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

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ClinicalTrials.gov Identifier: NCT02937675
Recruitment Status : Terminated (patient recruitment)
First Posted : October 18, 2016
Last Update Posted : November 2, 2020
Sponsor:
Information provided by (Responsible Party):
Effector Therapeutics

Tracking Information
First Submitted Date  ICMJE October 17, 2016
First Posted Date  ICMJE October 18, 2016
Last Update Posted Date November 2, 2020
Actual Study Start Date  ICMJE February 8, 2017
Actual Primary Completion Date November 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
  • Maximum Tolerated Dose and/or Recommended Dose within the tested Tomivosertib (eFT-508) dose range [ Time Frame: up to one year ]
  • Overall Response Rate [ Time Frame: up to three years ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
  • Maximum Tolerated Dose and/or Recommended Dose within the tested eFT508 dose range [ Time Frame: up to one year ]
  • Overall Response Rate [ Time Frame: up to three years ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Oral Tomivosertib (eFT-508) in Subjects With Hematological Malignancies
Official Title  ICMJE A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Oral Tomivosertib (eFT-508) in Subjects With Hematological Malignancies
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE Drug: Tomivosertib (eFT-508)
eFT508
Study Arms  ICMJE
  • 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
    Intervention: 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
    Intervention: Drug: Tomivosertib (eFT-508)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 16, 2019)
28
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2016)
96
Actual Study Completion Date  ICMJE April 4, 2019
Actual Primary Completion Date November 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02937675
Other Study ID Numbers  ICMJE eFT508-0002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Effector Therapeutics
Study Sponsor  ICMJE Effector Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jeremy Barton, MD CMO
PRS Account Effector Therapeutics
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP