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

Sponsor
Effector Therapeutics (Industry)
Overall Status
Terminated
CT.gov ID
NCT02937675
Collaborator
(none)
28
Enrollment
10
Locations
2
Arms
25.8
Actual Duration (Months)
2.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Tomivosertib (eFT-508)
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
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 :
Feb 8, 2017
Actual Primary Completion Date :
Nov 12, 2018
Actual Study Completion Date :
Apr 4, 2019

Arms and Interventions

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)
eFT508
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)
eFT508

Outcome Measures

Primary Outcome Measures

  1. Maximum Tolerated Dose and/or Recommended Dose within the tested Tomivosertib (eFT-508) dose range [up to one year]

  2. Overall Response Rate [up to three years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samuel Oschin comprehensive Cancer Institute at Cedars-Sinai Medical Center Los Angeles California United States 90048
2 Florida Cancer Specialist Sarasota Florida United States 34232
3 Karmanos Cancer Institute Detroit Michigan United States 48201
4 Henry Ford Hospital Detroit Michigan United States 48202
5 Mayo Clinic Rochester Minnesota United States 55905
6 University of Rochester Rochester New York United States 14642
7 Gabrail Cancer Center Research Canton Ohio United States 44718
8 Baylor Scott & White Research Institute Dallas Texas United States 75246
9 Seattle Cancer Care Alliance Seattle Washington United States 98109
10 West Virginia University Morgantown West Virginia United States 26506

Sponsors and Collaborators

  • Effector Therapeutics

Investigators

  • Study Director: Jeremy Barton, MD, CMO

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Effector Therapeutics
ClinicalTrials.gov Identifier:
NCT02937675
Other Study ID Numbers:
  • eFT508-0002
First Posted:
Oct 18, 2016
Last Update Posted:
Nov 2, 2020
Last Verified:
Nov 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
immunomodulator
phase 1 dose escalation
Additional relevant MeSH terms:
Hematologic Neoplasms

Study Results

No Results Posted as of Nov 2, 2020