EUCTR2012-003066-40-NL
Active, not recruiting
Phase 1
A Phase II, multi-center, open-label, single-arm study of the efficacy and safety of oral LDE225 versus temozolomide in patients with Hh-pathway activated relapsed medulloblastoma - CLIMB
ConditionsRelapsed medulloblastoma characterised by Hedgehog (Hh)-pathway activationMedDRA version: 19.0Level: PTClassification code 10066594Term: Medulloblastoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Relapsed medulloblastoma characterised by Hedgehog (Hh)-pathway activation
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 9 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
- •\- 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
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.
Outcomes
Primary Outcomes
Not specified
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