A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Oral Tomivosertib (eFT-508) in Subjects With Hematological Malignancies
- Registration Number
- NCT02937675
- Lead Sponsor
- Effector Therapeutics
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 28
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tomivosertib (eFT-508) Expansion Cohort Tomivosertib (eFT-508) 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) Escalation Cohort Tomivosertib (eFT-508) 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
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose and/or Recommended Dose within the tested Tomivosertib (eFT-508) dose range up to one year Overall Response Rate up to three years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
University of Rochester
🇺🇸Rochester, New York, United States
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
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Gabrail Cancer Center Research
🇺🇸Canton, Ohio, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Baylor Scott & White Research Institute
🇺🇸Dallas, Texas, United States