[c09aa8]: / clusters / 9knumclustersv2 / clust_2062.txt

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Persistent clinically significant toxicities (>= CTCAE version [v.] . grade ) caused by previous cancer therapy, with the exception of alopecia
Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or certain Grade toxicities, which in the opinion of the investigator should not exclude the participant a. Any known history of Grade thrombocytopenia with any prior chemotherapy regimen
Unresolved toxicities from prior anticancer therapy that have not resolved to CTCAE, version ., grade =< or baseline, with the exception of alopecia and laboratory values listed
Has not recovered from the adverse effect of previous anticancer treatments to pre-treatment baseline or Grade except for alopecia, anemia (hemoglobin must meet the study inclusion criteria) and peripheral neuropathy (which must have recovered to ? Grade ).
Ongoing adverse event from previously administered systemic anti-cancer therapy unless has recovered to =< grade or at baseline prior to CD\r\n* Subjects with any grade alopecia or =< grade neuropathy are an exception to this criterion and may qualify for the study
Subject has toxicity from previous anticancer therapy that has not recovered to ? Grade or to their baseline level of organ function prior to enrollment (except for non-clinically significant toxicities, e.g., alopecia, vitiligo).
All ACT related toxicities resolved to grade with the exception of alopecia, vitiligo and endocrine abnormalities requiring replacement therapy which may be grade
All clinically significant toxicities from prior systemic therapy must be =< grade (with the exception of alopecia, endocrinopathies associated with prior immunological therapies as long as they are stable with replacement therapy, and peripheral neuropathy, which may be =< grade )
Persistent toxicities (>= CTCAE grade ) with the exception of alopecia, caused by previous cancer therapy
Has not recovered from reversible toxicity of prior anticancer therapy (except toxicities which are not clinically significant such as alopecia, skin discoloration, or Grade neuropathy)
Grade or greater toxicities due to previous therapies, subject to laboratory abnormalities listed below. Stable, tolerable Grade adverse events may be allowed at discretion of Investigator
Not recovered to less than or equal to Grade toxicities (except Grade alopecia or neuropathy) associated with previous cancer therapies
Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE v, grade =< or baseline. Subjects with chronic grade toxicities may be eligible per the discretion of the Investigator and Sponsor (eg, grade chemotherapy-induced neuropathy).
Participants who have not recovered to =< 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 )
Acute toxicities from any prior anti-tumor therapy, surgery, or radiotherapy that has not resolved to Grade </=, except alopecia
Patients must have recovered from adverse events (greater than grade ) due to prior anticancer therapy, except for stable chronic toxicities such as alopecia
All toxicities (except alopecia) from prior cancer treatments must have resolved to ? Grade or returned to baseline levels prior to enrollment
Vitiligo or alopecia.
The patient has persistent clinically significant ?Grade toxicities from previous anticancer therapy (excluding Grade chemotherapy-related neuropathy which is permitted, and excluding Grade - laboratory abnormalities if they are not associated with symptoms, are not considered clinically significant by the Investigator, and can be managed with available medical therapies).
Patients who have received prior chemotherapy, other ALK inhibitors, biologic therapy, or other investigational agents, must have recovered from all toxicities related to prior anticancer therapies to grade ? (CTCAE v .). Patients with grade ? peripheral neuropathy or any grade of alopecia, fatigue, nail changes or skin changes are allowed to enter the study
Patient has recovered (to Grade ?) from all clinically significant toxicities related to prior antineoplastic therapies (with the exception of alopecia)
Ongoing prior toxicities related to previous treatments must be recovered to < grade at the time of registration (with the exception of alopecia, grade peripheral neuropathy or lymphopenia)
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual drug related toxicities > grade ) except for alopecia and grade fatigue
Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade or less except for alopecia or peripheral neuropathy
Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade or less except for alopecia or peripheral neuropathy
All non-hematological toxicity of previous cancer therapy should have resolved to =< grade (except alopecia or other toxicities not involving major organs)
Resolution of all toxicities from prior therapy to ?Grade (or baseline) within week prior to the first dose of study drug (excluding alopecia and ?Grade clinically asymptomatic lipase, amylase, and creatine phosphokinase laboratory abnormalities).
Toxicities from previous cancer therapies resolved to =< grade unless specified otherwise in the inclusion or exclusion criteria (Exceptions: Chronic residual toxicities that in the opinion of the investigator are not clinically relevant given the known safety/toxicity profiles of pemetrexed and sorafenib, such as alopecia, changes in pigmentation, stable endocrinopathies; neuropathy related to previous chemotherapy must be resolved to =< grade )
Persistent toxicities (> CTCAE grade ) with the exception of alopecia, caused by previous cancer therapy
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nToxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade as per CTCAE v . except hemoglobin; patients with long-standing stable grade neuropathy may be considered after discussion with the PI
Non-hematologic toxicities from previous cancer therapies resolved to =< grade except chronic residual toxicities that in the opinion of the investigator are not clinically relevant given the known safety/toxicity profiles of regorafenib and sildenafil (eg, alopecia, changes in pigmentation, stable endocrinopathies)
Recovery from >= grade toxicities of prior therapy regimen to grade or baseline, with the exception of anemia and lymphopenia and chronic residual toxicities that in the opinion of the investigator are not clinically relevant given the known safety/toxicity profiles of gemcitabine, sorafenib, and vorinostat (eg, alopecia, changes in pigmentation, stable endocrinopathies); patients with =< grade peripheral sensory or motor neuropathy are eligible
Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE v, Grade =< or baseline. Subjects with chronic Grade toxicities may be eligible per discretion of the Investigator and Sponsor (eg, Grade chemotherapy-induced neuropathy).
Recovered from toxicities of previous anticancer therapy to CTCAE Grade ? with the exception of alopecia
Toxicities from previous anti-cancer therapies have not resolved to baseline levels or to Grade or less except for alopecia and peripheral neuropathy
Toxicities incurred as a result of previous anti cancer therapy (radiation therapy [RT], chemotherapy, or surgery) must be resolved to ? Grade except for alopecia and anorexia.
Persistent toxicities caused by previous cancer therapy; toxicities should have recovered to =< grade , excluding alopecia and stable chronic grade toxicity that is not overlapping with presumed toxicities of olaparib
Previous toxicities from previous treatment must have resolved to grade or less\r\n* For patients in expansion cohort B, stable grade neuropathy will be allowed
Toxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade as per CTCAE v .
Persistent toxicities (>= CTCAE grade ) caused by previous cancer therapy
The patient has persistent clinically significant toxicities Grade ? from previous chemotherapy (excluding alopecia, nausea, fatigue, and liver function tests (as mandated in the inclusion criteria)).
Subjects with vitiligo or alopecia;
Ongoing toxicity due to a prior therapy, unless returned to baseline or Grade . Grade toxicities (e.g., alopecia or peripheral neuropathy) that are not likely to increase the subject's safety risk while receiving trial treatment may be accepted after Sponsor approval.
Subjects with vitiligo or alopecia;
Resolution of all toxicities related to prior therapies to ? NCI-CTCAE Grade severity, except for alopecia, vitiligo, or endocrinopathies on replacement therapy.
Toxicity from previous anti-cancer therapy that has not recovered to ?Grade prior to enrollment (except for non-clinically significant toxicities, e.g., alopecia, vitiligo). Subjects with existing pneumonitis as a result of radiation are not excluded; however, subjects cannot be oxygen dependent.
Patients must have recovered (to baseline/stabilization) from prior chemo- or radio-therapy and associated acute toxicities must have resolved to a NCI CTCAE v Grade or less, with the exception of alopecia
have discontinued all previous treatments for cancer and recovered from the acute effects of therapy, other than less than or equal to Grade neuropathy or nonserious and nonlife-threatening toxicities such as alopecia, altered taste, and nail changes
Persistent clinically significant toxicities (Grade ?) from previous anticancer therapy (excluding Grade chemotherapy-related neuropathy and alopecia which are permitted). Prior toxicities that resulted in laboratory abnormalities should have resolved to Grade ?. If medical therapy is required for the treatment of a laboratory abnormality, the dose and laboratory value(s) should be stable.
