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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
  Purpose

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 Intervention Phase
Advanced or Metastatic Solid Tumors
 Drug: NMS-1286937
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Nerviano Medical Sciences:

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

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) [ 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 ]

Enrollment: 21
Study Start Date: November 2009
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: NMS-1286937
Single Arm, dose escalation study. No. of cycles: until progression or unacceptable toxicity develops.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014429

Locations
United States, Arizona
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
  More Information

No publications provided

Responsible Party: Nerviano Medical Sciences
ClinicalTrials.gov Identifier: NCT01014429     History of Changes
Other Study ID Numbers: PLKA-937-001
Study First Received: November 16, 2009
Last Updated: September 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Nerviano Medical Sciences:
Phase I dose escalation study
Advanced or metastatic solid tumors
PLK 1 inhibitor
Adult patients

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013