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

Novartis

Status and phase: Completed; Phase 1

Conditions: Recurrent or Refractory Medulloblastoma; Advanced Solid Tumors; Locally Advanced or Metastatic Basal Cell Carcinoma

Treatments: Drug: LEQ506

Study type: Interventional

Funder types: Industry

Identifiers

NCT01106508

CLEQ506X2101

2009-017969-30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

LEQ506

Experimental group

Treatment:

Drug: LEQ506