LymphomaPhase 1/2NCT02937675
A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Oral Tomivosertib (eFT-508) in Subjects With Hematological Malignancies
A Phase 1/2 study testing Tomivosertib (eFT-508) in people with Lymphoma, run by Effector Therapeutics at 10 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Tomivosertib (eFT-508)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 10 sitesUnited States
- Study dates
- 8 Feb 2017to 4 Apr 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Adequate hepatic function.
- Adequate renal function.
- Normal coagulation panel.
- Negative antiviral serology.
- Willingness to use effective contraception.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Gabrail Cancer Center Research
Canton, Ohio, 44718
Baylor Scott & White Research Institute
Dallas, Texas, 75246
Karmanos Cancer Institute
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
Samuel Oschin comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, 90048
West Virginia University
Morgantown, West Virginia, 26506
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester
Rochester, New York, 14642
Florida Cancer Specialist
Sarasota, Florida, 34232
Seattle Cancer Care Alliance
Seattle, Washington, 98109
About this study
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.
- Conditions
- Lymphoma
- Being tested
- Tomivosertib (eFT-508)
- Keywords
- small molecule inhibitor of protein translation, immunomodulator, phase 1 dose escalation
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tomivosertib (eFT-508)Drug
eFT508
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Tomivosertib (eFT-508) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose and/or Recommended Dose within the tested Tomivosertib (eFT-508) dose range
Measured: up to one year
Overall Response Rate
Measured: up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study start8 Feb 2017
- Primary completion12 Nov 2018
- Study completion4 Apr 2019
Why it stopped: patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Effector Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeremy Barton, MD, Study director, CMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937675
- Sponsor's protocol ID
- eFT508-0002
- Status last verified
- Nov 2018
- First submitted
- 17 Oct 2016
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Oral Tomivosertib (eFT-508) in Subjects With Hematological Malignancies
- ClinicalTrials.gov ID
- NCT02937675
- Acronym / sponsor ID
- eFT508-0002
- Conditions
- Lymphoma
- Keywords
- small molecule inhibitor of protein translation, immunomodulator, phase 1 dose escalation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: patient recruitment
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Effector TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 12 Nov 2018 (actual)
- Study completion
- 4 Apr 2019 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tomivosertib (eFT-508) Escalation Cohort | Experimental | Drug: Tomivosertib (eFT-508)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 |
| Tomivosertib (eFT-508) Expansion Cohort | Experimental | Drug: Tomivosertib (eFT-508)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tomivosertib (eFT-508)eFT508 | Drug | Tomivosertib (eFT-508) Escalation Cohort, Tomivosertib (eFT-508) Expansion Cohort |
Primary outcome
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
Results and safety
The study was stopped early (reason given: patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Barton, MD study director
CMO
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tomivosertib (eFT-508) in people with Lymphoma, run by Effector Therapeutics at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: patient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose and/or Recommended Dose within the tested Tomivosertib (eFT-508) dose range (time frame: up to one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.