Dose Finding and Safety of Oral LDE225 in Patients With Advanced Solid Tumors

Novartis

Status and phase: Completed; Phase 1

Conditions: Medulloblastoma; Advanced Solid Tumor Cancers; Basal Cell Carcinoma

Treatments: Drug: LDE225

Study type: Interventional

Funder types: Industry

Identifiers

NCT00880308

2008-005603-26 (EudraCT Number)

CLDE225X2101

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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103 participants in 1 patient group

LDE225

Experimental group

Treatment:

Drug: LDE225