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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

November 16, 2009
September 6, 2012
November 2009
October 2011   (final data collection date for primary outcome measure)
Maximum tolerated dose (MTD) and first cycle dose limiting toxicities (DLTs) [ Time Frame: Cycle 1 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01014429 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of NMS-1286937 in Adult Patients With Advanced/Metastatic Solid Tumors
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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced or Metastatic Solid Tumors
Drug: NMS-1286937
Single Arm, dose escalation study. No. of cycles: until progression or unacceptable toxicity develops.
Experimental: 1
Intervention: Drug: NMS-1286937
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
Not Provided
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01014429
PLKA-937-001
No
Nerviano Medical Sciences
Nerviano Medical Sciences
Not Provided
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
Nerviano Medical Sciences
September 2012

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