Clinical trial NCT02937675: A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Oral Tomivosertib (eFT-508) in Subjects With Hematological Malignancies
Official title: A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Oral Tomivosertib (eFT-508) in Subjects With Hematological Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Lymphoma
Keywords: small molecule inhibitor of protein translation
immunomodulator
phase 1 dose escalation
Lead sponsor: Effector Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-10-18
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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:

1. Central nervous system malignancy
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.

Primary outcomes:
measure: Maximum Tolerated Dose and/or Recommended Dose within the tested Tomivosertib (eFT-508) dose range
timeFrame: up to one year
measure: Overall Response Rate
timeFrame: up to three years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Samuel Oschin comprehensive Cancer Institute at Cedars-Sinai Medical Center
state: California
city: Sarasota
country: United States
facility: Florida Cancer Specialist
state: Florida
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: CMO
name: Jeremy Barton, MD
role: STUDY_DIRECTOR
References: