Dose Finding and Safety of Oral LDE225 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:
NCT00880308
First received: April 9, 2009
Last updated: March 7, 2013
Last verified: March 2013
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Purpose
This first-in-human dose-escalation study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LDE225 given orally on a daily dosing schedule in patients with advanced solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumor Cancers Medulloblastoma Basal Cell Carcinoma |
Drug: LDE225 |
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, Multicenter, Open-label, Dose-escalation Study of Oral LDE225 in Patients With Advanced Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- determine maximum tolerated dose of single agent LDE225 [ Time Frame: 28 day cycles ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- characterize safety and tolerability [ Time Frame: 28 day cycles ] [ Designated as safety issue: Yes ]
- characterize pharmacokinetics (PK) of single and repeated doses of LDE225 [ Time Frame: 28 day cycles ] [ Designated as safety issue: Yes ]
- assess preliminary anti-tumor activity [ Time Frame: every other 28-day cycle ] [ Designated as safety issue: No ]
| Enrollment: | 122 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | December 2013 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: LDE225 | Drug: LDE225 |
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 (including •medulloblastoma and basal cell carcinoma)
- blood work criteria
Exclusion Criteria:
- patients with history of brain tumor (except recurrent medulloblastoma) or brain metastases
- positive HIV, hepatitis B or C
- impaired intestinal function
- impaired heart function
- pregnant or breast-feeding women
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880308
Locations
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center SC | |
| Pittsburgh, Pennsylvania, United States | |
| United States, Texas | |
| Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5) | |
| San Antonio, Texas, United States, 78229 | |
| Spain | |
| Novartis Investigative Site | |
| Barcelona, Cataluna, Spain, 08035 | |
| Switzerland | |
| Novartis Investigative Site | |
| Zürich, Switzerland, 8091 | |
| United Kingdom | |
| Novartis Investigative Site | |
| Leicester, United Kingdom, LE1 5WW | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00880308 History of Changes |
| Other Study ID Numbers: | CLDE225X2101, 2008-005603-26 |
| Study First Received: | April 9, 2009 |
| Last Updated: | March 7, 2013 |
| Health Authority: | United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency Spain: Spanish Agency of Medicines Switzerland: Swissmedic |
Keywords provided by Novartis:
|
Advanced tumors hedgehog smoothened 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 June 18, 2013