A Phase Ib/II study of LGX818 in combination with MEK162 in adult patients with BRAF dependent advanced solid tumors

• Conditions: Patients with solid tumors harboring a BRAF V600 mutation.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-005875-17-FR
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-16
• Last Update Posted: 21 September 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

• Age = 18 years for both phases and arms
• Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB to IV per American Joint Committee on Cancer [AJCC]), or confirmed diagnosis of non-resectable advanced metastatic colorectal cancer (mCRC), or any other indication upon agreement with the Sponsor, whose disease has progressed despite previous antineoplastic therapy or for whom no further effective standard therapy is available.
• Written documentation of BRAF V600E mutation, or any other BRAF V600 mutation.
• Evidence of measurable disease as determined by RECIST v1.1.
• World Health Organization (WHO) Performance Status = 2.
• Negative serum pregnancy test within 72 hours prior to the first study
dose in all women of childbearing potential.
• for phase II : availability of a tumor biopsy
Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 114
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

Exclusion Criteria

• Progressive disease following prior treatment with RAF-inhibitors in combination with MEK-inhibitors.
• Symptomatic or untreated leptomeningeal disease.
• Symptomatic brain metastases. Patients are not permitted to receive enzyme inducing anti-epileptic drugs.
• Known acute or chronic pancreatitis.
• History or current evidence of retinal disease, retinal vein occlusion or ophthalmopathy.
• Clinically significant cardiac disease.
• Patients with abnormal laboratory values at Screening/baseline.
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LGX818/MEK162
• Previous or concurrent malignancy.
• Pregnant or nursing (lactating) women.
Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified