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

Sponsor

Nerviano Medical Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT01014429

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced or Metastatic Solid Tumors	Drug: NMS-1286937	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2009

Actual Primary Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: NMS-1286937 Single Arm, dose escalation study. No. of cycles: until progression or unacceptable toxicity develops.

Arm

Intervention/Treatment

Experimental: 1

Drug: NMS-1286937

Single Arm, dose escalation study. No. of cycles: until progression or unacceptable toxicity develops.

Outcome Measures

Primary Outcome Measures

Maximum tolerated dose (MTD) and first cycle dose limiting toxicities (DLTs) [Cycle 1]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona TGen Clinical Research Services at Scottsdale Heathcare	Scottsdale	Arizona	United States	85258

Sponsors and Collaborators

Nerviano Medical Sciences

Investigators

Study Director: Mariangela Mariani, Biol Sci D, Nerviano Medical Sciences
Study Director: Maria Adele Pacciarini, Biol Sci D, Nerviano Medical Sciences
Principal Investigator: Glen J Weiss, MD, Arizona TGen Clinical Reserch Services at Scottsdale Healthcare