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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LEQ506

Group Type EXPERIMENTAL

LEQ506

Intervention Type DRUG

Interventions

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LEQ506

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No