A Dose Finding and Safety Study of Oral LEQ506 in Patients With Advanced Solid Tumors
Completed · Phase 1
Conditions studied: Advanced Solid Tumors, Recurrent or Refractory Medulloblastoma, Locally Advanced or Metastatic Basal Cell Carcinoma
In brief
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.
Key facts
- Study ID
- NCT01106508
- Run by
- Novartis Pharmaceuticals
- People needed
- 57
- Starts
- 2010-10-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2020-12-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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 — Utrecht, Netherlands
- Novartis Investigative Site — Zurich, Switzerland
- Novartis Investigative Site — Oxford, United Kingdom
Full record on ClinicalTrials.gov
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