Tolerability of Utidelone Capsule in Patients With Advanced Solid Tumors

Inclusion Criteria

• •1. Willing and able to sign a written informed consent;
• •2. Patients with histologic or pathologic documentation of incurable, locally advanced, or metastatic solid tumors for which standard therapies are not available, no longer effective, and not tolerated, and for those patients who have declined the standard therapies;
• •3. Male or female subjects aged ≥18, with ECOG performance status scored 0-1;
• •4. Expected survival time ≥ 12 weeks;
• •5. Adequate organ and marrow function as defined below:
• •1. neutrophil count (ANC) ≥ 1.5 × 109/L
• •2. platelet count (PLT) ≥ 100 × 109/L
• •3. hemoglobin ≥ 9 g/dL
• •4. total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN)
• •5. alanine transaminase (ALT) ≤ 2.5 × ULN
• •6. aspartate transaminase (AST) ≤ 2.5 × ULN
• •7. Creatinine clearance ≥ 60 mL/min
• •6. Female patients of childbearing potential must have negative serum or urine pregnancy test at screening;
• •7. Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives \[any hormonal method in conjunction with a secondary method\], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile \[at least 6 months prior to Study drug administration\] sexual partner) for at least 4 weeks prior to study drug administration, during study and up to 30 days or till next chemotherapy cycle. Cessation of birth control after this point should be discussed with a responsible physician. Investigator will discuss with patient on the above points and the patient agreement will be documented in the source document. The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol. In case of Male patients: Either patient partners or patients themselves must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 30 days or till next chemotherapy cycle.