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

Nerviano Medical Sciences

Status and phase

Completed

Phase 1

Conditions

Advanced or Metastatic Solid Tumors

Treatments

Drug: NMS-1286937

Study type

Interventional

Funder types

Industry

Identifiers

NCT01014429

PLKA-937-001

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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