Unresolved toxicity (i.e., > grade 1 or above baseline) due to previously administered agents; exception includes: subjects with =< grade 2 neuropathy are eligible for the study
Unresolved acute toxicity from prior anticancer therapy
Unresolved toxicity from prior chemotherapy (subjects must be recovered to ? Grade 1 toxicity from previous anticancer treatments or previous investigational products.
Unresolved chronic toxicity > grade 1 from prior therapy
Unresolved toxicity higher than CTCAE (v. 4.03) Grade 1 attributed to any prior therapy/procedure excluding alopecia and hypothyroidism;
Unresolved toxicity higher than CTCAE grade 1 attributed to any prior therapy/procedure excluding alopecia
Unresolved CTCAE >Grade 2 toxicity (other than stable toxicity) from previous anti-cancer therapy excluding alopecia.
Have any unresolved chronic toxicity with CTC AE grade >= 2, from previous anti-NF1 therapy, except for alopecia
Patients with unresolved > Grade 1 toxicity associated with any prior antineoplastic therapy
Patients with unresolved > Grade 1 toxicity associated with any prior antineoplastic therapy
Persistent, unresolved ?Grade 2 clinically significant drug-related toxicity (except alopecia, erectile impotence, hot flashes, libido, neuropathy) associated with previous treatment
Any unresolved toxicity (>= CTCAE grade 2) from previous anti-cancer therapy, excluding alopecia
Any unresolved >= grade 2 pulmonary toxicity from previous anti-cancer therapy
Any unresolved grade 2 or higher toxicity from previous anti-cancer therapy
Unresolved grade 2 or greater toxicity from most recent treatment, including chemotherapy, hormonal therapy, or radiotherapy, at the time of study enrollment
Unresolved toxicity higher than NCI-CTCAE version 4.03 grade 1 attributed to any prior therapy/procedure excluding anemia or neuropathy grade 2 and alopecia of any grade
Have any unresolved chronic toxicity with CTCAE grade >= 2, from previous anti-NF1 therapy, except for alopecia
Patients who have unresolved toxicity from all radiation, adjuvant/neoadjuvant chemotherapy, other targeted treatment including investigational treatment (exception of alopecia and ? Grade 2 peripheral neuropathy) according to NCI-CTCAE v4.03 criteria
Unresolved toxicity higher than CTCAE grade 1 attributed to any prior therapy/procedure excluding alopecia
Unresolved toxicity from previous anticancer therapy or incomplete recovery from surgery
Any unresolved toxicity > CTCAE grade 2 despite optimal care/support, from previous anti-cancer therapy, except for alopecia, within 7 days prior to Cycle 1, day 1
Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or prior anti-cancer treatment
Any unresolved toxicity ? Grade 2 from previous anticancer therapy except for stable chronic toxicities (? Grade 2) not expected to resolve.
Patients with unresolved > Grade 1 toxicity associated with any prior antineoplastic therapy
Unresolved > Grade 1 toxicity associated with any prior antineoplastic therapy
Unresolved toxicity higher than CTCAE grade 1 attributed to any prior therapy/procedure, excluding alopecia
Subjects experiencing unresolved toxicity of previous antitumor therapy which is CTCAE grade > 1 before the start of study treatment, except for alopecia or hemoglobin >= 9.0 g/dL or >= 5.6 mmol/L
Any unresolved toxicity ? Grade 2 (except stable Grade 2 peripheral neuropathy or alopecia) from previous anticancer therapy
Subject has any unresolved toxicity Grade > 1 from previous anti-cancer therapy
Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies.
Any unresolved toxicity greater than Common Toxicity Criteria (CTC) grade 1 from previous anti-cancer therapy
Any unresolved toxicity > Common Toxicity Criteria Grade 1 (except alopecia) from previous anticancer therapy (including radiotherapy)
Any unresolved toxicity NCI CTCAE Grade ?2 from previous anticancer therapy
Unresolved toxicity greater than CTCAE (version 4.0) grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity =< grade 2
Any unresolved toxicity NCI CTCAE Grade ?2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criterion;
Any unresolved toxicity NCI CTCAE Grade ?2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criterion
Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy.
Unresolved toxicity higher attributed to any prior therapy/procedure excluding alopecia, hypothyroidism and oxaliplatin- induced neurotoxicity ? Grade 2 for at least 14 days;
Any unresolved toxicity CTCAE >Grade 2 from previous anti-cancer therapy.
