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Completed

NCT Number: NCT01106508

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

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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Key information

Conditions

Advanced Solid Tumors Carcinoma Carcinoma, Basal Cell Disease Attributes Glioma Locally Advanced or Metastatic Basal Cell Carcinoma Medulloblastoma Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Recurrent or Refractory Medulloblastoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Utrecht, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LEQ506

Drug

Primary outcomes

  1. To determine the maximum tolerated dose and characterize the dose limiting toxicities of LEQ506

    Time frame: 21 day cycles

Secondary outcomes

  1. To characterize the safety and tolerability of LEQ506 treatment

    Time frame: 21 day cycles

  2. To characterize the pharmacokinetics of LEQ506

    Time frame: 21 day cycles

  3. To characterize the pharmacodynamic effects of LEQ506 in skin and tumor samples

    Time frame: 21 day cycles

  4. Tumor response

    Time frame: every 6 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Apr 20, 2010
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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