A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma (BOLT)

Novartis

Status and phase: Completed; Phase 2

Conditions: Basal Cell Carcinoma

Treatments: Drug: LDE225

Study type: Interventional

Funder types: Industry

Identifiers

NCT01327053

2010-022629-14 (EudraCT Number)

CLDE225A2201

Details and patient eligibility

About

This study assessed the efficacy and safety of oral treatment with two dose levels of LDE225 in patients with locally advanced or metastatic BCC.

Enrollment: 230 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with locally advanced BCC and metastatic BCC
• Patients with adequate bone marrow, liver, and renal function

Exclusion criteria

• Patients who had had major surgery within 4 weeks of initiation of study medication
• Patients unable to take oral drugs or with lack of physical integrity of the upper gastrointestinal tract, or known malabsorption syndromes.
• Patients with concurrent medical conditions that may interfere or potentially affect the interpretation of the study.
• Patients with neuromuscular disorders or are on concurrent treatment with drugs that may cause muscle damage.
• Patients who were on concurrent therapy with other anti-neoplastic agents.
• Patients who had taken part in an experimental drug within 4 weeks of initiation of study medication.
• Pregnant or nursing (lactating) women
• Women of child bearing potential unwilling to use 2 forms of highly effective contraception throughout the study and for 3 months after the last treatment
• Fertile males not willing to use condoms throughout the study and for 3 months after the last treatment.
• Patients who were unwilling or unable to comply with the protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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230 participants in 2 patient groups

LDE225 200 mg

Experimental group

Description:

The study was double blinded and enrolled at least 50 evaluable patients in the 200 mg LDE225 arm. The efficacy and safety of LDE225 was analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.

Treatment:

Drug: LDE225

LDE225 800 mg

Experimental group

Description:

The study was double blinded and enrolled at least 100 evaluable patients in the 800 mg LDE225 arm. The efficacy and safety of LDE225 was analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.

Treatment:

Drug: LDE225