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Clinical Trials/EUCTR2012-003066-40-FR
EUCTR2012-003066-40-FRActive, not recruitingPhase 1

A Phase III, multi-center, open-label, randomized, controlled study of the efficacy and safety of oral LDE225 versus temozolomide in patients with Hh-pathway activated relapsed medulloblastoma

ovartis Pharma Services AG0 sites109 target enrollmentStarted: May 22, 2013Last updated:
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Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
109
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •- Patients aged >= 4 months
  • •- Patients with histologically confirmed diagnosis of MB, who have experienced relapse or progression
  • •- Only patients with a test result, using the 5-gene Hh signature assay, indicating Hh-pathway activated MB are eligible for this study.
  • •- At least one measurable lesion
  • •- Adequate renal function
  • •- Adequate liver function
  • •- Adequate bone marrow function
  • •- Serum CK <= 1.5 ULN
  • •Other protocol defined inclusion criteria may apply.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 48
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 59
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

  • •- Prior treatment with a Smoothened inhibitor
  • •- Systemic anticancer treatment within 2 weeks before first dose of study treatment
  • •- Focal radiation therapy within 4 weeks before first dose of study treatment, or full spinal radiotherapy within 3 months before first dose of study treatment.
  • •- Patients who have neuromuscular disorders that are associated with elevated CK
  • •- Any concurrent severe and/or uncontrolled medical conditions that in the investigator’s opinion could put the patient at greater risk for treatment-related toxicities or confound the interpretation of clinical outcomes.
  • •- Impaired cardiac function
  • •- Clinically significant heart disease
  • •- Known diagnosis of human immunodeficiency virus (HIV), Hepatitis B or C
  • •- Impairment of GI function or GI disease
  • •- Major surgery, serious illness, or traumatic injury within 2 weeks of first dose of study treatment.
  • •- Unresolved toxicity greater than CTCAE grade 1 from previous anticancer therapy
  • •- Patients anticipated to require major surgery within the first 8 weeks of treatment
  • •- Patients who require a nasogastric tube for drug administration
  • •- Patients on concomitant treatment with drugs that are recognized to cause rhabdomyolysis
  • •- Patients receiving treatment with medications that are known to be strong inhibitors or inducers of CYP3A4/5 or are metabolized by CYP2B6 and CYP2C9.
  • •- Patients receiving unstable or increasing doses of corticosteroids
  • •- 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
  • •- Investigational agents within 4 weeks or = 5 x t1/2 (whichever is longer) before first dose of study treatment.
  • •- Pregnant females.
  • •- Patients who are not willing to apply highly effective contraception.
  • •- Patients who are planning on embarking on a new strenuous exercise regimen after first dose of study treatment.
  • •Other protocol defined exclusion criteria may apply.

Investigators

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