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

September 6, 2012 updated by: Nerviano Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Arizona TGen Clinical Research Services at Scottsdale Heathcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum tolerated dose (MTD) and first cycle dose limiting toxicities (DLTs)
Time Frame: Cycle 1
Cycle 1

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Cycles 1 and 2
Evaluation of pharmacodynamics: biomarkers modulation in skin and/or tumor samples of consenting patients
Time Frame: Cycles 1 and 2
Cycles 1 and 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

November 16, 2009

First Submitted That Met QC Criteria

November 16, 2009

First Posted (ESTIMATE)

November 17, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 7, 2012

Last Update Submitted That Met QC Criteria

September 6, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLKA-937-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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