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A Dose Finding and Safety Study of Oral LEQ506 in Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01106508
First Posted: April 20, 2010
Last Update Posted: January 12, 2016
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This first-in-human dose-escalation study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LEQ506 given orally on a daily dosing schedule in patients with advanced solid tumors.

Condition Intervention Phase
Advanced Solid Tumors Recurrent or Refractory Medulloblastoma Locally Advanced or Metastatic Basal Cell Carcinoma Drug: LEQ506 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Multi-center, Open Label, Dose Escalation Study of LEQ506, an Oral Smoothened Inhibitor, in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • To determine the maximum tolerated dose and characterize the dose limiting toxicities of LEQ506 [ Time Frame: 21 day cycles ]

Secondary Outcome Measures:
  • To characterize the safety and tolerability of LEQ506 treatment [ Time Frame: 21 day cycles ]
  • To characterize the pharmacokinetics of LEQ506 [ Time Frame: 21 day cycles ]
  • To characterize the pharmacodynamic effects of LEQ506 in skin and tumor samples [ Time Frame: 21 day cycles ]
  • Tumor response [ Time Frame: every 6 weeks ]

Enrollment: 57
Study Start Date: October 2010
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LEQ506 Drug: LEQ506

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Confirmed diagnosis of advanced solid tumor, recurrent or refractory medulloblastoma or locally advanced or metastatic basal cell carcinoma)
  • Protocol defined laboratory parameters
  • Performance status ≤ 2
  • Patients must have fully recovered from the prior effects of major surgery and from any acute toxicities of prior chemotherapy/radiotherapy

Exclusion Criteria:

  • History of central nervous system tumors of symptomatic brain metastases (excludes medulloblastoma patients)
  • Impairment of gastrointestinal function or unresolved nausea, vomiting or diarrhea
  • Impairment of cardiac function or significant cardiac disease
  • Pregnant or lactating women
  • Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01106508


Locations
United States, California
University of California at Los Angeles UCLA LeConte Location
Los Angeles, California, United States, 90095
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Netherlands
Novartis Investigative Site
Utrecht, Netherlands, 3584CX
Switzerland
Novartis Investigative Site
Zürich, Switzerland, 8091
United Kingdom
Novartis Investigative Site
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01106508     History of Changes
Other Study ID Numbers: CLEQ506X2101
2009-017969-30 ( EudraCT Number )
First Submitted: April 16, 2010
First Posted: April 20, 2010
Last Update Posted: January 12, 2016
Last Verified: January 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Advanced solid tumors
recurrent or refractory medulloblastoma
locally advanced or metastatic basal cell carcinoma
hedgehog pathway inhibitor

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Medulloblastoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroectodermal Tumors, Primitive
Neoplasms, Nerve Tissue