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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-15

Study Completion Date

2018-11-21

Brief Summary

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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Escalation

Group Type EXPERIMENTAL

LTT462

Intervention Type DRUG

ERK Inhibitor

Expansion Group 1

Group Type EXPERIMENTAL

LTT462

Intervention Type DRUG

ERK Inhibitor

Expansion Group 2

Group Type EXPERIMENTAL

LTT462

Intervention Type DRUG

ERK Inhibitor

Expansion Group 3

Group Type EXPERIMENTAL

LTT462

Intervention Type DRUG

ERK Inhibitor

Expansion Group 4

Group Type EXPERIMENTAL

LTT462

Intervention Type DRUG

ERK Inhibitor

Interventions

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LTT462

ERK Inhibitor

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No