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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Nerviano Medical Sciences

ClinicalTrials.gov Identifier:

NCT01014429

First received: November 16, 2009

Last updated: September 6, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 16, 2009

Last Updated Date

September 6, 2012

Start Date ^ICMJE

November 2009

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Maximum tolerated dose (MTD) and first cycle dose limiting toxicities (DLTs) [ Time Frame: Cycle 1 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01014429 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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) [ Time Frame: Cycles 1 and 2 ] [ Designated as safety issue: No ]
Evaluation of pharmacodynamics: biomarkers modulation in skin and/or tumor samples of consenting patients [ Time Frame: Cycles 1 and 2 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Advanced or Metastatic Solid Tumors

Intervention ^ICMJE

Drug: NMS-1286937

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

Study Arm (s)

Experimental: 1

Intervention: Drug: NMS-1286937

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01014429

Other Study ID Numbers ^ICMJE

PLKA-937-001

Has Data Monitoring Committee

Responsible Party

Nerviano Medical Sciences

Study Sponsor ^ICMJE

Nerviano Medical Sciences

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Nerviano Medical Sciences

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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