A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Oral Tomivosertib (eFT-508) in Subjects With Hematological Malignancies
NCT ID: NCT02937675
Last Updated: 2020-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1/PHASE2
28 participants
INTERVENTIONAL
2017-02-08
2019-04-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tomivosertib (eFT-508) Escalation Cohort
This portion of the study will evaluate the safety and pharmacology of a range of Tomivosertib (eFT-508) doses administered daily in subjects with previously treated lymphomas
Tomivosertib (eFT-508)
eFT508
Tomivosertib (eFT-508) Expansion Cohort
This portion of the study provides cohort expansion to further explore the safety, pharmacology, and clinical activity of a single dose level of Tomivosertib (eFT-508) monotherapy in subjects with specific previously treated lymphomas
Tomivosertib (eFT-508)
eFT508
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tomivosertib (eFT-508)
eFT508
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Presence of an active hematological malignancy.
3. Presence of measurable disease.
4. 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.
5. At least 2 weeks post any treatments/therapies at the time of first dose.
6. Adequate bone marrow function.
7. Adequate hepatic function.
8. Adequate renal function.
9. Normal coagulation panel.
10. Negative antiviral serology.
11. Willingness to use effective contraception.
Exclusion Criteria
2. Gastrointestinal disease
3. Significant cardiovascular disease
4. Significant ECG abnormalities.
5. Ongoing risk for bleeding due to active peptic ulcer disease, bleeding diathesis or requirement for systemic anticoagulation
6. Ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections)
7. Pregnancy or breastfeeding.
8. Major surgery within 4 weeks before the start of study therapy.
9. Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids
10. Use of drugs that could prolong the QT interval within 7 days before the start of study therapy.
11. Use of drugs that might pose a risk of a drug-drug interaction within 2-7 days before the start of study therapy.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Effector Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jeremy Barton, MD
Role: STUDY_DIRECTOR
CMO
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
eFT508-0002
Identifier Type: -
Identifier Source: org_study_id