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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 25, 2014