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

Stopped early · Phase 1

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

In brief

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

Key facts

Study ID

NCT02711345

Run by

Novartis Pharmaceuticals

People needed

65

Starts

2016-04-15

Expected to finish

2018-11-21

Last updated by the study team

2019-09-19

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — Essen, Germany
• Novartis Investigative Site — Chuo Ku, Tokyo, Japan
• Novartis Investigative Site — Singapore, Singapore
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Bellinzona, Switzerland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.