list.
Patients must be recovered from any toxicity related to prior anti-neoplastic therapy (to grade < ); patients with Common Terminology Criteria for Adverse Events (CTCAE) grade or less sensory neuropathy or any grade alopecia are eligible
Lack of recovery of prior adverse events due to prior cancer therapy to grade =< (NCI Common Terminology Criteria for Adverse Events [CTCAE]; except alopecia); electrolyte abnormalities that are corrected with supplementation will be eligible; patients with platinum-related grade or greater hypomagnesemia (on replacement) will be eligible; stable persistent grade peripheral neuropathy may be allowed as determined on a case-by-case basis at the discretion of the principal investigator (PI)
Patients with persistent toxicities (>= Common Terminology Criteria for Adverse Events [CTCAE] grade ) with the exception of alopecia, caused by previous cancer therapy
Persistent prior therapy-related toxicities greater than grade according to Common Toxicity Criteria for Adverse Events (CTCAE) v., except for peripheral neuropathy, alopecia, or vitiligo prior to enrollment.
Subjects with >= Common Terminology Criteria for Adverse Events (CTCAE) grade toxicity (except alopecia) due to prior cancer therapy.
Persistent toxicities (>= common terminology criteria for adverse events grade ) with the exception of alopecia, caused by previous cancer therapy.
Must have completed prior chemotherapy, immunotherapy, or radiation therapy at least days prior to start of treatment and all toxicity must be resolved to Common Terminology Criteria for Adverse Events (CTCAE) v. grade (with the exception of CTCAE v. grade neuropathy) prior to start of treatment
The patient has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade or better from adverse event at time of enrollment due to cancer therapy administered more than days prior to enrollment
Persistent toxicities (> Common Terminology Criteria for Adverse Event [CTCAE] grade ) caused by previous cancer therapy, excluding alopecia
Patients who have not recovered from adverse events attributed to prior anti-cancer therapy (i.e. have residual toxicities > grade , except for alopecia, neuropathy, lymphocytopenia and other non-clinically significant adverse events)
Persistent toxicities (>= Common Terminology Criteria for Adverse Events [CTCAE] grade ), with the exception of alopecia, caused by previous cancer therapy
Residual acute toxic effects of prior anti-cancer therapy that have not resolved to Common Terminology Criteria for Adverse Events version (CTCAE v.) grade =< (except alopecia or other grade II or above toxicities not considered a safety risk for the patient at investigator's discretion)
Fully recovered from acute toxicities (except alopecia) of all prior therapies to Common Terminology Criteria for Adverse Events (CTCAE) =< grade
Has not recovered from adverse events due to prior therapies, i.e. monoclonal antibody, chemotherapy, targeted small molecule therapy, radiation therapy, or surgery.\r\n* Note: Subjects with grade neuropathy, alopecia and general disorders and administration site conditions (per Common Terminology Criteria for Adverse Events [CTCAE] version .) are an exception to this criterion and may qualify for the study.
All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version .) less than or equal to grade (except alopecia) at the time of screening however clinically relevant adverse events (AEs) that will impact on the adverse drug event (ADE) of the study drugs or safety of the subject must have resolved to grade or better
Patients who received prior medical therapy for a NF related tumor must have recovered from the acute toxic effects of all prior therapy to =< grade Common Terminology Criteria for Adverse Events (CTCAE) version (v) before entering this study
PHASE I AND II SCLC AND UROTHELIAL CARCINOMA EXPANSION COHORT: Persistent toxicities (>= Common Terminology Criteria for Adverse Events [CTCAE] grade ) with the exception of alopecia and neuropathy, caused by previous cancer therapy
Patients must have recovered from toxicity related to prior therapy to at least grade (defined by Common Terminology Criteria for Adverse Events version . [CTCAE .]) or baseline level; chronic stable grade peripheral neuropathy secondary to neurotoxicity from prior therapies may be considered on a case by case basis by the principal investigator
Must have recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade or better from the acute effects of any prior surgery, chemotherapy or radiation therapy; chronic residual toxicity (i.e. peripheral neuropathy) is permitted
Persistence of any clinically relevant (Common Terminology Criteria for Adverse Events [CTCAE] grade or above) toxicities from previous AML therapy
Must have recovered from adverse effects of any prior surgery, radiotherapy or other antineoplastic therapy; Common Terminology Criteria for Adverse Events (CTCAE) adverse events less than or equal to grade are acceptable; CTCAE adverse events grade or greater may be acceptable as determined by the principal investigator
All previous therapies for cancer, including radiotherapy, major surgery and investigational therapies must be discontinued for >= days (>= days for mitomycin C or nitrosoureas) before cycle day (CD), and all acute effects of any prior therapy must have resolved to baseline severity or grade =< Common Terminology Criteria for Adverse Events (CTCAE version [v] .), except alopecia or parameters defined in this eligibility list
PHASE I: Persistent toxicities (> Common Terminology Criteria for Adverse Event [CTCAE] grade ) caused by prior cancer therapy, excluding alopecia
PHASE II: Persistent toxicities (> Common Terminology Criteria for Adverse Event [CTCAE] grade ) caused by prior cancer therapy, excluding alopecia
Patients eligible or ineligible for cisplatin-based chemotherapy. Cisplatin ineligibility is defined as meeting of the following criteria: Creatinine clearance (calculated or measured) < mL/min calculated by Cockcroft-Gault equation (using actual body weight) or by measured -hour urine collection for determination Common Terminology Criteria for Adverse Events (CTCAE) Grade ? audiometric hearing loss CTCAE Grade ? peripheral neuropathy New York Heart Association ?Class III heart failure.
