Study of NMS-1286937 in Adult Patients With Advanced/Metastatic Solid Tumors

A Phase I Dose Escalation Study of NMS-1286937 Administered to Adult Patients With Advanced/Metastatic Solid Tumors

The purpose of this study is to evaluate the safety and tolerability of NMS-1286937, a polo-like-kinase 1 inhibitor, in patients with advanced metastatic solid tumor.

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