A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Oral Tomivosertib (eFT-508) in Subjects With Hematological Malignancies

Stopped early · Phase 1/Phase 2

Conditions studied: Lymphoma

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 Tomivosertib (eFT-508). The study will evaluate oral daily administration of Tomivosertib (eFT-508). Treatment and study subject evaluation will be performed in 21-day cycles.

Key facts

Study ID

NCT02937675

Run by

Effector Therapeutics

People needed

28

Starts

2017-02-08

Expected to finish

2019-04-04

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.
• Presence of an active hematological malignancy.
• Presence of measurable disease.
• Hematological malignancy has been previously treated, has relapsed after or progressed during prior therapy, and has limited potential for benefit from currently available therapy including hematopoietic stem cell transplantation.
• At least 2 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…

• Central nervous system malignancy
• Gastrointestinal disease
• Significant cardiovascular disease
• Significant ECG abnormalities.
• Ongoing risk for bleeding due to active peptic ulcer disease, bleeding diathesis or requirement for systemic anticoagulation
• Ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections)
• Pregnancy or breastfeeding.
• Major surgery within 4 weeks before the start of study therapy.
• Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids
• Use of drugs that could prolong the QT interval within 7 days before the start of study therapy.
• Use of drugs that might pose a risk of a drug-drug interaction within 2-7 days before the start of study therapy.

Where it is running

• Samuel Oschin comprehensive Cancer Institute at Cedars-Sinai Medical Center — Los Angeles, California, United States
• Florida Cancer Specialist — Sarasota, Florida, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University of Rochester — Rochester, New York, United States
• Gabrail Cancer Center Research — Canton, Ohio, United States
• Baylor Scott & White Research Institute — Dallas, Texas, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• West Virginia University — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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