Have received anti-cancer therapies listed below within the specified timeframe, or who have ongoing toxicity from prior therapy > Grade according to the Common Terminology for Adverse Events (CTCAE). Exceptions to this are: > Grade toxicities which in the opinion of the Investigator should not exclude the subject (e.g. alopecia, Grade neuropathy, hypo- or hyperthyroidism or other endocrinopathies that are well-controlled with hormone replacement) and are approved by the Medical Monitor.
Other organ toxicity due to prior anticancer therapy (investigational agent, chemotherapy, or radiation therapy) except alopecia, and ototoxicity due to cisplatin not already covered in the inclusion/exclusion criteria, which has not recovered to Grade less than per Common Terminology Criteria for Adverse Events (CTCAE) v..
Has not recovered from adverse events due to prior therapies, i.e. monoclonal antibody, chemotherapy, targeted small molecule therapy, radiation therapy, or surgery; (Note: subjects with grade neuropathy, alopecia and general disorders and administration site conditions [per Common Terminology Criteria for Adverse Events (CTCAE) version .] are an exception to this criterion and may qualify for the study)
Experiencing any clinically significant adverse events above grade (according to Common Terminology Criteria for Adverse Events [CTCAE] .) due to agents administered more than days earlier; however, patients with grade alopecia will be considered eligible
Patients who have not recovered (=< Common Terminology Criteria for Adverse Events [CTCAE] grade ) from adverse events (with the exception of alopecia) due to agents administered more than weeks earlier
Chemotherapy, radiation, or biological cancer therapy within weeks prior to the first dose of study drug, or who has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade or better from the adverse events due to cancer therapeutics administered more than weeks earlier
Resolution of all chemotherapy or radiation-related toxicities =< Common Terminology Criteria for Adverse Events (CTCAE) grade severity, except for alopecia and hematologic toxicity; patients taking temozolomide can start study treatment days from the last temozolomide dose; for all other chemotherapy drugs, study treatment can start as long as adverse events related to their treatment is =< to grade
Patients must have recovered from all acute toxicities (defined as Common Terminology Criteria for Adverse Events [CTCAE] . =< grade ) associated with any prior therapy
History of infection meeting any of the following criteria:\r\n* Any infection that would be scored as grade by Common Terminology Criteria for Adverse Events (CTCAE) that occurred within six weeks of study screening\r\n* Any infection that would be scored as grade by CTCAE that occurred within two weeks of study screening\r\n* History of fungal and mycobacterial infections, unless at least six weeks has passed since the completion of induction antimicrobial therapy; patients may be receiving consolidation therapy for infections of these types
Patients who have been treated with most recent radiotherapy, hormonal therapy, immunotherapy, chemotherapy or investigational drugs within ? days or half-lives (whichever is shorter) from enrolment (screening), and/or who have any unresolved NCI Common Terminology Criteria of Adverse Events (CTCAE) v. > Grade treatment-related side effect (with the exception of alopecia).
Recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade < or equal to from toxicities related to prior therapy within weeks prior to start of any therapy
Persistent toxicities (> Common Terminology Criteria for Adverse Event [CTCAE] grade ) caused by previous cancer therapy, excluding alopecia
Patient who has had chemotherapy, radiation therapy, or biological cancer therapy within four weeks prior to the first dose of study drug, or who has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade or better from the adverse events (AEs) due to cancer therapeutics administered more than four weeks earlier
Fully recovered from acute toxicities (except alopecia) of all prior therapies to Common Terminology Criteria for Adverse Events (CTCAE) =< grade
Persistent toxicities (> Common Terminology Criteria for Adverse Events [CTCAE] grade ) caused by previous cancer therapy, excluding alopecia.
