A Dose Finding and Safety Study of Oral LEQ506 in Patients With Advanced Solid Tumors
This study is ongoing, but not recruiting participants.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01106508
First received: April 16, 2010
Last updated: May 10, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors Recurrent or Refractory Medulloblastoma Locally Advanced or Metastatic Basal Cell Carcinoma |
Drug: LEQ506 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I, Multi-center, Open Label, Dose Escalation Study of LEQ506, an Oral Smoothened Inhibitor, in Patients With Advanced Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- To determine the maximum tolerated dose and characterize the dose limiting toxicities of LEQ506 [ Time Frame: 21 day cycles ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To characterize the safety and tolerability of LEQ506 treatment [ Time Frame: 21 day cycles ] [ Designated as safety issue: Yes ]
- To characterize the pharmacokinetics of LEQ506 [ Time Frame: 21 day cycles ] [ Designated as safety issue: No ]
- To characterize the pharmacodynamic effects of LEQ506 in skin and tumor samples [ Time Frame: 21 day cycles ] [ Designated as safety issue: No ]
- Tumor response [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 55 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: LEQ506 | Drug: LEQ506 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01106508
Locations
| United States, California | |
| University of California at Los Angeles UCLA LeConte Location | |
| Los Angeles, California, United States, 90095 | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Netherlands | |
| Novartis Investigative Site | |
| Utrecht, Netherlands, 3584CX | |
| Switzerland | |
| Novartis Investigative Site | |
| Zürich, Switzerland, 8091 | |
| United Kingdom | |
| Novartis Investigative Site | |
| Oxford, United Kingdom, OX3 7LJ | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01106508 History of Changes |
| Other Study ID Numbers: | CLEQ506X2101, 2009-017969-30 |
| Study First Received: | April 16, 2010 |
| Last Updated: | May 10, 2013 |
| Health Authority: | United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency Netherlands: Medicines Evaluation Board (MEB) Switzerland: Swissmedic |
Keywords provided by Novartis:
|
Advanced solid tumors recurrent or refractory medulloblastoma locally advanced or metastatic basal cell carcinoma hedgehog pathway inhibitor |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Basal Cell Medulloblastoma Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Basal Cell |
Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroectodermal Tumors, Primitive Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 21, 2013