Platelets >= 100,000/mm^3, equivalent to CTCAE v 3.0 grade 0-1
Bilirubin =< 1.5 x ULN (CTCAE v 3.0 grade 1)
Recovered to ? grade 1 NCI CTCAE version 4.0 from toxicity of prior chemotherapy or biologic therapy administered more than 4 weeks earlier.
Presence of ? CTCAE grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if ? CTCAE grade 3) due to prior cancer therapy
Neuropathy, grade 2 or greater by NCI-CTCAE, v 4.0
Ongoing adverse effects from prior systemic treatment > NCI CTCAE Grade 1 (with the exception of Grade 2 alopecia)
Ongoing cardiac dysrhythmias of NCI CTCAE v4.03 Grade 2 or prolongation of the QTcF interval to >480 msec.
Presence of ? CTCAE grade 2 toxicity (except alopecia and ototoxicity, which are excluded if ? CTCAE grade 3) due to prior cancer therapy.
Ongoing infection > grade 2 NCI-CTCAE v4.0
Any Grade >1 (according to the NCI CTCAE 4.03) adverse reaction unresolved from previous treatments and not readily managed and controlled with supportive care.
Grade 2 to 4 peripheral neuropathy (NCI CTCAE v 4.03).
Any ongoing cardiac dysrhythmias of National Cancer Institute (NCI) CTCAE grade > 2, NCI CTCAE grade 4 atrial fibrillation, or corrected QC interval per Fridericia's formula (QTcF) interval > 470 msec, except for documented right bundle branch block, at screening
History or presence of clinically significant ventricular or atrial dysrhythmia >Grade 2 per NCI CTCAE v4.0
Significant recent bleeding history defined as NCI CTCAE grade ?2 within the last 3 months, unless precipitated by an inciting event (e.g., surgery, trauma, injury)
Any history of CTCAE grade ?2 cardiac dysrhythmias within the last 6 months. Patients with non-QTc CTCAE grade 2 cardiac dysrhythmias may be considered for inclusion, with the approval of the medical monitor, if the dysrhythmias are stable, asymptomatic, and unlikely to affect patient safety.
Ongoing infection > grade 2 NCI-CTCAE v4.0
Ongoing infection > grade 2 NCI-CTCAE version (v) 4.0
Patients cannot have experienced a significant (CTCAE Grade 3 or 4 with or without neutropenia) infection within 2 weeks of their first dose of MT-3724.
Serum bilirubin less than or equal to 1.5 x ULN (CTCAE v3.0 grade 1)
Have Grade 3 or 4 peripheral neuropathy per NCI-CTCAE Version 4.0.
Subject has symptomatic cardiac disorders (CTCAE v. 4.03 Grade 3 and 4)
Afebrile (<38°C per CTCAE v4.03);
Patient has not recovered from toxicity from prior immune checkpoint inhibitor therapy. Recovery is defined as ? NCI-CTCAE Grade 1, except for liver function test levels which must be <Grade 1.
Afebrile (<38°C per CTCAE v4.03);
(Bevacizumab-related exclusion) Any previous venous thromboembolism > NCI CTCAE grade 3
serum potassium NCI-CTCAE version 4.03 Grade <2;
serum calcium NCI-CTCAE version 4.03 Grade <2;
serum magnesium NCI-CTCAE version 4.03 Grade <2;
Evidence of peripheral neuropathy > grade 1 by NCI-CTCAE version 4.03;
Ongoing infection > grade 2 NCI-CTCAE v4.0
Subjects with baseline symptoms of fever and/or cough and/or shortness of breath and/or wheezing and/or fatigue grade >= 2 (CTCAE version [v]4.0)
Patients with hypertriglyceridemia defined as >1000 mg/dL (CTCAE Grade 4).
Otherwise, all toxicity at study entry < Grade 1 by NCI CTCAE v4.00 (Patients with ? Grade 2 neuropathy are eligible).
Grade 3-4 electrolyte abnormalities (CTCAE v 4.03) except sodium, which must be ?126 mmol/L.
