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

Advanced Solid Tumors Clinical Trial

Official title:

A Phase I, Multi-center, Open Label, Dose Escalation Study of LEQ506, an Oral Smoothened Inhibitor, in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01106508
• Other study ID #: CLEQ506X2101
• Secondary ID: 2009-017969-30
• Status: Completed
• Phase: Phase 1
• Start date: October 2010
• Est. completion date: June 2015

Study information

• Verified date: January 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Carcinoma, Basal Cell
• Locally Advanced or Metastatic Basal Cell Carcinoma
• Medulloblastoma
• Recurrent or Refractory Medulloblastoma

Intervention

Drug:
• LEQ506

Locations

Country	Name	City	State
Netherlands	Novartis Investigative Site	Utrecht
Switzerland	Novartis Investigative Site	Zürich
United Kingdom	Novartis Investigative Site	Oxford
United States	University of California at Los Angeles UCLA LeConte Location	Los Angeles	California
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Netherlands,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the maximum tolerated dose and characterize the dose limiting toxicities of LEQ506		21 day cycles
Secondary	To characterize the safety and tolerability of LEQ506 treatment		21 day cycles
Secondary	To characterize the pharmacokinetics of LEQ506		21 day cycles
Secondary	To characterize the pharmacodynamic effects of LEQ506 in skin and tumor samples		21 day cycles
Secondary	Tumor response		every 6 weeks

External Links

•   Results for CLEQ506X2101 on the Novartis Clinical Trials website