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

Novartis

Status and phase: Terminated; Phase 1

Conditions: Other Solid Tumors; Non-Small-Cell Lung Carcinoma; Ovarian Neoplasms; Melanoma

Treatments: Drug: LTT462

Study type: Interventional

Funder types: Industry

Identifiers

NCT02711345

CLTT462X2101

2015-003614-24 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 65 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 5 patient groups

Escalation

Experimental group

Treatment:

Drug: LTT462

Expansion Group 1

Experimental group

Treatment:

Drug: LTT462

Expansion Group 2

Experimental group

Treatment:

Drug: LTT462

Expansion Group 3

Experimental group

Treatment:

Drug: LTT462

Expansion Group 4

Experimental group

Treatment:

Drug: LTT462