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A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Oral eFT508 in Subjects With Hematological Malignancies

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ClinicalTrials.gov Identifier: NCT02937675
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : December 21, 2017
Information provided by (Responsible Party):
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 eFT508. The study will evaluate oral daily administration of eFT508. Treatment and study subject evaluation will be performed in 21-day cycles.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: eFT508 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Oral eFT508 in Subjects With Hematological Malignancies
Study Start Date : October 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: eFT508 Escalation Cohort
This portion of the study will evaluate the safety and pharmacology of a range of eFT508 doses administered daily in subjects with previously treated lymphomas
Drug: eFT508
Experimental: eFT508 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 eFT508 monotherapy in subjects with specific previously treated lymphomas
Drug: eFT508

Primary Outcome Measures :
  1. Maximum Tolerated Dose and/or Recommended Dose within the tested eFT508 dose range [ Time Frame: up to one year ]
  2. Overall Response Rate [ Time Frame: up to three years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937675

Contact: Cara Casseday 619-990-8136 ccasseday@effector.com
Contact: Debra T Vallner, PhD, MBA 650-619-0015 dvallner@effector.com

United States, California
Samuel Oschin comprehensive Cancer Institute at Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Tu Nguyen, CRC    310-423-0192    Tu.Nguyen@cshs.org   
Contact: Bethany Wendel, RN    310-967-4339    Bethany.Wendel@cshs.org   
Principal Investigator: Yuliya Linhares, MD         
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Florida Cancer Specialist Recruiting
Sarasota, Florida, United States, 34232
Contact: Donna Jones    615-329-7413    djones@flcancer.com   
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Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Vidya Yarlagadda, MS, CCRP    313-576-9772    yarlagas@karmanos.org   
Contact: Christy Houde    313-576-9381    houdec@karmanos.org   
Principal Investigator: Rod Ramchandren, MD         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Nicole Adams    313-916-8862    nadams9@hfhs.org   
Contact: Kris Strzalkowsi    313-916-7450    kstrzal1@hfhs.org   
Principal Investigator: Ding Wang, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Dawn Deno       Deno.Dawn@mayo.edu   
Principal Investigator: Nora Bennani, MD         
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Frances Batarse, MS    585-275-5825    Frances_Batarse@urmc.rochester.edu   
Principal Investigator: Paul Barr, MD         
United States, Ohio
Gabrail Cancer Center Research Recruiting
Canton, Ohio, United States, 44718
Contact: Anne O'Malley    330-492-3345 ext 208    csmith@gabrailcancercenter.com   
Contact: Hannah Crocker    330-492-3345 ext 207    hcrocker@gabrailcancercenter.com   
Principal Investigator: Nashat Gabrail, MD         
United States, Texas
Baylor Scott & White Research Institute Recruiting
Dallas, Texas, United States, 75246
Contact: Erica Goetz, RN       Erica.Goetz@BSWHealth.org   
Principal Investigator: Moshe Levy, MD         
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Heather Rasmussen, BS, CCRC    206-288-7140    hrasmuss@seattlecca.org   
Principal Investigator: Ajay Gopal, MD         
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Sylvia McEwuen       smcewuen@hsc.wvu.edu   
Principal Investigator: Abraham Kanate, MD         
Sponsors and Collaborators
Effector Therapeutics
Study Director: Jeremy Barton, MD CMO

Responsible Party: Effector Therapeutics
ClinicalTrials.gov Identifier: NCT02937675     History of Changes
Other Study ID Numbers: eFT508-0002
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017

Keywords provided by Effector Therapeutics:
small molecule inhibitor of protein translation
phase 1 dose escalation