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Clinical Trials/EUCTR2012-003066-40-SE
EUCTR2012-003066-40-SE
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

ovartis Pharma Services AG0 sites20 target enrollmentNovember 16, 2012
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ConditionsRelapsed medulloblastoma characterised by Hedgehog (Hh)-pathway activationMedDRA version: 19.1Level: 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
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 16, 2012
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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

Similar Trials

Active, not recruiting
Phase 1
A clinical study to test the efficacy and safety of LDE225 compared to temozolomide in patients with a specific type of brain tumourRelapsed medulloblastoma characterised by Hedgehog (Hh)-pathway activationMedDRA version: 17.0Level: PTClassification code 10066594Term: Medulloblastoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
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A clinical study to test the efficacy and safety of LDE225 in patients with a specific type of brain tumourRelapsed 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]
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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 medulloblastomaMedulloblastomamalignant brain tumor10029211
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