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Trial record 1 of 1 for:    NCT02937675
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A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Oral Tomivosertib (eFT-508) in Subjects With Hematological Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02937675
Recruitment Status : Terminated (patient recruitment)
First Posted : October 18, 2016
Last Update Posted : November 2, 2020
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 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.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Tomivosertib (eFT-508) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 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 Tomivosertib (eFT-508) in Subjects With Hematological Malignancies
Actual Study Start Date : February 8, 2017
Actual Primary Completion Date : November 12, 2018
Actual Study Completion Date : April 4, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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
Drug: Tomivosertib (eFT-508)

Experimental: 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
Drug: Tomivosertib (eFT-508)

Primary Outcome Measures :
  1. Maximum Tolerated Dose and/or Recommended Dose within the tested Tomivosertib (eFT-508) 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, Older Adult)
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 identifier (NCT number): NCT02937675

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United States, California
Samuel Oschin comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Florida
Florida Cancer Specialist
Sarasota, Florida, United States, 34232
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, Ohio
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
United States, Texas
Baylor Scott & White Research Institute
Dallas, Texas, United States, 75246
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Effector Therapeutics
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Study Director: Jeremy Barton, MD CMO
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Responsible Party: Effector Therapeutics Identifier: NCT02937675    
Other Study ID Numbers: eFT508-0002
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: November 2, 2020
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Effector Therapeutics:
small molecule inhibitor of protein translation
phase 1 dose escalation
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases