NCT02937675

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 lymphoma

Timeline
Completed

Started Feb 2017

Shorter than P25 for phase_1 lymphoma

Geographic Reach
1 country

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

February 8, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2019

Completed
Last Updated

November 2, 2020

Status Verified

November 1, 2018

Enrollment Period

1.8 years

First QC Date

October 17, 2016

Last Update Submit

October 30, 2020

Conditions

Lymphoma

Keywords

small molecule inhibitor of protein translationimmunomodulatorphase 1 dose escalation

Outcome Measures

Primary Outcomes (2)

  • Maximum Tolerated Dose and/or Recommended Dose within the tested Tomivosertib (eFT-508) dose range

    up to one year

  • Overall Response Rate

    up to three years

Study Arms (2)

Tomivosertib (eFT-508) Escalation Cohort

EXPERIMENTAL

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)

Tomivosertib (eFT-508) Expansion Cohort

EXPERIMENTAL

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)

Interventions

Tomivosertib (eFT-508)DRUG

eFT508

Tomivosertib (eFT-508) Escalation CohortTomivosertib (eFT-508) Expansion Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Presence of an active hematological malignancy.
  • Presence of measurable disease.
  • 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.
  • At least 2 weeks post any treatments/therapies at the time of first dose.
  • Adequate bone marrow function.
  • Adequate hepatic function.
  • Adequate renal function.
  • Normal coagulation panel.
  • Negative antiviral serology.
  • Willingness to use effective contraception.

You may not qualify if:

  • Central nervous system malignancy
  • Gastrointestinal disease
  • Significant cardiovascular disease
  • Significant ECG abnormalities.
  • Ongoing risk for bleeding due to active peptic ulcer disease, bleeding diathesis or requirement for systemic anticoagulation
  • Ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections)
  • Pregnancy or breastfeeding.
  • Major surgery within 4 weeks before the start of study therapy.
  • Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids
  • Use of drugs that could prolong the QT interval within 7 days before the start of study therapy.
  • Use of drugs that might pose a risk of a drug-drug interaction within 2-7 days before the start of study therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Samuel Oschin comprehensive Cancer Institute at Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Florida Cancer Specialist

Sarasota, Florida, 34232, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

Baylor Scott & White Research Institute

Dallas, Texas, 75246, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Lymphoma

Interventions

tomivosertib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Jeremy Barton, MD

    CMO

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 18, 2016

Study Start

February 8, 2017

Primary Completion

November 12, 2018

Study Completion

April 4, 2019

Last Updated

November 2, 2020

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(10)