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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02937675
• Other study ID #: eFT508-0002
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: February 8, 2017
• Est. completion date: April 4, 2019

Study information

• Verified date: November 2018
• Source: Effector Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: April 4, 2019
• Est. primary completion date: November 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Lymphoma

Intervention

Drug:
• Tomivosertib (eFT-508)
eFT508

Locations

Country	Name	City	State
United States	Gabrail Cancer Center Research	Canton	Ohio
United States	Baylor Scott & White Research Institute	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Samuel Oschin comprehensive Cancer Institute at Cedars-Sinai Medical Center	Los Angeles	California
United States	West Virginia University	Morgantown	West Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	Florida Cancer Specialist	Sarasota	Florida
United States	Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Effector Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose and/or Recommended Dose within the tested Tomivosertib (eFT-508) dose range		up to one year
Primary	Overall Response Rate		up to three years