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

Phase 1

Completed

• Conditions: Locally Advanced or Metastatic Basal Cell Carcinoma; Recurrent or Refractory Medulloblastoma; Advanced Solid Tumors
• Interventions: Drug: LEQ506

• Registration Number: NCT01106508
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-16
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-20
• Study Start: 2010-10
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-01
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LEQ506	LEQ506	-

Primary Outcome Measures

Name	Time	Method
To determine the maximum tolerated dose and characterize the dose limiting toxicities of LEQ506	21 day cycles

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

University of California at Los Angeles UCLA LeConte Location; 🇺🇸 Los Angeles, California, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Novartis Investigative Site; 🇬🇧 Oxford, United Kingdom