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

Phase 1

Completed

• Conditions: Advanced or Metastatic Solid Tumors
• Interventions: Drug: NMS-1286937

• Registration Number: NCT01014429
• Lead Sponsor: Nerviano Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-16
• Study First Submitted QC: 2009-11-16
• Study First Posted: 2009-11-17
• Primary Completion: 2011-10
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-06
• Last Update Posted: 2012-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	NMS-1286937	-

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD) and first cycle dose limiting toxicities (DLTs)	Cycle 1

Secondary Outcome Measures

Name	Time	Method
Evaluation of pharmacokinetics: plasma concentration at different times after dosing, area under the curve (AUC), maximum plasma concentration (Cmax), clearance (CL), volume of distribution, half-life (t½)	Cycles 1 and 2
Evaluation of pharmacodynamics: biomarkers modulation in skin and/or tumor samples of consenting patients	Cycles 1 and 2

Trial Locations

Locations (1)

Arizona TGen Clinical Research Services at Scottsdale Heathcare; 🇺🇸 Scottsdale, Arizona, United States