| Inclusion Criteria: | 1) Criterion modified per amendment: 15 years of age or older at the time of screening.
2) Criterion modified per amendment: Unresectable advanced or metastatic histologically proven non L-type STS. - The site must provide documentation to the sponsor of the subject's non L-type STS diagnosis prior to their enrollment.
3) Subjects must have relapsed or had progressive disease following standard of care treatment with chemotherapy prior to enrollment or intolerant to prior standard of care treatment with chemotherapy due to safety issues.
4) Recovery from toxic effects of prior therapies to Grade 1 or better according to National Cancer Institute Common Terminology Criteria of Adverse Events (NCI-CTCAE), Version 4.
5) Hematologic test results: Hemoglobin greater than or equal to 8 g/dL, absolute neutrophil count (ANC) greater than or equal to 1,500/microliter, platelet count greater than or equal to 100,000/microliter.
6) Criterion modified per amendment. Clinical chemistry test results: -Serum creatinine less than or equal to 1.5 x the upper limit of normal (ULN), creatine phosphokinase (CPK) less than or equal to 2.5 x ULN.
7) Hepatic function test results: Total bilirubin less than or equal to ULN, if increased then measure indirectly to rule out Gilbert's syndrome. If direct bilirubin is within normal limits, subject may be considered eligible. ALP less than or equal to 2.5 x ULN; or if greater than 2.5 x ULN, then an ALP liver fraction or 5' nucleotidase must be obtained and less than or equal to ULN. AST and ALT must be less than or equal to 2.5 x ULN.
8) Criterion modified per amendment: Female subjects must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent (at the discretion of the investigator), or if sexually active, be practicing an effective method of birth control (eg, prescription hormonal contraceptive, intrauterine device, double-barrier method [eg, condoms and occlusive cap (diaphragm or cervical/vault caps)] with spermicidal foam, cream, gel, film, suppository),
9) (Inclusion #8 Continued) before entry, and must agree to continue to use the same method of contraception throughout the study and for 3 months thereafter. Male subjects must agree to use an adequate contraception method as deemed appropriate by the investigator (eg, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm for a minimum of 5 months after treatment discontinuation.
10) Criterion modified for amendment: Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Assent is also required for subjects who are 15 years of age and up to the age of legal consent in the jurisdiction in which the study is to take place and who are capable of understanding the nature of the study. |