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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01106508

Enrollment

Registered

2010-04-20

Start date

2010-10-31

Completion date

2015-06-30

Last updated

2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Advanced solid tumors, recurrent or refractory medulloblastoma, locally advanced or metastatic basal cell carcinoma, hedgehog pathway inhibitor

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.

Interventions

DRUGLEQ506

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Netherlands, Switzerland, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026