A Multicenter Phase I Clinical Study of a New Compound P1446A-05 in Patients With Advanced Refractory Malignancies

Exclusion Criteria

• •autologous or allogeneic bone marrow transplant within 6 months of day 1 of study drug administration
• •Known brain metastases at the time of screening
• •Any other investigational drug within 1 month prior to day 1 of study drug administration or not recovered (to ≤grade 1) from adverse effects of the investigational agent received prior to this period.
• •History of allergic reactions attributed to compounds of similar chemical structure to P1446A-05.
• •On immunosuppressive therapy.
• •History of unstable angina or myocardial infarction or stroke within 6 months prior to Day 1 of study drug administration.
• •Uncontrolled inter-current illness including, but not limited to active infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• •Known to be suffering from infection with HIV, Tuberculosis, Hepatitis C or Hepatitis B.
• •Pregnant or lactating women
• •Women of childbearing potential \[defined as a sexually mature woman who has not undergone hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e. who has had menses any time in the preceding 24 consecutive months)\] and men, not agreeing to use adequate contraception (two methods of contraception, including at least one barrier method, - i.e. : hormonal and a barrier method of birth control or abstinence) prior to study entry (after signing the informed consent document), during the duration of study participation and for at least 4 weeks after withdrawal from the study drug, unless they are surgically sterilised.
• •Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at an unacceptable risk or deems the subject not suitable for participation in the study.