Clinical Trials /

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

NCT02711345

Description:

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

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

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

Title

  • Brief Title: A Phase I Clinical Study With Investigational Compound LTT462 in Adult Patients With Specific Advanced Cancers
  • Official Title: A Phase I Dose Finding Study of Oral LTT462 in Adult Patients With Advanced Solid Tumors Harboring MAPK Pathway Alterations
  • Clinical Trial IDs

    NCT ID: NCT02711345

    ORG ID: CLTT462X2101

    NCI ID: 2015-003614-24

    Trial Conditions

    Ovarian Neoplasms

    Non-Small-Cell Lung Carcinoma

    Melanoma

    Other Solid Tumors

    Trial Interventions

    Drug Synonyms Arms
    LTT462 Escalation, Expansion Group 1, Expansion Group 2, Expansion Group 3, Expansion Group 4

    Trial Purpose

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

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Escalation Experimental LTT462
    Expansion Group 1 Experimental LTT462
    Expansion Group 2 Experimental LTT462
    Expansion Group 3 Experimental LTT462
    Expansion Group 4 Experimental LTT462

    Eligibility Criteria

    Inclusion Criteria:

    - Patient (male or female) 18 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 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.

    - Clinically significant cardiac disease.

    Other protocol-defined exclusion criteria may apply.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Safety and tolerability as assessed by incidence and severity of adverse events (AEs), dose interruptions, reductions, and dose intensity

    Incidence and nature of dose limiting toxicities (DLTs) (dose escalation only)

    Secondary Outcome Measures

    Overall response rate (ORR)

    Disease Control Rate (DCR)

    Duration of Response (DOR)

    Progression Free Survival (PFS)

    Overall survival (OS) - only for dose expansion phase

    Plasma concentrations of LTT462

    Derived PK parameters of LTT462: Area under the curve (AUC)

    Derived PK parameters of LTT462: Peak Plasma Concentration (Cmax)

    Derived PK parameters of LTT462: Time to Peak Plasma Concentration (Tmax)

    Derived PK parameters of LTT462: half-life (T1/2)

    Changes from baseline of the PD marker DUSP6 in tumor tissue and in blood - dose expansion only

    Trial Keywords

    LTT462

    ERK

    MAPK

    solid tumor