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Castrate-resistant Prostate Cancer (CRPC)Phase 2NCT03690141

An Open-label Study of the Effect of Tomivosertib (eFT508) in Patients With Advanced Castrate-resistant Prostate Cancer

A Phase 2 study testing eFT508 in people with Castrate-resistant Prostate Cancer (CRPC), run by Effector Therapeutics at 10 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 Phase 2 Open-label Study examines the efficacy, safety, tolerability, and pharmacokinetics (PK) of tomivosertib (eFT508) in Patients with advanced CRPC. An Open-label Study Examining the Effect of tomivosertib (eFT508) in Patients with Advanced Castrate-resistant Prostate Cancer (CRPC) Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
eFT508
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
10 sitesUnited States
Study dates
27 Nov 2018to 27 Apr 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men ≥18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Histologically or cytologically confirmed (by clinical site) adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.
  • Ongoing androgen deprivation therapy with a GnRH analog or bilateral orchiectomy (surgical or medical castration).
  • Serum testosterone ≤1.73 nmol/L (50 ng/dL) at screening.
  • PSA progression on treatment with abiraterone and/or enzalutamide and/or apalutamide. PSA progression is defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each determination. PSA value at the screening visit should be ≥2 ng/mL. Patients may also have:
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  • Soft tissue disease progression defined by iRECIST/RECIST 1.1
  • Bone disease
  • Patients receiving bisphosphonate/receptor activator of nuclear factor kappa-Β ligand (RANKL) therapy must have been on stable doses for ≥ 4 weeks before the start of study therapy.
  • Completion of all previous therapy for the treatment of cancer ≥4 weeks before the start of study therapy.
  • All acute toxic effects of any prior anti-tumor therapy resolved to Grade ≤1 before the start of study therapy (with the exception of alopecia [Grade 1 or 2 permitted], neurotoxicity [Grade 1 or 2 permitted], or bone marrow parameters [Grade 1 or 2 permitted with exceptions as noted below]).
  • Adequate bone marrow function:
  • Absolute neutrophil count (ANC) ≥1.0 x 109/L
  • Platelet count ≥75 x 109/L
  • Hemoglobin ≥80 g/L (8.0 g/dL or 4.9 mmol/L)
  • Adequate hepatic function:
  • Serum alanine aminotransferase (ALT) ≤3 x upper limit of normal (ULN), ≤ 5 x ULN in the presence of liver metastases
  • Serum aspartate aminotransferase (AST) ≤3 x ULN, ≤5 x ULN in presence of liver metastases
  • Serum bilirubin ≤1.5 x ULN (unless due to Gilbert's syndrome or hemolysis ≤3 x ULN)
  • Adequate renal function:
  • -Serum creatinine ≤1.5 mg/dL and/or creatinine clearance ≥30 mL/min using Cockcroft Gault equation (Appendix 13.4)
  • For male patients who can father a child and are having intercourse with females of childbearing potential, willingness to use a protocol-recommended method of contraception from the start of study therapy and for ≥30 days following the last dose of study medication or to abstain from sexual intercourse for at least this period of time, and willingness to refrain from sperm donation from the start of study therapy to ≥90 days following the last dose of study drug.
  • Estimated life expectancy >12 weeks.
  • Willingness to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests and biopsies, other study procedures, and study restrictions. Note: Psychological, social, familial, or geographical factors that might preclude adequate study participation should be considered.
  • Evidence of a personally signed informed consent indicating that the patient is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, possible side effects, potential risks and discomforts, and other pertinent aspects of study participation.

Who cannot join

  • History of another malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin; 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.
  • Rapidly progressive, clinically unstable central nervous system malignancy. Note: Central nervous system imaging is only required in patients with known or suspected central nervous system malignancy.
  • Significant cardiovascular disease, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism within 6 months before the start of study therapy; symptomatic dysrhythmias or unstable dysrhythmias requiring medical therapy; unstable angina; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; Grade ≥3 hypertension (diastolic blood pressure ≥100 mmHg or systolic blood pressure ≥160 mmHg), or history of congenital prolonged QT syndrome.
  • Significant screening electrocardiogram (ECG) abnormalities, including unstable cardiac arrhythmia requiring medication, left bundle-branch block, 2nd-degree atrioventricular (AV) block type II, 3rd-degree AV block, Grade ≥2 bradycardia, or QTcF ≥470 msec.
  • Symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable.
  • Patients with gastrointestinal disorders likely to interfere with absorption of study medication.
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  • Major surgery within 4 weeks before the start of study therapy.
  • Prior treatment with chemotherapy within 3 weeks or at least 4 half-lives, whichever is longer, before the start of study therapy.
  • Prior therapy with any known inhibitor of MNK-1 or MNK-2.
  • Treatment with 5-alpha reductase inhibitors within 4 weeks of enrollment.
  • Prior flutamide treatment within 4 weeks before the start of study therapy and evidence of withdrawal response.
  • Bicalutamide or nilutamide within 6 weeks before the start of study therapy and evidence of withdrawal response.
  • Enzalutamide or abiraterone or apalutamid within 4 weeks before the start of study therapy.
  • Steroids given in conjunction with abiraterone must be washed out for at least 2 weeks prior to Cycle 1 Day 1 unless the investigator chooses to maintain at a dose of ≤10 mg/day prednisone or equivalent.
  • Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (eg, saw palmetto).
  • Current use of immunosuppressive medication at the time of randomization, EXCEPT for the following:
  • intranasal, inhaled, topical steroids, or local steroid injection (eg, intra-articular injection);
  • Systemic corticosteroids at physiologic doses ≤10 mg/day of prednisone or equivalent;
  • Steroids as premedication for hypersensitivity reactions (eg, computed tomography [CT] scan premedication).
  • Use of a potent inhibitor or inducer of cytochrome P450 (CYP) 3A4 within 7 days before the start of study therapy or expected requirement for use of a CYP3A4 inhibitor or inducer during study therapy (Appendix 13.5).
  • Concurrent participation in another therapeutic clinical trial.
  • Any illness, medical condition, organ system dysfunction, or social situation, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Kimmel Center at Johns Hopkins

