A Dose Escalation and Cohort-Expansion Study of Oral eFT508 in Subjects With Advanced Solid Tumors
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.
Checked against the public recordLast updated Nov 2, 2020 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Effector Therapeutics
- Interventions being studied
- Drug: eFT508
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 2. Pathologically documented diagnosis of advanced solid tumor malignancy that progressed after appropriate prior therapy or has no potential for cure with currently available treatments. 3. Measurable disease defined by Response Evaluation Criteria in Solid Tumors (RECIST) outside of any prior radiation field. 4. At least 3 weeks post any treatments/therapies at the time of first dose. 5. Adequate bone marrow function. 6. Adequate hepatic function. 7. Adequate renal function. 8. Normal coagulation panel. 9. Negative antiviral serology. 10. Willingness to use effective contraception. Exclusion Criteria: 1. Known central nervous system malignancy. 2. Gastrointestinal disease that may interfere with drug absorption. 3. Significant cardiovascular disease. 4. Significant ECG abnormalities. 5. 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. 6. Ongoing systemic bacterial, fungal or viral infection (with the exception of fungal infections of the skin or nails). 7. Pregnancy or breastfeeding. 8. Major surgery within 4 weeks before the start of study therapy. 9. Prior solid organ or bone marrow progenitor cell transplantation. 10. Prior therapy with any known inhibitor of MNK1 or MNK2. 11. Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids (can be using topical or inhaled corticosteroids). 12. Use of drugs that might pose a risk of a drug-drug interaction within 4-7 days before the start of study therapy.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- SCRI at HealthONEDenver, Colorado
- Florida Cancer SpecialistsSarasota, Florida
- Tennessee Oncology, PLLCNashville, Tennessee
- MD Anderson Cancer CenterHouston, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 2, 2020. Always confirm current availability with the study team.