A Phase I Clinical Study With Investigational Compound LTT462 in Adult Patients With Specific Advanced Cancers.

• Status: Terminated
• Trial end date: 2018-11-21
• Target enrollment: 0
• Participant gender: All

Summary

A phase I study of LTT462 in patients with advanced solid tumors that harbor MAPK pathway alterations.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Patient (male or female) ≥12 years of age

• ECOG (Eastern Cooperative Oncology Group) performance status ≤1

• Must have progressed following standard therapy, or for whom, in the opinion of the Investigator, no effective standard therapy exists, is tolerated or appropriate.

• Patients must be willing and able to undergo study required biopsies.

• Presence of at least one measurable lesion according to RECIST v1.1.

• Documented MAPK pathway alteration

Exclusion Criteria:

• Prior treatment with ERK inhibitors.

• History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.

• Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.

• Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study.

• Patients with malignant disease other than that being treated in the study.

• Clinically significant cardiac disease.

Other protocol-defined exclusion criteria may apply.