A Dose Escalation and Cohort-Expansion Study of Oral eFT508 in Subjects With Advanced Solid Tumors

NCT02605083 | Terminated Phase 1

• 1 other identifier: eFT508-0001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 4

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 daily oral administration of eFT508.

Conditions

Cancer

Keywords

Cancer; Neoplasm; Solid Tumor; Breast; Head and Neck; Lung; Pancreatic; Hepatic; Melanoma; Colon; Renal; Thyroid; Prostate; Ovarian; MNK1; MNK2; eIF4E

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD)/Recommended dose (RD)

  Up to one year

• Overall response rate (ORR)

  Up to three years

Secondary Outcomes (5)

• Safety (Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE v. 4.03))

  Up to three year

• Plasma concentration of eFT508 as characterized by maximum serum concentration (Cmax)

  Different time points up to 336 hours

• Plasma concentration of eFT508 as characterized by Area Under the Curve (AUC)

  Different time points up to 336 hours

• Changes in eIF4E phosphorylation in peripheral blood cells (PBMCs)

  Up to Day 14

• Tumor control evaluated by modified RECIST criteria v 1.1

  Up to three years

Study Arms (1)

eFT508

EXPERIMENTAL

Escalation cohort

Drug: eFT508

Interventions

eFT508 DRUG

Will be given orally once or twice daily. Each treatment cycle = 21 days.

eFT508

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Pathologically documented diagnosis of advanced solid tumor malignancy that progressed after appropriate prior therapy or has no potential for cure with currently available treatments.
• Measurable disease defined by Response Evaluation Criteria in Solid Tumors (RECIST) outside of any prior radiation field.
• At least 3 weeks post any treatments/therapies at the time of first dose.
• Adequate bone marrow function.
• Adequate hepatic function.
• Adequate renal function.
• Normal coagulation panel.
• Negative antiviral serology.
• Willingness to use effective contraception.

You may not qualify if:

• Known central nervous system malignancy.
• Gastrointestinal disease that may interfere with drug absorption.
• Significant cardiovascular disease.
• Significant ECG abnormalities.
• Ongoing risk of bleeding due to active peptic ulcer disease, bleeding diathesis, or requirement for systemic anticoagulants. Use of heparin or thrombolytic agents for local maintenance or clearance of a central venous catheter is permitted.
• Ongoing systemic bacterial, fungal or viral infection (with the exception of fungal infections of the skin or nails).
• Pregnancy or breastfeeding.
• Major surgery within 4 weeks before the start of study therapy.
• Prior solid organ or bone marrow progenitor cell transplantation.
• Prior therapy with any known inhibitor of MNK1 or MNK2.
• Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids (can be using topical or inhaled corticosteroids).
• Use of drugs that might pose a risk of a drug-drug interaction within 4-7 days before the start of study therapy.

Sponsors & Collaborators

• Effector Therapeutics: lead

Study Sites (4)

SCRI at HealthONE

Denver, Colorado, 80218, United States

Location

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neoplasms; Melanoma; Thyroid Diseases

Interventions

tomivosertib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases

Study Officials

• Jeremy Barton, MD

  Effector Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: November 16, 2015
• Study Start: December 3, 2015
• Primary Completion: January 11, 2019
• Study Completion: March 22, 2019
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)