Patient has not recovered to CTCAE Common Terminology Criteria for Adverse Events (CTCAE) (version .) grade or better (except alopecia) from related side effects of any prior antineoplastic therapy.
Any acute toxicities due to prior chemotherapy and / or radiotherapy that have not resolved to a Common Terminology Criteria for Adverse Events version . grade <= with the exception of chemotherapy induced alopecia and grade peripheral neuropathy.
Part patients who have not recovered to < Common Terminology Criteria for Adverse Events (CTCAE) grade toxicities related to prior therapy are ineligible
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Common Terminology Criteria for Adverse Events [CTCAE] grade or baseline, with the exception of alopecia)
Patients who have not recovered to < Common Terminology Criteria for Adverse Events (CTCAE) grade toxicities related to prior therapy are ineligible
Previous chemotherapy (adjuvant and metastatic regimens) and hormonal therapy allowed, but chemotherapy must have been discontinued at least days prior to starting study treatment and hormonal therapy at least days prior to starting study treatment; patients must have recovered from acute Common Terminology Criteria for Adverse Events (CTCAE) version (v) . grade >= side effects of previous treatments; participants with alopecia G (CTCAE v.) will be allowed in the study
Toxicities (> Common Terminology Criteria for Adverse Events [CTCAE] grade ) caused by previous cancer therapy
Prior systemic or antiangiogenic therapy for HCC (including thalidomide, sorafenib, sunitinib, or bevacizumab); prior systemic therapy for other diagnoses is permitted if greater than months have elapsed since last dose, any prior toxicity has recovered to =< grade by Common Terminology Criteria for Adverse Events (CTCAE) version (v) ., and treatment was not discontinued for toxicity
PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have received any chemotherapy, biologic agent, or any investigational agent within days prior to registration. Patients must have recovered from any adverse events to Common Terminology Criteria for Adverse Events (CTCAE) grade - prior to registration
Toxicities from previous cancer therapies must have recovered to grade (defined by Common Terminology Criteria for Adverse Events [CTCAE] .) Chronic stable grade peripheral neuropathy secondary to neurotoxicity from prior therapies may be considered on a case by case basis
All previous chemotherapy or radiation therapy-related toxicities, except dry mouth, dysphagia, esophagitis, mucositis, alopecia, and irreversible late sequelae of radiation therapy, must have resolved to Grade or per Common Terminology Criteria for Adverse Events (CTCAE v .), and all wounds from prior surgery must have adequately recovered.
Adverse event due to cancer therapy administered more than days prior to enrollment that has not recovered to CTCAE grade or better.
Failure to recover (to Common Terminology Criteria for Adverse Events [CTCAE] Grade or Grade ) from acute non hematologic toxicity (except all grades alopecia or Grade or lower neuropathy ), due to previous therapy, prior to Screening.
Has recovered from the toxic effects of prior therapy to Common Terminology Criteria for Adverse Events (CTCAE) grade or to their clinical baseline
Not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade from toxicity due to all prior therapies except alopecia and neuropathy; alopecia and neuropathy must have resolved to =< grade ; congestive heart failure (CHF) must have been =< grade in severity at the time of occurrence and must have resolved completely prior to registration
Subject has not recovered from adverse reactions to prior cancer treatment or procedures (surgery, chemotherapy, immunotherapy, radiation therapy) to Common Terminology Criteria for Adverse Events (CTCAE) Grade or better.
Partcipant has not recovered from the acute toxic effects (Common Terminology Criteria for Adverse Events [CTCAE] grade ? ) of prior anticancer therapy, radiation, or major surgery/significant trauma (except alopecia or other toxicities not considered a safety risk for the particiapants at the Investigator's discretion).
Prior therapy (chemotherapy, radiation therapy, and surgery) is allowed if completed at least weeks prior to registration and if all treatment-related toxicities are resolved to =< Common Terminology Criteria for Adverse Events (CTCAE) grade , with the exception of alopecia and hematologic values otherwise meeting the bone marrow function criteria
Participants must have recovered from the acute toxic effects of prior therapy to a grade (Common Terminology Criteria for Adverse Events [CTCAE] v..) level prior to enrollment (does not apply to alopecia)
Persistent toxicities (> Common Terminology Criteria for Adverse Event [CTCAE] grade ) caused by previous cancer therapy, excluding alopecia.
