- Documented histological or cytological diagnosis confirming the presence of malignant
solid tumor
- Tumor progression after conventional therapy for cancer or a malignant solid tumor for
which no conventional therapy exists
- Subjects enrolled in the MTD confirmation cohort should have a documented histologic
and/or cytologic diagnosis of metastatic breast cancer or non-small cell lung cancer
(NSCLC) and should not have received more than 2 prior chemotherapy regimens for
metastatic disease (adjuvant and neoadjuvant chemotherapy will not be included in the
maximum of 2 prior regimens described above)
- Subjects with symptomatic or clinically active central nervous system (CNS)
metastases. Subjects who have had prior treatment with radiotherapy or surgical
resection for CNS metastases will be permitted if CNS metastases have remained stable
and have not required any treatment for at least 3 months prior to first dose of test
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- History of any other primary malignancy with less than 5 years documentation of a
disease-free state (Subjects with a history of basal cell or squamous cell carcinomas
of the skin or cervical carcinoma in situ, which have been successfully treated, are
not excluded)
- Recent major surgery (within 14 days before the first dose) or chemotherapy within 28
days before the first dose of MST-997 (42 days if the previous chemotherapy included
nitrosoureas or mitomycin C)