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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01106508
First received: April 16, 2010
Last updated: May 27, 2014
Last verified: May 2014
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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:

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

Secondary Outcome Measures:
  • To characterize the safety and tolerability of LEQ506 treatment [ Time Frame: 21 day cycles ] [ Designated as safety issue: Yes ]
  • To characterize the pharmacokinetics of LEQ506 [ Time Frame: 21 day cycles ] [ Designated as safety issue: No ]
  • To characterize the pharmacodynamic effects of LEQ506 in skin and tumor samples [ Time Frame: 21 day cycles ] [ Designated as safety issue: No ]
  • Tumor response [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01106508     History of Changes
Other Study ID Numbers: CLEQ506X2101, 2009-017969-30
Study First Received: April 16, 2010
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Netherlands: Medicines Evaluation Board (MEB)
Switzerland: Swissmedic

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

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

ClinicalTrials.gov processed this record on September 22, 2014