    Baltimore, Maryland, 21205

  • Northwestern University

    Chicago, Illinois, 60611

  • The Urology Group

    Cincinnati, Ohio, 45212

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Lancaster Urology

    Lancaster, Pennsylvania, 17604

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Yale Cancer Center

    New Haven, Connecticut, 06510

  • University of Washington

    Seattle, Washington, 89109

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase 2 Non-randomized Open-label Study Examining the Effect of Tomivosertib (eFT508) in Patients With Advanced Castrate-resistant Prostate Cancer (CRPC)

This Phase 2 Open-label Study examines the efficacy, safety, tolerability, and pharmacokinetics (PK) of tomivosertib (eFT508) in Patients with advanced CRPC.

An Open-label Study Examining the Effect of tomivosertib (eFT508) in Patients with Advanced Castrate-resistant Prostate Cancer (CRPC)

Read the detailed description

This Phase 2 study examines the efficacy, safety, tolerability, and pharmacokinetics (PK) of tomivosertib (eFT508) in advanced CRPC patients who have documented PSA progression on treatment with apalutamide and/or abiraterone and/or enzalutamide and for whom no suitable curative therapy exists.

Being tested
eFT508
Keywords
Prostate Cancer, Castrate-resistant Prostate Cancer, CRPC, eFT508, eFT508-0009, tomivosertib
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • eFT508Drug

    Also called tomivosertib

    This Phase 2 study examines the efficacy, safety, tolerability, and PK of tomivosertib (eFT508) in advanced CRPC patients who have documented PSA progression on treatment with apalutamide and/or abiraterone and/or enzalutamide and for whom no suitable curative therapy exists.

Study groups in NCT03690141
Study groupRoleWhat they receive
tomivosertib (eFT508)ExperimentalTomivosertib (eFT508) is a novel small-molecule, investigational drug being developed by eFFECTOR Therapeutics, Inc. as an anticancer therapy. Tomivosertib (eFT508) down regulates AR and acts by inhibiting mitogen-activated protein kinase-interacting serine/threonine kinase-1 (MNK1) and MNK2.
Receives: Drug: eFT508

What is being measured

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

  1. Anti-tumor Response as Defined by a Patient Achieving Either of the Following Outcomes:

    • A ≥50% PSA decline from baseline at any time point after therapy and maintained for ≥4 weeks
    • Objective response according to iRECIST 1.1

    Measured: 52 weeks

Secondary outcomes (1)

  1. PSA Progression-free Survival From Start of Study Therapy Until the Date PSA Progression is First Observed.

    PSA progression is defined as a ≥25% increase in PSA from nadir or baseline (and by ≥2 ng/mL) and requires confirmation ≥3 weeks later.

    Measured: 52 weeks

Timeline

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

  1. First posted1 Oct 2018
  2. Study start27 Nov 2018
  3. Primary completion27 Apr 2020
  4. Study completion27 Apr 2020

Why it stopped: Terminated early due to a lack of efficacy.

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
Not applicable
Intervention model
Single group
Model description
tomivosertib (eFT508) will be supplied as 100-mg capsules by the Sponsor. Capsules are packaged in 200-cc high-density polyethylene wide-mouth, round, white bottles, at either 100 or 150 units per bottle, induction sealed and capped with a 38-mm child-resistant closure.
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03690141
Sponsor's protocol ID
eFT508-0009
Status last verified
Jun 2024
First submitted
10 Sep 2018
Last updated
21 Jun 2024
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 Castrate-resistant Prostate Cancer (CRPC), 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 25 inclusion and 22 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 21 Jun 2024. 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 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?

Yes. Results are posted in the registry (first posted 21 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Anti-tumor Response as Defined by a Patient Achieving Either of the Following Outcomes: (time frame: 52 weeks). 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 NCT03690141.

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 21 Jun 2024.

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