Unresolved toxicity higher than CTCAE v. 4.0 grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin-induced neurotoxicity (which must be =< grade 2)
Any unresolved toxicity greater or equal to grade 2 from previous anticancer therapy, except for stable chronic toxicities not expected to resolve
Patients with any unresolved toxicity greater than Grade 1 from previous anticancer therapy
Unresolved toxicity higher than CTCAE v. 4.0 grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin-induced neurotoxicity (which must be =< grade 2)
Any unresolved toxicity (> CTCAE grade 2) from previous anti-cancer therapy
Has any unresolved toxicity ? Grade 2 from previous anticancer therapy
Subjects experiencing unresolved toxicity of previous antitumor therapy (excluding alopecia) which is CTCAE Grade >1 at screening
Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2)
Any unresolved chronic toxicity greater then Common Terminology Criteria (CTC) grade 2 from previous anticancer therapy
Unresolved clinically significant toxicity greater than Grade 2 from previous anti-cancer therapy
Have unresolved toxicity from previous treatment or previous investigational agents; excluding alopecia; clinical judgment by the investigator is allowed to determine if grade 1 fatigue at screening is residual toxicity from prior treatment or is a symptom of the patient’s general condition or disease; the investigator and medical monitor will discuss the eligibility of patients with baseline toxicity
Has unresolved toxicity of greater than or equal to CTCAE Grade 1 attributed to any prior therapies
Unresolved toxicity higher than NCI-CTCAE version 4.0 Grade 1 attributed to any prior therapy/procedure (excluding alopecia or anemia or grade 2 neuropathy that is not reversible due to oxaliplatin)
Any unresolved >=Grade 2 (per CTCAE v 4.0) toxicity from previous anti-cancer therapy at the time of enrollment, except alopecia or Grade 2 anemia (if hemoglobin is >9.0 g/dL)
Unresolved, clinically significant toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy
Grade 2 or greater unresolved toxicity from prior antineoplastic therapy
Any unresolved toxicity greater than CTCAE grade 1 (except alopecia, and certain other unresolved CTCAE grade 2 toxicities including bone marrow hypocellularity, lymphopenia, infusion-related reaction, infusion site extravasation, injection site reaction, portal vein hypertension, obesity) from previous anti-cancer therapy; patients with grade 1 neuropathy will be evaluated on a case by case basis for entry into study; pre-chemotherapy medical conditions will be taken into consideration
Patients with unresolved grade > 2 non-hematologic toxicity from previous therapy; patients with grade 2 toxicity will be eligible at the discretion of the Principal Investigator (PI)
Patient experiencing unresolved toxicity ? CTCAE grade 2 (except alopecia) from previous agents.
Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy (except alopecia)
Patient has received other chemotherapeutic, hormonal, or investigational anti cancer agents that are outside of the timeframe described above and thus would be allowed in the study, but has toxicity that is unresolved (i.e., toxicity has resolved to Grade ? 1 or is deemed irreversible)
Unresolved toxicity from other agents; participants with unresolved or unstable Common Toxicity Criteria Adverse Event version 4 (CTCAE v4) grade 2 or greater toxicity from prior administration of another anti-cancer treatment are not eligible
Unresolved chronic toxicity of previous AML treatment
Unresolved specific chronic toxicity of previous treatment of grade > 1 except for alopecia or hemoglobin ?9.0 g/dL (or ?5.6 mmol/L)
Persistent clinically significant toxicities (>= CTCAE version [v.] 4.0 grade 2) caused by previous cancer therapy, with the exception of alopecia
Unresolved toxicities from prior anticancer therapy that have not resolved to CTCAE, version 4.0, grade =< 1 or baseline, with the exception of alopecia and laboratory values listed
Subject has toxicity from previous anticancer therapy that has not recovered to ? Grade 1 or to their baseline level of organ function prior to enrollment (except for non-clinically significant toxicities, e.g., alopecia, vitiligo).
Persistent toxicities (>= CTCAE grade 2) with the exception of alopecia, caused by previous cancer therapy
Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE v4, grade =< 1 or baseline. Subjects with chronic grade 2 toxicities may be eligible per the discretion of the Investigator and Sponsor (eg, grade 2 chemotherapy-induced neuropathy).
