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Triple Negative Breast CancerPhase 2NCT03318562

A PD Study of Oral eFT508 in Subjects With Advanced TNBC and HCC

A Phase 2 study testing eFT508 in people with Triple Negative Breast Cancer and Hepatocellular Carcinoma, run by Effector Therapeutics at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will evaluate the pharmacodynamic (PD), safety, antitumor activity, and PK of eFT508 in female subjects who have pathologically documented, radiographically measurable, metastatic or locally advanced and unresectable TNBC and have received prior cancer therapy regimen for metastatic disease, and in male and… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
eFT508
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
2 sitesUnited States
Study dates
21 Nov 2017to 22 Jan 2019
Phase
Phase 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

  • Women ≥18 years of age
  • Pathologically documented diagnosis of TNBC that is metastatic or locally advanced and unresectable
  • Adequate hepatic function and coagulation profile
  • Negative HIV, HBV and HCV
  • Men or Women ≥18 years of age
  • Histological or cytological confirmed diagnosis of HCC with Barcelona Clinic Liver Cancer Stage B or C who cannot benefit from resection, local ablation, or chemoembolization
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  • ECOG performance status of 0 or 1
  • Has at least 1 measurable lesion based on irRECIST 1.1.
  • Negative HIV tests
  • subject agrees to undergo a pre-treatment and an on-treatment biopsy of the tumor
  • Completion of all previous therapy for the treatment of cancer ≥3 weeks before the start of study drug
  • All acute toxic effects of any prior antitumor therapy resolved to Grade ≤1 before the start of study drug
  • Adequate bone marrow and renal function
  • Life expectancy of ≥3 months

Who cannot join

  • Pregnant or breastfeeding
  • History of another malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin; in situ cervical carcinoma; adequately treated, papillary, noninvasive bladder cancer; other adequately treated Stage 1 or 2 cancers currently in complete remission; or any other cancer that has been in complete remission for ≥2 years.
  • Gastrointestinal disease that may interfere with drug absorption or with interpretation of GI AEs.
  • Known symptomatic brain metastases requiring ≥10 mg/day of prednisolone (or its equivalent).
  • Significant cardiovascular disease within 6 months prior to start of study drug
  • Ongoing risk for bleeding due to active peptic ulcer disease or bleeding diathesis or requirement for systemic anticoagulation with unfractionated heparin, low-molecular-weight heparin or heparin fractions, or oral anticoagulants.
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  • Evidence of an ongoing systemic bacterial, fungal, or viral infection
  • Has received a live vaccine within 30 days of planned start of study drug
  • Major surgery within 4 weeks before the start of study drug
  • Prior solid organ or bone marrow progenitor cell transplantation
  • Prior therapy with any known inhibitor of MNK1 or MNK2
  • Prior high dose chemotherapy requiring stem cell rescue
  • History of or active autoimmune disorders or other conditions that might impair or compromise the immune system
  • Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids
  • Use of a strong inhibitor or inducer of cytochrome P450 (CYP)3A4 within 7 days prior to the start of study drug or expected requirement for use of a strong CYP3A4 inhibitor or inducer during study participation
  • Need for proton pump inhibitors and histamine H2 blockers
  • Previously received investigational product in a clinical trial within 30 days or within 5 elimination half lives (whichever is longer) prior to the start of study drug, or is planning to take part in another clinical trial while participating in this study
  • HCC Cohort Only: Portal vein invasion at the main portal (Vp4), inferior vena cava, or cardiac involvement of HCC based on imaging.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • City of Hope

    Duarte, California, 91010

  • Kansas City Research Institute

    Kansas City, Missouri, 64131

Other trials in United States

About this study

Official title: A Pharmacodynamic Study of Oral eFT508 in Subjects With Advanced Triple Negative Breast Cancer and Hepatocellular Carcinoma

This study will evaluate the pharmacodynamic (PD), safety, antitumor activity, and PK of eFT508 in female subjects who have pathologically documented, radiographically measurable, metastatic or locally advanced and unresectable TNBC and have received prior cancer therapy regimen for metastatic disease, and in male and female subjects who have histologically or cytologically confirmed advanced HCC not amenable to surgical resection and have failed systemic therapy.

Being tested
eFT508
Medical subject headings
Triple Negative Breast Neoplasms, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eFT508Drug

    200 mg eFT508 dosed BID for 3 week cycles

Study groups in NCT03318562
Study groupRoleWhat they receive
TNBC CohortExperimentalfemale subjects who have pathologically documented, radiographically measurable, metastatic or locally advanced and unresectable TNBC and have received >=1 prior cancer therapy regimen for metastatic disease
Receives: Drug: eFT508
HCC CohortExperimentalmale and female subjects who have histologically or cytologically confirmed advanced HCC not amenable to surgical resection and have failed >=1 systemic therapy, which must include sorafenib, or are intolerant to multikinase inhibitor therapies
Receives: Drug: eFT508

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Level of biomarkers of antitumor activation

    Biomarkers of antitumor immune activation in pre- and on treatment tumor biopsies and peripheral blood cells

    Measured: 28 days

Secondary outcomes (7)

  1. Molecular profiling of circulating lymphocytes and tumor-infiltrating lymphocytes (TILs)

    Includes determination of T cell clonality via T cell receptor sequencing

    Measured: up to 3 years

  2. Levels of eIF4E and phospho-eIF4E

    Assessment of eIF4E and phospho-eIF4E in tumor biopsies by immunohistochemistry, and in circulating peripheral blood cells by phospho-flow cytometry

    Measured: up to 3 years

  3. Number of mutations

    Assessment of mutations will be determined for a subset of known cancer driver genes by sequencing tumor DNA

    Measured: up to 3 years

  4. Objective tumor response

    determined by irRECIST 1.1, defined as the proportion of subjects who achieve a complete response (CR) or partial response (PR)

    Measured: up to 3 years

  5. Progression Free Survival

    as determined by irRECIST 1.1, defined as the interval from the start of study drug to the earlier of the first documentation of disease progression or death from any cause

    Measured: up to 3 years

  6. Proportion of subjects with TEAEs and SAEs

    Measured: up to 3 years

  7. PK plasma concentrations

    taken at the anticipated maximum and minimum plasma concentrations for eFT508

    Measured: up to 21 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2017
  2. Study start21 Nov 2017
  3. Primary completion5 Jul 2018
  4. Study completion22 Jan 2019

Why it stopped: The study was terminated due to change in focus of the development program

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03318562
Sponsor's protocol ID
eFT508-0008
Status last verified
Dec 2017
First submitted
19 Oct 2017
Last updated
18 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing eFT508 in people with Triple Negative Breast Cancer and Hepatocellular Carcinoma, run by Effector Therapeutics at 2 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 14 inclusion and 18 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 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 phase mean?

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: The study was terminated due to change in focus of the development program). 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?

Level of biomarkers of antitumor activation (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03318562.

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 18 Jul 2019.

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