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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nerviano Medical Sciences

Criteria

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
• 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