Has unresolved toxicities from previous anticancer therapy
Persistent toxicities (> CTCAE grade 2) with the exception of alopecia, caused by previous cancer therapy
Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE v4, Grade =<1 or baseline. Subjects with chronic Grade 2 toxicities may be eligible per discretion of the Investigator and Sponsor (eg, Grade 2 chemotherapy-induced neuropathy).
Use of investigational agents within 30 days or any anticancer therapy within 2 weeks prior to entering this study with the exception of hydroxyurea; the patient must have recovered from all acute toxicities from any previous therapy
Unresolved toxicities from previous anticancer therapy.
Recovered from toxicities of previous anticancer therapy to CTCAE Grade ? 1
Recovered from toxicities of previous anticancer therapy to CTCAE Grade ? 1 with the exception of alopecia
Use of investigational agents within 30 days or any anticancer therapy for this malignancy within 2 weeks before study entry with the exception of intrathecal (IT) therapy, hydroxyurea, or low-dose cytarabine as stated above; the patient must have recovered from all acute toxicities from any previous therapy
Prior chemotherapy, with the exception of hydroxyurea or low-dose cytarabine as stated above; the patient must have recovered from all acute toxicities from any previous therapy
Persistent toxicities (>= CTCAE grade 2) caused by previous cancer therapy
Unresolved toxicities from prior anticancer therapy
Unresolved toxicities from previous anticancer therapy
Recovered from toxicities related to prior anticancer therapy to NCI CTCAE v 4.0 grade ?1.
Use of investigational agents within 2 weeks or any anticancer therapy within 2 weeks before study entry; the patient must have recovered from all acute toxicities from any previous therapy
Unresolved toxicities from prior therapy
Significant unresolved toxicities from previous anticancer therapy that have not resolved, or have not stabilized at a new baseline
Unresolved toxicities from prior anticancer therapy
Recovered from toxicities of previous anticancer therapy
Any anticancer therapy within 3 weeks before study entry; this exclusion does not apply to corticosteroid therapy; the patient must have recovered from all acute toxicities from any previous therapy
Use of investigational agents within 30 days or any anticancer therapy for this malignancy within 2 weeks before study entry with the exception of IT therapy, hydroxyurea, or low-dose cytarabine as stated above; the patient must have recovered from all acute toxicities from any previous therapy
Recovered from toxicities of previous anticancer therapy to CTCAE Grade ? 1 with the exception of alopecia.
Unresolved toxicities from prior anticancer therapy.
Recovered from toxicities of previous anticancer therapy to CTCAE Grade ? 1 with the exception of alopecia.
Have not recovered (recovery is defined as CTCAE grade ? 1) 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 ? 1) from the acute toxicities of previous anticancer standard or investigational therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
Unresolved toxicities from prior therapy
Has unresolved toxicities from previous anticancer therapy
Patient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade < 1 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study)
Failure to recover from all adverse events/toxicities related to prior anticancer therapies to grade 1 per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03; NOTE: Exception: patients with any grade of alopecia are allowed to enter the study
Participants who have had chemotherapy within 14 days prior registration or those who have not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade =< 1 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study); there is no washout period required for trastuzumab or for endocrine therapy; however subjects who received fulvestrant immediately prior to this trial should wait at least 28 days before receiving their first dose of fulvestrant on study
Patient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-CTCAE version 4.03 grade < 1 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study)
Patient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 to less than or equal to grade 1 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study)
Patient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 grade =< 1 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study)
Must have received prior therapy with a MET inhibitor; patients must have recovered from all toxicities related to prior anticancer therapies to grade =< 1 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.0); patients with any grade of alopecia are allowed to enter the study
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 ?1 (CTCAE v 4.03). Patients with grade ? 2 peripheral neuropathy or any grade of alopecia, fatigue, nail changes or skin changes are allowed to enter the study
Patients may have received prior chemotherapy, crizotinib (other ALK inhibitors are not allowed), biologic therapy or other investigational agents. Patients must have recovered from all toxicities related to prior anticancer therapies to grade ? 1 (CTCAE v 4.03). Patients with any grade of alopecia are allowed to enter the study.
Patient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade =< 1 (Exception to this criterion: patients with any grade of alopecia are allowed to enter the study)
Patients must have recovered from all clinically relevant toxicities related to prior anticancer therapies to =< grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03); exception to this criterion: patients with any grade of alopecia are allowed to enter the treatment
Patient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade < 1 (exception to this criterion: patients with any degree of alopecia are allowed to enter the study)
Patients must have recovered from all toxicities related to any prior anticancer therapies to =< grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03), provided that any concomitant medication is given prior to initiation of treatment with ceritinib; exception to this criterion: patients with any grade of alopecia are allowed to enter the treatment
Patients must have recovered from all toxicities related to prior anticancer therapies to grade ? 1 (CTCAE v 4.03). Patients with any grade of alopecia are allowed to enter the study.
