Back to resultsA Dose Finding and Safety Study of Oral LEQ506 in Patients With Advanced Solid Tumors
Primary Purpose
Advanced Solid Tumors, Recurrent or Refractory Medulloblastoma, Locally Advanced or Metastatic Basal Cell Carcinoma
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LEQ506
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Solid Tumors focused on measuring Advanced solid tumors, recurrent or refractory medulloblastoma, locally advanced or metastatic basal cell carcinoma, hedgehog pathway inhibitor
Eligibility 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
Sites / Locations
- University of California at Los Angeles UCLA LeConte Location
- Memorial Sloan Kettering Cancer Center
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LEQ506
Arm Description
Outcomes
Primary Outcome Measures
To determine the maximum tolerated dose and characterize the dose limiting toxicities of LEQ506
Secondary Outcome Measures
To characterize the safety and tolerability of LEQ506 treatment
To characterize the pharmacokinetics of LEQ506
To characterize the pharmacodynamic effects of LEQ506 in skin and tumor samples
Tumor response
Full Information
NCT ID
NCT01106508
First Posted
April 16, 2010
Last Updated
December 16, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01106508
Brief Title
A Dose Finding and Safety Study of Oral LEQ506 in Patients With Advanced Solid Tumors
Official Title
A Phase I, Multi-center, Open Label, Dose Escalation Study of LEQ506, an Oral Smoothened Inhibitor, in Patients With Advanced Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumors, Recurrent or Refractory Medulloblastoma, Locally Advanced or Metastatic Basal Cell Carcinoma
Keywords
Advanced solid tumors, recurrent or refractory medulloblastoma, locally advanced or metastatic basal cell carcinoma, hedgehog pathway inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LEQ506
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
LEQ506
Primary Outcome Measure Information:
Title
To determine the maximum tolerated dose and characterize the dose limiting toxicities of LEQ506
Time Frame
21 day cycles
Secondary Outcome Measure Information:
Title
To characterize the safety and tolerability of LEQ506 treatment
Time Frame
21 day cycles
Title
To characterize the pharmacokinetics of LEQ506
Time Frame
21 day cycles
Title
To characterize the pharmacodynamic effects of LEQ506 in skin and tumor samples
Time Frame
21 day cycles
Title
Tumor response
Time Frame
every 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of California at Los Angeles UCLA LeConte Location
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Novartis Investigative Site
City
Utrecht
ZIP/Postal Code
3584CX
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=14808
Description
Results for CLEQ506X2101 on the Novartis Clinical Trials website
Learn more about this trial
A Dose Finding and Safety Study of Oral LEQ506 in Patients With Advanced Solid Tumors
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