Has had chemotherapy, definitive radiation, or biological cancer therapy within weeks (prior to the first dose of study therapy, or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Gr or better from any AEs that were due to cancer therapeutics administered more than weeks earlier
Last chemotherapy or treatment with another systemic anti-cancer agent must have stopped >= weeks prior to enrollment (or >= half-lives for oral tyrosine-kinase inhibitors or weeks for palliative radiotherapy); participants must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] =< or baseline) from acute toxicities of any previous therapy (with the exception of alopecia)
Patients that have not recovered from adverse events related to prior chemotherapy, radiation therapy or multikinase inhibitors to Common Terminology Criteria for Adverse Events (CTCAE) . grade or less except for alopecia
Subjects must be recovered from any toxicity related to prior anti?neoplastic therapy (to grade =< ); patients with Common Terminology Criteria for Adverse Events (CTCAE) grade or less sensory neuropathy or any grade alopecia are eligible
Persistent toxicities (> Common Terminology Criteria for Adverse Event [CTCAE] grade ) caused by previous cancer therapy, excluding alopecia;
Any persistent, unresolved Common Terminology Criteria for Adverse Events (CTCAE) Grade ? drug-related toxicity (except alopecia, erectile impotence, tinnitus, hot flashes, and loss of libido) associated with previous treatment. Inclusion of patients with persistent neuropathy or hearing loss Grade ? due to previous treatment requires discussion with the sponsor.
Has not recovered (i.e., equivalent to a Common Terminology Criteria for Adverse Events [CTCAE] ?Grade ) from the clinically significant toxic effects of prior anticancer therapy. Exception: subjects who have received treatment with a proteasome inhibitor such as bortezomib may have CTCAE Grade neuropathy.
Lack of recovery of prior cancer therapy-related adverse events to grade =< (NCI Common Terminology Criteria for Adverse Events [CTCAE] v.; except alopecia); stable persistent grade peripheral neuropathy may be allowed as determined on a case-by-case basis at the discretion of the principal investigator (PI); patients with platinum-related grade or greater hypomagnesemia (on replacement) will be eligible
Has had chemotherapy, radiation, or biological cancer therapy within weeks prior to the first dose of study therapy, or who has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade or better from the adverse events due to cancer therapeutics administered more than weeks earlier
Patients who have not recovered (Common Terminology Criteria for Adverse Events [CTCAE] =< grade ) from adverse events due to prior treatments, except for alopecia, or base stable grade tinnitus (not interfering with activities of daily living [ADL]s) or stable grade sensory neuropathy without pain or motor component, and not interfering with ADLs
Failure to recover to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade from clinically significant toxicities due to prior cancer therapies or to any investigational agents
Subject who has an ongoing toxicity ? Grade (Common Terminology Criteria for Adverse Event [CTCAE] v.) attributable to prior medication to treat solid tumor (except alopecia) at the time of screening.
Patients may not have any baseline comorbidities or laboratory abnormalities which would be of grade or worse if graded as toxicities by Common Terminology Criteria for Adverse Events (CTCAE) (excepting alopecia); an exception is also made for neurologic comorbidities (e.g. ataxia, aphasia) arising as a consequence of the brain tumor; symptoms severe enough to warrant medical treatment as is offered on this study are by definition grade
Subject has persistent nonhematological toxicities of >= Grade (Common Terminology Criteria for Adverse Events v), with symptoms and objective findings, from prior AML treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, or surgery).
Must have recovered from any acute toxicity related to prior therapy, including surgery; toxicity should be =< grade Common Terminology Criteria for Adverse Events (CTCAE) version or has returned to baseline; alopecia > grade is permitted
Subjects who have not recovered from acute toxicities as a result of prior anti-cancer therapy to less than or equal to Grade , according to Common Terminology Criteria for Adverse Events (CTCAE), except for peripheral neuropathy (see Exclusion ) and alopecia.
Last dose of chemotherapy or experimental therapy more than weeks ( weeks in the case of nitrosourea) prior to enrollment date; unless the last therapy consisted of an oral agent whose average half life is known to be less than hours in which case only weeks need to have elapsed; regardless of the therapy, any toxicity greater than Common Terminology Criteria for Adverse Events (CTCAE) grade from previous anti-cancer therapy must have been resolved
Subject has an ongoing toxicity ? Grade (Common Terminology Criteria for Adverse Event [CTCAE] v.) attributable to prior medication to treat solid tumor (except alopecia) at the time of screening.
Presence of >= Common Terminology Criteria for Adverse Events (CTCAE) grade toxicity (except alopecia) due to prior therapy
Recovered from adverse events (to grade or less toxicity according to Common Terminology Criteria for Adverse Events [CTCAE] .) due to agents administered previously; NOTE: chemotherapy-induced alopecia and grade neuropathy are acceptable
Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade <= severity (Common Terminology Criteria for Adverse Events [CTCAE] v., or later versions)
Has not recovered to Common Toxicity Criteria for Adverse Events Grade or better from the adverse events due to cancer therapeutics administered more than weeks prior to the first dose of study treatment