Patients must have recovered from all toxicities related to prior anticancer therapies to =< grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03), provided that any concomitant medication is given prior to initiation of treatment with ceritinib; exception to this criterion: patients with any grade of alopecia are allowed to enter the treatment
Patient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade < 1 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study)
Patient has not recovered from all toxicities related to prior anticancer therapies to grade 1 per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study)
Patient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade < 3 (exception to this criterion: patients with any grade of alopecia or neuropathy are allowed to enter the study)
Patient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade =< 1 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study).
Patients must have recovered from all toxicities related to prior anticancer therapies to grade =< 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03) provided that concomitant medication is given prior to initiation of treatment with LDK378 [ceritinib], except for patients with grade 2 nausea/vomiting and/or grade 2 diarrhea despite optimal supportive therapy who will not be allowed to participate in the study; additionally, patients with any grade of alopecia are allowed on treatment
Patients must have recovered from all toxicities related to prior anticancer therapies to =< grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03); exception to this criterion: patients with any grade of alopecia are allowed to enter the treatment
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 ? 1 (CTCAE v 4.03) prior to starting study drug. Patients with grade ? 2 peripheral neuropathy or any grade of alopecia, nail changes or skin changes are allowed to enter the study.
Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\r\n* Patients with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician; patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the study physician
Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\r\n* Patients with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician.\r\n* Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the study physician.
Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria: -- Subjects with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the principal investigator.-- Subjects with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the principal investigator.
Any toxicity (> CTCAE version 4 grade 3) from previous anti-cancer therapy that has not resolved to a grade 1; persistence of clinically relevant therapy related toxicity from previous chemo and/or radiotherapy; patients with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy, alopecia)
Any unresolved toxicity NCI Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\r\n* Subjects with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the principal investigator\r\n* Subjects with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the principal investigator
Any unresolved toxicity (> CTCAE version [v]4 grade 2) from previous anti-cancer therapy; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripheral neuropathy)
Any unresolved toxicity (Common Terminology Criteria for Adverse Events [CTCAE] grade >= 2) from previous anti-cancer therapy. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy).
Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria; subjects with grade ? 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician; subjects with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the study physician
Any unresolved toxicity (? Common Terminology Criteria for Adverse Events [CTCAE] grade 2) from previous anti-cancer therapy. NOTE: Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy)
Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE grade =< 1 with the exception of alopecia and laboratory values listed per the inclusion criteria. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (eg, hearing loss)
Presence of unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v4.03 grade 0 or 1 with the exception of alopecia; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by regorafenib (e.g. hearing loss, neuropathy) may be included after consultation with the principal investigator
Any unresolved toxicity (> Common Terminology Criteria for Adverse Events [CTCAE] grade 1) from previous anti-cancer therapy, excluding alopecia. Subjects with irreversible toxicity greater than grade 1 that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy).
Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 2 from previous anti-cancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\r\n* Patients with grade >= 2 neuropathy will be evaluated on a case-by-case basis and may be included after consultation with the study physician\r\n* Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with their assigned investigational product (IP) (e.g., hearing loss) may be included after consultation with the study physician
Any unresolved toxicity (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2) from previous anti-cancer therapy; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy)
Is still experiencing toxicity related to prior treatment and assessed as Common Terminology Criteria for Adverse Events (CTCAE) grade > 1. Exceptions are alopecia and/or anorexia. The eligibility of patients who are still experiencing irreversible toxicity that is not reasonably expected to be exacerbated by the study drugs in this study (eg, hearing loss) must be reviewed and approved by both the principal investigator and medical monitor
Any unresolved toxicity (Common Terminology Criteria for Adverse Events [CTCAE] grade >= 2) from previous anti-cancer therapy; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy)
Any unresolved toxicity (Common Terminology Criteria for Adverse Events [CTCAE] grade 2 or above) from previous anti-cancer therapy; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy)
Unresolved toxicities from prior anticancer therapy, defined as having not resolved to National Cancer Institute’s (NCI’s) Common Terminology Criteria for Adverse Events (CTCAE) (NCI CTCAE version [v]4.03) grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria with the exception of alopecia; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by nivolumab may be included (eg, hearing loss) after consultation with the principal investigator
Any unresolved Common Terminology Criteria for Adverse Events (CTCAE) grade >2 toxicity from previous anti-cancer therapy; patients with irreversible toxicity that is not reasonably expected to be exacerbated by study therapy (eg, hearing loss) may be enrolled after discussion with the principal investigators
Patients are ineligible if they have unresolved toxicities from prior anticancer therapy, defined as having not resolved to National Cancer Institute (NCI) CTCAE version 4.03 grade 0 or 1 with the exception of alopecia and laboratory values listed per the inclusion criteria\r\n* Note: Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by any of the investigational products may be included (eg, hearing loss) after consultation with the PI and Northwestern University (NU) Quality Assurance Monitor (QAM)
Any unresolved toxicity (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2) from previous anti-cancer therapy; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy)
Unresolved toxicities from prior anticancer therapy, defined as having not resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 grade 0 or 1 with the exception of alopecia and laboratory values listed per the inclusion criteria; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by any of the investigational products may be included (eg, hearing loss) after consultation with the study chair
Unresolved toxicities from prior anticancer therapy, defined as having not resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03 grade 0 or 1 with the exception of alopecia and laboratory values listed per the inclusion criteria; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by durvalumab and tremelimumab may be included (e.g. hearing loss) after consultation with the principal investigator
Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria: a) patients with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician; b) patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the study physician
Any unresolved toxicity (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2) from previous anti-cancer therapy; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy)
Full recovery from the acute effects of prior cancer treatments, defined as effects having resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade 0 or 1 with the exception of alopecia and certain laboratory values as listed above; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by MEDI4736 and tremelimumab may be included (eg, hearing loss, neuropathy) upon approval of the principal investigator (PI)
Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\r\n* Patients with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the treating physician and/or PI\r\n* Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the treating physician and/or PI
Any unresolved toxicity of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2, including electrolyte abnormalities, from previous anticancer therapy, with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\r\n* Patients with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician\r\n* Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the study physician
Any unresolved toxicity (non-immune mediated) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia\r\n* However, patients with irreversible toxicity not reasonably expected to be exacerbated by the treatment with durvalumab + trabectedin may be included only after consultation with the study physician
Full recovery from the acute effects of prior treatments, defined as effects having resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03 grade 0 or 1 with the exception of alopecia and certain laboratory values as outlined below; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by durvalumab and tremelimumab may be included (e.g., hearing loss, neuropathy) upon approval of the principal investigator (PI)
Any unresolved toxicity (CTCAE grade < 2) from previous anti-cancer therapy; (subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy)
Any unresolved toxicity (National Cancer Institute Common Terminology Criteria for Adverse Event [CTCAE] version 4.03 [v4.03]) grade 2 or greater from previous anticancer therapy with the exception of alopecia, and the laboratory values defined in the inclusion criterion 8. Hearing loss of grade 3 or lower and peripheral neuropathy of grade 2 or lower is allowed. Subjects with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician. Subjects with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the study physician.
Any unresolved toxicity (> Common Terminology Criteria for Adverse Events [CTCAE] grade 1) from previous anti-cancer therapy with the exception of alopecia; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripheral neuropathy)
Any unresolved toxicity (> CTCAE grade 2) from previous anti-cancer therapy; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy)
Any unresolved toxicity (> CTCAE grade 2) from previous anti-cancer therapy; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., alopecia, hearing loss, peripheral neuropathy)
Any unresolved clinically significant treatment related toxicity of >= grade 1 intensity, as assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), from previous anti-cancer therapy; patients with irreversible toxicity (eg, hearing loss, peripherally neuropathy) or reversible toxicity (eg, alopecia) that is not reasonably expected to be exacerbated by the investigational product and is not expected to interfere with study participation may be included
Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v4.03 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria with the exception of alopecia. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by MEDI0680 (AMP-514) may be included (eg, hearing loss) after consultation with the MedImmune medical monitor
Any unresolved toxicity (> CTCAE grade 2) from previous anti-cancer therapy; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy)
Any unresolved toxicity from previous anti-cancer therapy must have resolved to at least =< grade 1 (or baseline) at time of enrollment\r\n* Patients with irreversible toxicity that is not reasonably expected to be exacerbated by treatment with durvalumab and tremelimumab may be included after consultation with the principal investigator or co-principal investigator (e.g. alopecia, hearing loss, peripheral neuropathy)
The participant has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except =< grade 2 alopecia, neuropathy, and other non-clinically significant adverse events (AEs)
Patients who have not recovered from adverse events due to prior anti-cancer therapy to grade 1 or baseline; patients with stable, controlled grade 2 adverse events (AEs) such as peripheral neuropathy, hypothyroidism, hypertension, adrenal insufficiency or alopecia are allowed after discussing with the PI
Patients must have recovered from all clinically relevant adverse events to grade 1 or baseline due to previous agents administered (except alopecia)
The subjects who have not recovered to baseline or CTCAE ? Grade 1 from related toxicity to all prior therapies will be excluded. Patients with Non-serious adverse events such as alopecia, fatigue, weakness, loss of appetite and nausea that are non-significant will not be excluded.
