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Completed

NCT Number: NCT01014429

Study of NMS-1286937 in 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.

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Key information

Conditions

Advanced or Metastatic Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arizona TGen Clinical Research Services at Scottsdale Heathcare

Scottsdale, Arizona, 85258, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NMS-1286937

Drug

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

Primary outcomes

  1. Maximum tolerated dose (MTD) and first cycle dose limiting toxicities (DLTs)

    Time frame: Cycle 1

Secondary outcomes

  1. 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

  2. Evaluation of pharmacodynamics: biomarkers modulation in skin and/or tumor samples of consenting patients

    Time frame: Cycles 1 and 2

Sponsors and collaborators

Lead sponsor

Nerviano Medical Sciences

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
First posted
Nov 17, 2009
Registry last updated
Sep 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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