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A Dose Escalation and Cohort-Expansion Study of Oral eFT508 in Subjects With Advanced Solid Tumors

NCT ID: NCT02605083

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-03

Study Completion Date

2019-03-22

Brief Summary

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This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of daily oral administration of eFT508.

Detailed Description

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eFT508 is an oral, potent and highly selective inhibitor of mitogen-activated protein kinase interacting kinase (MNK) 1 and 2. Dysregulated translation of messenger RNA (mRNA) plays a role in the pathogenesis of multiple solid tumors and hematological malignancies. MNK1 and MNK2 integrate signals from several oncogenic and immune signaling pathways (including RAS, p38 and Toll-like receptors) by phosphorylating eukaryotic initiation of factor 4E (eIF4E) and key effector proteins. Phosphorylation of these regulatory proteins by MNK1 and MNK2 selectively regulates the stability and translation of a subset of cellular mRNA that control tumor growth, the tumor microenvironment and immune signaling. Nonclinical studies indicate that eFT508 shows activity against various types of solid tumors. These nonclinical studies support initiation of clinical development of eFT508 in patients with cancer.

Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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eFT508

Escalation cohort

Group Type EXPERIMENTAL

eFT508

Intervention Type DRUG

Will be given orally once or twice daily. Each treatment cycle = 21 days.

Interventions

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eFT508

Will be given orally once or twice daily. Each treatment cycle = 21 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
2. Pathologically documented diagnosis of advanced solid tumor malignancy that progressed after appropriate prior therapy or has no potential for cure with currently available treatments.
3. Measurable disease defined by Response Evaluation Criteria in Solid Tumors (RECIST) outside of any prior radiation field.
4. At least 3 weeks post any treatments/therapies at the time of first dose.
5. Adequate bone marrow function.
6. Adequate hepatic function.
7. Adequate renal function.
8. Normal coagulation panel.
9. Negative antiviral serology.
10. Willingness to use effective contraception.

Exclusion Criteria

1. Known central nervous system malignancy.
2. Gastrointestinal disease that may interfere with drug absorption.
3. Significant cardiovascular disease.
4. Significant ECG abnormalities.
5. Ongoing risk of bleeding due to active peptic ulcer disease, bleeding diathesis, or requirement for systemic anticoagulants. Use of heparin or thrombolytic agents for local maintenance or clearance of a central venous catheter is permitted.
6. Ongoing systemic bacterial, fungal or viral infection (with the exception of fungal infections of the skin or nails).
7. Pregnancy or breastfeeding.
8. Major surgery within 4 weeks before the start of study therapy.
9. Prior solid organ or bone marrow progenitor cell transplantation.
10. Prior therapy with any known inhibitor of MNK1 or MNK2.
11. Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids (can be using topical or inhaled corticosteroids).
12. Use of drugs that might pose a risk of a drug-drug interaction within 4-7 days before the start of study therapy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Effector Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeremy Barton, MD

Role: STUDY_DIRECTOR

Effector Therapeutics

Locations

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SCRI at HealthONE

Denver, Colorado, United States

Site Status

Florida Cancer Specialists

Sarasota, Florida, United States

Site Status

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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eFT508-0001

Identifier Type: -

Identifier Source: org_study_id