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Trial record 1 of 1 for:    PLK1 Nerviano Medical Sciences
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Study of NMS-1286937 in Adult Patients With Advanced/Metastatic Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01014429
Recruitment Status : Completed
First Posted : November 17, 2009
Last Update Posted : September 7, 2012
Information provided by (Responsible Party):
Nerviano Medical Sciences

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

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Study Type : Interventional  (Clinical Trial)
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 : November 2009
Actual Primary Completion Date : October 2011

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) and first cycle dose limiting toxicities (DLTs) [ Time Frame: Cycle 1 ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01014429

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United States, Arizona
Arizona TGen Clinical Research Services at Scottsdale Heathcare
Scottsdale, Arizona, United States, 85258
Sponsors and Collaborators
Nerviano Medical Sciences
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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
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Responsible Party: Nerviano Medical Sciences Identifier: NCT01014429    
Other Study ID Numbers: PLKA-937-001
First Posted: November 17, 2009    Key Record Dates
Last Update Posted: September 7, 2012
Last Verified: September 2012
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:
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