Patients must have recovered from adverse events (greater than grade 1) due to prior anticancer therapy, except for stable chronic toxicities such as alopecia
The participant has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
The patient has not recovered to grade ? 1 from adverse events (AEs) due to investigational drugs or other medications, which were administered more than 4 weeks prior to the first dose of study drug.
The subject has not recovered to baseline, Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies for RCC or to a level permitted under other sections of the eligibility criteria except alopecia and other non-clinically significant adverse events (AEs)
Patients who have received palliative radiotherapy within 2 weeks of study entry and have not recovered to grade 1 or baseline from associated toxicities. Note: Patients may receive palliative radiation once enrolled on study. The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies, including surgery, except alopecia and other non-clinically significant adverse events (AEs).
GENERAL: Adverse events (AEs) from prior anticancer therapy that have not resolved to grade =< 1 except for alopecia.
The subject has not recovered to baseline or CTCAE =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant AEs.
Adverse events from prior anticancer therapy that have not resolved to grade =< 1 except for alopecia.
Patients must have recovered from treatment toxicities to =< grade 1 or to their pretreatment levels except for adverse events (AEs) that in the investigator’s judgment do not constitute a safety risk for the patient
Adverse events (AEs) from prior anticancer therapy that have not resolved to grade =< 1 except for alopecia and neuropathy
Adverse events (AEs) from prior anticancer therapy that have not resolved to grade =< 1 except for alopecia
Adverse events (AEs) from prior anti-cancer therapy that have not resolved to grade =< 1 except for alopecia and neuropathy
Adverse events (AEs) from prior anticancer therapy that have not resolved to grade =< 1 except for alopecia
The subject has not recovered to baseline or Common Terminology Criteria For Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
Patients who have not recovered from adverse events attributed to prior anti-cancer therapy (i.e. have residual toxicities > grade 1, except for alopecia, neuropathy, lymphocytopenia and other non-clinically significant adverse events)
Adverse events (AEs) from prior anticancer therapy that have not resolved to grade ? 1 except for alopecia
Adverse events from previous cancer therapies (excluding alopecia) must have recovered to grade 1 (CTCAE, most recent version). Stable grade 2 AEs such as endocrine conditions are allowed, and other chronic stable AEs may be considered on a case by case basis by the Principal Investigator.
Participant has unresolved adverse events greater than grade 1 from prior anticancer therapy except for alopecia.
Adverse events from prior anticancer therapy that have not resolved to grade =< 1 except for alopecia
Must have completely recovered or recovered to baseline prior to screening from any prior adverse events (AEs) occurring while receiving prior immunotherapy.
The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
mCRPC EXPANSION COHORT: The patient has not recovered to baseline or CTCAE =< grade 1 from toxicity due to all prior therapies, including surgery, except alopecia and other non-clinically significant adverse events (AEs)
The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
Subject has unresolved adverse events >= Grade 2 from prior anticancer therapy, except for alopecia or anemia.
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nThe patient has not recovered to baseline or CTCAE =< grade 1 from toxicity due to all prior therapies, including surgery, except alopecia and other non-clinically significant adverse events (AEs)
The subject has not recovered to baseline or CTCAE =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
Subjects must be competent to report adverse events (AEs), understand the drug dosing schedule and use of medications to control AEs
The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or computerized tomography (CT) scan; the subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< Grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs) (e.g. albumin)
Must have recovered (? Grade 2 or at pretreatment baseline) from adverse events (AEs) from previously administered therapies except for stable chronic toxicities (? Grade 2) not expected to resolve.