Recovered from all toxicities associated with prior treatment, to acceptable baseline status or grade or less, except for toxicities not considered a safety risk, such as alopecia or vitiligo; peripheral neuropathy must be grade or less
PART B: Previous treatment related side-effects/adverse events must have resolved to at least grade or, at the discretion of the investigator, select stable grade toxicities (e.g. alopecia or fatigue) may be permissible if unchanging in grade for at least months following discussion with the principal investigator (PI)
Recovered from all reversible toxicities related to their previous treatment (other than alopecia) to =< grade or baseline
Recovered from all reversible toxicities related to their previous treatment (other than alopecia) to =< grade or baseline
Recovered from toxicities of previous anticancer therapy to CTCAE Grade ? with the exception of alopecia.
have persistent Grade or greater toxicities from any cause (except alopecia or peripheral neuropathy).
Has not recovered from the adverse effects of previous anti-cancer treatments to pre-treatment baseline or Grade , except for alopecia, anemia (hemoglobin must meet the present study inclusion criterion), and peripheral neuropathy (which must have recovered to ? Grade ).
For Part A only: Participants who did not recover from all clinically significant toxicities (excluding alopecia and hematologic toxicities) of any previous surgery, radiotherapy, targeted therapy, or chemotherapy to less than or equal to Grade
Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or Grade toxicities which, in the opinion of the Investigator, should not exclude the patient.
Patients must have recovered from acute side effects of HSCT, defined as having < grade non-hematological toxicity related to the transplant (exceptions are alopecia and other non-acute toxicities)
Has unresolved toxicities from prior anti-cancer therapies, defined as toxicities (chemotherapy, hormonal treatment, radiation, and/or surgery) not yet resolved to NCI-CTCAE, v, Grade <= or baseline; other than alopecia, skin toxicity (Grade ), according to NCI-CTCAE, v. Subjects with chronic Grade toxicities may be eligible per the discretion of the Investigator and Sponsor (e.g., Grade chemotherapy-induced peripheral neuropathy).
Recovered from toxicities of previous anticancer therapy to CTCAE Grade ? with the exception of alopecia.
Participants not recovered from reversible toxicity of prior anticancer therapy (except toxicities which are not clinically significant such as alopecia, skin discoloration, or Grade neuropathy)
The patient has persistent and clinically significant Grade ? toxicities from induction or consolidation therapy (excluding alopecia, nausea, fatigue, and liver function tests [as mandated in the inclusion criteria]) not readily managed with supportive measures.
No limit to prior therapies with last anti-cancer treatment >= weeks from initiation of protocol-based therapy provided all toxicities (other than alopecia) have resolved to =< grade or baseline
Have not recovered (recovery is defined as CTCAE grade ? ) from the acute toxicities of previous anticancer standard or investigational therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
Have not recovered (recovery is defined as CTCAE grade ? ) from the acute toxicities of previous anticancer standard or investigational therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
Subject that has toxicity from previous anti-cancer therapy must have recovered to ? Grade (except for non-clinically significant toxicities, e.g., alopecia, vitiligo). Subjects with Grade toxicities that are deemed stable or irreversible (e.g. peripheral neuropathy) can be enrolled.
Patients not recovered from any therapy-related toxicities from previous therapies to at least CTCAE ? Grade except in case of liver metastases or Gilbert's Syndrome or alopecia.
Subjects with vitiligo or alopecia;
Residual toxicity due to previous anticancer therapy with no return to baseline or =< Grade (except alopecia) according to CTCAE V.
ongoing grade or greater toxicities due to previous therapies. However, tolerable grade adverse (e.g. neuropathy) events may be allowed at the discretion of the investigator.
Subjects with grade or greater toxicities due to previous therapies (subject to the additional laboratory abnormalities listed below); however, tolerable grade adverse (e.g. residual neuropathy from taxane or oxaliplatin) events may be allowed at the discretion of the investigator
Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ? or baseline. Subjects with chronic Grade toxicities may be eligible per the discretion of the Investigator after consultation with the Sponsor Medical Monitor or designee (eg, Grade chemotherapy-induced neuropathy).
Patients who have received prior chemotherapy, other ALK inhibitors, biologic therapy, or other investigational agents, must have recovered from all toxicities related to prior anticancer therapies to grade ? (CTCAE v .) prior to starting study drug. Patients with grade ? peripheral neuropathy or any grade of alopecia, nail changes or skin changes are allowed to enter the study.
Recovered from all reversible toxicities related to their previous treatment (other than alopecia) to =< grade or baseline; exceptions to this criteria may be allowed at the discretion of the UNC PI for toxicities that are not expected to be exacerbated by pembrolizumab or nab-paclitaxel