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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01106508

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

11.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

57 participants

Allocation:

N/A

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

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LEQ506	Drug: LEQ506

Arm

Intervention/Treatment

Experimental: LEQ506

Drug: LEQ506

Outcome Measures

Primary Outcome Measures

To determine the maximum tolerated dose and characterize the dose limiting toxicities of LEQ506 [21 day cycles]

Secondary Outcome Measures

To characterize the safety and tolerability of LEQ506 treatment [21 day cycles]
To characterize the pharmacokinetics of LEQ506 [21 day cycles]
To characterize the pharmacodynamic effects of LEQ506 in skin and tumor samples [21 day cycles]
Tumor response [every 6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of California at Los Angeles UCLA LeConte Location	Los Angeles	California	United States	90095
2	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10021
3	Novartis Investigative Site	Utrecht		Netherlands	3584CX
4	Novartis Investigative Site	Zürich		Switzerland	8091
5	Novartis Investigative Site	Oxford		United Kingdom	OX3 7LJ