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

Stopped early · Phase 1/Phase 2

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT02605083

Run by

Effector Therapeutics

People needed

66

Starts

2015-12-03

Expected to finish

2019-03-22

Last updated by the study team

2020-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Known central nervous system malignancy.
• Gastrointestinal disease that may interfere with drug absorption.
• Significant cardiovascular disease.
• Significant ECG abnormalities.
• 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.
• Ongoing systemic bacterial, fungal or viral infection (with the exception of fungal infections of the skin or nails).
• Pregnancy or breastfeeding.
• Major surgery within 4 weeks before the start of study therapy.
• Prior solid organ or bone marrow progenitor cell transplantation.
• Prior therapy with any known inhibitor of MNK1 or MNK2.
• Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids (can be using topical or inhaled corticosteroids).
• Use of drugs that might pose a risk of a drug-drug interaction within 4-7 days before the start of study therapy.

Where it is running

• SCRI at HealthONE — Denver, Colorado, United States
• Florida Cancer Specialists — Sarasota, Florida, United States
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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