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



Status:Terminated
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/5/2018
Start Date:October 2016
End Date:November 29, 2018

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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.


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.
We found this trial at
10
sites
825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Principal Investigator: Ajay Gopal, MD
Phone: 206-288-6721
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Paul Barr, MD
Phone: 585-276-8333
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Canton, Ohio 44718
Principal Investigator: Nashat Gabrail, MD
Phone: 330-492-3345
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3505 Gaston Avenue
Dallas, Texas 75246
Principal Investigator: Moshe Levy, MD
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Detroit, Michigan 48201
Principal Investigator: Rod Ramchandren, MD
Phone: 313-576-9772
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Ding Wang, MD
Phone: 313-916-8862
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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8700 Beverly Blvd.
Los Angeles, California 90048
1-800-233-2771
Principal Investigator: Yuliya Linhares, MD
Phone: 310-423-0192
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Cedars-Sinai's Samuel Oschin Comprehensive Cancer Institute...
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Morgantown, West Virginia 26506
(304) 293-0111
Principal Investigator: Abraham Kanate, MD
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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Rochester, Minnesota 55905
Principal Investigator: Nora Bennani, MD
Phone: 507-293-1933
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Sarasota, Florida 34236
Principal Investigator: Manish Patel, MD
Phone: 941-377-9993
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