Serum creatinine =< 1.5 X ULN (CTCAE grade 1 baseline)
Patients who have active clinically serious infection > CTCAE grade 2 are not eligible
Serum creatinine =< 1.5 x ULN (CTCAE grade 1 baseline)
Patients exhibiting baseline grade 3 or 4 by CTCAE criteria are excluded
Ongoing infection > Grade 2 NCI-CTCAE v 4.03
Creatinine less than 1.5 x ULN (CTCAE Grade 1)
Bilirubin less than 1.5 x ULN (CTCAE Grade 1)
Bilirubin less than or equal to 1.5 x ULN (CTCAE v4 grade 1)
Cardiac dysrhythmias of NCI CTCAE grade >= 2 within the last 28 days
Serious uncontrolled infection > grade 2 (CTCAE v4.0)
Serious uncontrolled infection > grade 2 (CTCAE v4.0)
At least one clinical symptom probably or definitely attributed to KSHV-MCD\r\n* Intermittent or persistent fever for at least 1 week (> 38 Celsius degree [C])\r\n* Fatigue (Common Terminology Criteria for Adverse Events [CTCAE] grade 2 or greater)\r\n* Gastrointestinal symptoms (includes nausea and anorexia) (CTCAE grade 1 or greater)\r\n* Respiratory symptoms (includes cough and airway hyperreactivity) (CTCAE grade 1 or greater)
Clinical relevant AEs or laboratory results related to previous anti-neoplastic therapy have not resolved to a NCI-CTCAE grade ?1.
Presence of neuropathy > Grade 1 (NCI CTC, Version 4.0)
Presence of neuropathy > Grade 1 (NCI CTC, Version 4.0)
Subjects with neuropathy grade ?2 based on CTCAE v4.03 at the time of study entry
Presence of any CTCAE grade 2 or greater toxicity
Ongoing infection > grade 2 NCI-CTCAE v4.0
Recovery to baseline or ? Grade 1 CTCAE ver.4.0
Patients with ataxia >= CTCAE grade 2 are ineligible
Grade 3-4 electrolyte abnormalities (CTCAE, v. 4):
Triglycerides < CTCAE grade 2
Subjects who have an active clinically serious infection of CTCAE grade >= 2
Bilirubin less than or equal to 1.5 x ULN (CTEP CTCAE version 4.0, grade 1)
Ongoing acute adverse effects from prior anticancer or investigational therapy > NCI CTCAE Grade 1
Serum creatinine ? 1.5 X ULN (CTCAE Grade 1 baseline)
Ongoing clinical adverse events NCI CTCAE Grade >2 resulting from prior cancer therapies
All prior treatment- related toxicities must be CTCAE (Version 4.0) <=Grade 1 (except alopecia and peripheral neuropathy) at the time of treatment allocation [NCI-CTCAE, 2009].
Neuropathy >NCI-CTCAE Grade 1.
Evidence of significant CNS haemorrhage i.e. CTCAE grade 2 or above;
All AEs resulting from prior chemotherapy, surgery, or radiotherapy, must have resolved to at least NCI-CTCAE (v. 4.03) Grade 1 (except for laboratory parameters outlined below).
Ongoing infection > grade 2 NCI-CTCAE v 4.0
Ongoing infection > Grade 2 NCI-CTCAE v4.03.
Neuropathy, grade 2 or greater by NCI-CTCAE, v. 4.0
Presence of ? CTCAE grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if ? CTCAE grade 3) due to prior therapy.
Presence of NCI CTCAE ? grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if ? NCI CTCAE grade 3) due to prior cancer therapy
Subjects with known Gilbert's syndrome who have serum bilirubin ? 3 x ULN (NCI CTCAE v4.03 Grade 2) may be enrolled.
Any reversible treatment-related toxicity that has not resolved to NCI CTCAE grade =< 1 except neuropathy
Ongoing infection > grade 2 NCI-CTCAE v4.0
? CTCAE Grade 3 anemia, OR
? CTCAE Grade 3 hematoma (bleed)
CTCAE v4.0 grade 3 or 4 anorexia or nausea related to metastatic disease.
Clinically significant bleeding NCI-CTCAE version 4.0 Grade 3 or higher within 30 days before randomization.
Current NCI CTCAE (Version 4.0) Grade >/= 2 peripheral neuropathy
Neuropathy, grade 2 or greater by NCI-CTCAE, v. 4.0
Bilirubin =< 1.5 x ULN, CTCAE grade 1
Serum albumin greater or equal to 3 g/dl (CTCAE 4.0 grade 1 abnormality is acceptable)
Serum electrolytes within normal limits (CTCAE 4.0 grade 1 abnormality is acceptable)
Resolved acute effects of any prior therapy to baseline severity or Grade ?1 NCI CTCAE.
Any toxicity from prior chemotherapy has resolved or Grade 1 (NCI-CTCAE, Version 4.0)
Ongoing infection > Grade 2 NCI-CTCAE v4.0.
Subject has an ongoing toxicity ? Grade 2 (NCI CTCAE Version 4.03) attributable to prior medication to treat solid tumor (except alopecia) at screening.
Has peripheral neuropathy ? Grade 2 (NCI-CTCAE)
Active, clinically serious infections of NCI CTCAE v4.0 Grade 2 or higher within 4 weeks prior to Cycle 1, Day 1
Subject has an ongoing toxicity greater than or equal to grade 3 (NCI CTCAE version 4.03) attributable to prior NSCLC treatment at the time of screening.
Bilirubin less than or equal to 1.5 x ULN (CTCAE v4.0 grade 1)
Ongoing infection > grade 2 NCI-CTCAE v4.0
Signs of peripheral neuropathy (PN) ? NCI CTCAE Grade 2.
Signs of peripheral neuropathy (PN) ? NCI CTCAE Grade 2.
Anxiety ? CTCAE grade 3
Patients with active clinically serious infections defined as >= grade 2 according to NCI CTCAE, version 4.0
Subjects with valvular heart disease CTCAE (version 4.0) grade 2
Any peripheral neuropathy ? NCI CTCAE Grade 2.
? CTCAE Grade 3 anxiety.
Symptomatic peripheral neuropathy grade ?2 NCI CTCAE v4.0.
Diarrhoea CTCAE v4.03 Grade ? 2
Evidence of uncontrolled bradycardia or other cardiac arrhythmia defined as ?Grade 2 according to NCI CTCAE, version 4.0, or uncontrolled hypertension
History of bronchopulmonary hemorrhage NCI CTCAE >/= Grade 2 within 2 months prior to randomization
Evidence of CNS hemorrhage CTCAE ? grade 2 on baseline MRI.
NCI CTCAE (version 4.03) Grade 3 or higher toxicities due to prior therapy that have not shown improvement and are considered to interfere with current study medication
Active clinically serious infections defined as >= Grade 3 according to NCI CTCAE
CTCAE Grade 2 or 3 fatigue.
Any >=Grade 2 hypophosphatemia (per CTCAE v4.0) at the time of enrolment
Active clinically serious infection > NCI-CTCAE grade 2
? CTCAE grade 3 anxiety
Active clinically serious infection > CTCAE v 4.0 grade 2
Active clinically serious infections > Grade 2 (NCI-CTCAE Version 3.0)
follicular lymphoma (NCI CTCAE grade 1 or 2)
Ongoing infection > CTCAE grade 2
Baseline alopecia (defined CTCAE v4.0 grade > 0)
Ongoing infection > grade 2 NCI-CTCAE v4.0
AST > 2.5 x ULN (CTCAE grade 2)
Bilirubin > 1.5 x ULN (CTCAE grade 2)
Presence of neuropathy > Grade 1 per NCI CTCAE version 5.0
Current alopecia grade 2 or greater as per NCI-CTCAE v.4.0, or significant hair loss or hair breakage
Hepatic toxicity >= grade 2 (using CTCAE version 4 standard definitions)
Ongoing cardiac dysrhythmias of NCI CTCAE Grade ? 2, uncontrolled atrial fibrillation of any grade, or an average of triplicate QTc interval >470 msec.
Not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade <=1 or baseline.
Serum lipase ? 2 x ULN i.e. equivalent to ? Grade 2 NCI-CTCAE v.4.03
For Adjuvant Treatment: All AEs resulting from surgery must have resolved to NCI-CTCAE (v. 4.03) Grade ? 1