NL-OMON39614
Completed
Phase 2
A Phase II, multi-center, open-label, single-arm study of the efficacy and safety of oral LDE225 in patients with Hh-pathway activated relapsed medulloblastoma - LDE225 in patients with Hh+ relapsed medulloblastoma
ovartis Pharma B.V.0 sites2 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Medulloblastoma
- Sponsor
- ovartis Pharma B.V.
- Enrollment
- 2
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients aged \* 4 months
- •Patients with histologically confirmed diagnosis of MB, who have experienced relapse or progression after standard\-of\-care therapy including radiotherapy or patients aged \>4 months and \* 6 years who are RT naive.
- •Patients currently receiving steroids must have been on a stable (or decreasing) dose for at least 5 days before the brain/spine MRI obtained at screening.
- •Patients with any number of prior relapses are eligible to enroll provided they have Hh\-pathway activated tumors as assessed using the 5\-gene Hh signature assay.
- •Relapsed MB may be defined by imaging tumor biopsy, or evidence of tumor cells in the CSF.
- •At least one measurable lesion.
Exclusion Criteria
- •Prior treatment with a Smoothened inhibitor
- •Patients who have neuromuscular disorders that are associated with elevated CK
- •Patients on concomitant treatment with drugs that are recognized to cause rhabdomyolysis that cannot be discontinued at least 2 weeks before first dose of study treatment. If it is essential that the patient stays on a statin to control hyperlipidemia only pravastatin may be used with extra caution.
- •Patients receiving treatment with medications that are known to be strong inhibitors or inducers of CYP3A4/5 or are metabolized by CYP2B6 and CYP2C9, that have narrow therapeutic indices that cannot be discontinued at least 2 weeks before first dose of study treatment and for the duration of the study.
- •Patients receiving unstable or increasing doses of corticosteroids. If patients are on corticosteroids for endocrine deficiencies or tumor\-associated symptoms, dose must have been stabilized (or decreasing) for at least 5 days before the brain/spine MRI obtained at screening.
- •Patients receiving treatment with any enzyme\-inducing anticonvulsant that cannot be discontinued at least 2 weeks before first dose of study treatment, and for the duration of the study. Patients on non\-enzyme\-inducing anticonvulsants are eligible.
Outcomes
Primary Outcomes
Not specified
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