A Phase I Dose Escalation Study of NMS-1286937 Administered to Adult Patients With Advanced/Metastatic Solid Tumors
Inclusion Criteria:
- Advanced/metastatic solid tumors, for which no effective standard therapy exist
- Adult patients (age >/= 18)
- ECOG performance status (PS) 0 or 1
- Life expectancy of at least 3 months
- Adequate renal, liver function and bone marrow reserve
- Prior cancer therapy allowed, with max 4 regimens of chemotherapy. Washout: at least
4 wks (6 wks for nitrosoureas, mitomycin C and liposomal doxorubicin) and all
toxicities recovered to CTC Grade =1
- Prior radiotherapy allowed if no more than 25% of BM reserve irradiated
- Women and men of child producing potential should agree to use effective
contraception
- Capability to swallow capsules intact
Exclusion Criteria:
- Known uncontrolled/symptomatic brain metastases
- Currently active second malignancy
- Major surgery in the last 4 wks
- Any of the following in the past 6 months: myocardial infarction, unstable angina,
coronary/peripheral artery bypass graft, symptomatic congestive heart failure,
cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein
thrombosis
- Pregnancy or breast-feeding women
- Known active infections
- History of drug allergic reactions
- Gastrointestinal disease or other malabsorption syndromes that would impact on drug
absorption.
- Documented gastrointestinal ulcer
- Other severe concurrent acute or chronic medical or psychiatric condition that could
compromise protocol objectives