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A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Oral eFT508 in Subjects With Hematological Malignancies

This study is currently recruiting participants.
Verified March 2017 by Effector Therapeutics
Sponsor:
ClinicalTrials.gov Identifier:
NCT02937675
First Posted: October 18, 2016
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Effector Therapeutics
  Purpose
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 eFT508. The study will evaluate oral daily administration of eFT508. Treatment and study subject evaluation will be performed in 21-day cycles.

Condition Intervention Phase
Lymphoma Drug: eFT508 Phase 1 Phase 2

Study Type: Interventional
Study Design: 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 eFT508 in Subjects With Hematological Malignancies

Resource links provided by NLM:


Further study details as provided by Effector Therapeutics:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 96
Study Start Date: October 2016
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: eFT508 Escalation Cohort
This portion of the study will evaluate the safety and pharmacology of a range of eFT508 doses administered daily in subjects with previously treated lymphomas
Drug: eFT508
Experimental: eFT508 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 eFT508 monotherapy in subjects with specific previously treated lymphomas
Drug: eFT508

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937675


Contacts
Contact: Cara Casseday 619-990-8136 ccasseday@effector.com
Contact: Debra T Vallner, PhD, MBA 650-619-0015 dvallner@effector.com

Locations
United States, Florida
Florida Cancer Specialist Recruiting
Sarasota, Florida, United States, 34232
Contact: Donna Jones    615-329-7413    djones@flcancer.com   
Principal Investigator: Manish Patel, MD         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Vidya Yarlagadda, MS, CCRP    313-576-9772    yarlagas@karmanos.org   
Contact: Christy Houde    313-576-9381    houdec@karmanos.org   
Principal Investigator: Rod Ramchandren, MD         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Nicole Adams    313-916-8862    nadams9@hfhs.org   
Contact: Kris Strzalkowsi    313-916-7450    kstrzal1@hfhs.org   
Principal Investigator: Ding Wang, MD         
United States, Ohio
Gabrail Cancer Center Research Recruiting
Canton, Ohio, United States, 44718
Contact: Anne O'Malley    330-492-3345 ext 208    csmith@gabrailcancercenter.com   
Contact: Hannah Crocker    330-492-3345 ext 207    hcrocker@gabrailcancercenter.com   
Principal Investigator: Nashat Gabrail, MD         
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Heather Rasmussen, BS, CCRC    206-288-7140    hrasmuss@seattlecca.org   
Principal Investigator: Ajay Gopal, MD         
Sponsors and Collaborators
Effector Therapeutics
Investigators
Study Director: Jeremy Barton, MD CMO
  More Information

Responsible Party: Effector Therapeutics
ClinicalTrials.gov Identifier: NCT02937675     History of Changes
Other Study ID Numbers: eFT508-0002
First Submitted: October 17, 2016
First Posted: October 18, 2016
Last Update Posted: March 28, 2017
Last Verified: March 2017

Keywords provided by Effector Therapeutics:
small molecule inhibitor of protein translation
immunomodulator
phase 1 dose escalation