TerminatedPhase 1NCT02711345
Official study title

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

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedLTT462

The study team can explain what participation involves.

Who it may be forOvarian Neoplasms · Non-Small-Cell Lung Carcinoma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 19, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?7 U.S. locations

Locations may change over time.

Who runs it?Novartis Pharmaceuticals

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Novartis Pharmaceuticals
Interventions being studied
Drug: LTT462
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Novartis Investigative SiteNew York, New York
  • Novartis Investigative SiteHouston, Texas
  • Novartis Investigative SiteEssen
  • Novartis Investigative SiteChuo Ku, Tokyo
  • Novartis Investigative SiteSingapore
  • Novartis Investigative SiteBarcelona, Catalonia
  • Novartis Investigative SiteBellinzona

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 19, 2019. Always confirm current availability with the study team.

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