Adverse events (AEs) from prior anticancer therapy that have not resolved to grade =< 1 except for alopecia.
The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from related toxicity to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
The subject has recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicities related to prior treatment, except alopecia, lymphopenia, other non-clinically significant adverse events (AEs)
Adverse events (AEs) from prior anticancer therapy that have not resolved to grade =< 1 except for alopecia
Common Terminology Criteria for Adverse Events (CTCAE) recovered to baseline or CTCAE =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
Prior anti-cancer therapy (e.g., biologic or other targeted therapy, chemotherapy, hormonal therapy) within 2 weeks prior to day 1 if the patient has recovered from all adverse events (AEs) to grade 1 except for alopecia
Has not recovered (i.e., AE ? Grade 1 or at Baseline) from AEs due to a previously administered agent.
Resolution of any adverse events (AEs) from prior treatments must be resolved to baseline or grade =< 1 at enrollment (with the exception of alopecia), neuropathy, and ototoxicity (i.e., AEs that are not expected to improve within the washout period)
Adverse events from prior anti-cancer therapy that have not resolved to Grade <= 1 except for alopecia
The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
Adverse events (AEs) from prior anticancer therapy that have not resolved to grade =< 1 except for alopecia
Have current or prior history of infection or clinically significant adverse events (AEs) associated with an exogenous implant(s) or device(s) that cannot be easily removed
Subjects who have had any anticancer treatment prior to entering the study and have not recovered to baseline (except alopecia) or ? Grade 1 AEs, or deemed irreversible from the effects of prior cancer therapy. AEs > Grade 1 that are not considered a safety risk by the Sponsor and investigator may be allowed upon agreement with both, including residual neuropathy.
Recovery from effects of recent treatment to baseline or CTCAE =< grade 1 toxicity from all prior therapies except alopecia and other non-clinically significant adverse events (AEs), unless the principal investigator (PI) determination is that the electrolyte imbalance is a result of the disease process
Adverse events (AEs) from prior anticancer therapy that have not resolved to grade ? 1 except for alopecia
Subjects who have had any anticancer treatment prior to entering the study and have not recovered to baseline (except alopecia) or? Grade 1 AEs, or deemed irreversible from the effects of prior cancer therapy. AEs > Grade 1 that are not considered a safety risk by the Sponsor and investigator may be allowed upon agreement with both.
The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies, including surgery, except alopecia and other non-clinically significant adverse events (AEs)
The participant has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
Last anti-cancer treatment (including any investigational drug) >= 2 weeks from initiation of protocol-based therapy, and provided all adverse events (AEs) (other than alopecia) have resolved to =< grade 1 at baseline
Adverse events (AEs) from prior anticancer therapy that have not resolved to grade =< 1 except for alopecia
History of Grade ?3 infusion-related adverse events (AEs) or hypersensitivity to NEOD001
History of Grade ?3 infusion-associated adverse events (AEs) or hypersensitivities to NEOD001 or any of its excipients
The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs) defined as lab elevation with no associated symptoms or sequelae
The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
Subjects who are able and agree to report adverse events (AEs) during the required reporting period.
Recovery from prior therapy toxicity, defined as resolution of all treatment-related adverse events (AEs) to Grade ? 1 or pre-treatment baseline (except alopecia and lymphopenia).
Subjects who have had any anticancer treatment prior to entering the study and have not recovered to baseline (except alopecia) or ? Grade 1 AEs, or deemed irreversible from the effects of prior cancer therapy. AEs > Grade 1 that are not considered a safety risk by the Sponsor and Investigator may be allowed upon agreement with both.
Subjects who have had any anticancer treatment prior to entering the study and have not recovered to baseline (except alopecia) or ? Grade 1 AEs, or deemed irreversible from the effects of prior cancer therapy. AEs > Grade 1 that are not considered a safety risk by the Sponsor and investigator may be allowed upon agreement with both.
Patients who have had anticancer therapy, including kinase inhibitors or any investigational agent within 4 weeks or 5 half-lives (whichever is shorter) (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered to baseline from adverse events (except alopecia and other non-clinically significant adverse events [AEs]); patients who have received prior cabozantinib or inhibitors of c-MET or HGF are ineligible
The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
Unresolved adverse events >= Grade 2 from prior anticancer therapy, except for alopecia.
Has not recovered (e.g., to ? Grade 1 or to baseline) from AEs due to a previously administered therapy.