A Dose Escalation and Cohort-Expansion Study of Oral eFT508 in Subjects With Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT02605083 |
Recruitment Status :
Terminated
(The study was terminated after determination of the RP2D, prior to opening expansion cohorts))
First Posted : November 16, 2015
Last Update Posted : November 2, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancer | Drug: eFT508 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 66 participants |
Allocation: | N/A |
Intervention Model: | Single Group 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 Advanced Solid Tumors |
Actual Study Start Date : | December 3, 2015 |
Actual Primary Completion Date : | January 11, 2019 |
Actual Study Completion Date : | March 22, 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: eFT508
Escalation cohort
|
Drug: eFT508
Will be given orally once or twice daily. Each treatment cycle = 21 days. |
- Maximum tolerated dose (MTD)/Recommended dose (RD) [ Time Frame: Up to one year ]
- Overall response rate (ORR) [ Time Frame: Up to three years ]
- Safety (Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE v. 4.03)) [ Time Frame: Up to three year ]Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE v. 4.03)
- Plasma concentration of eFT508 as characterized by maximum serum concentration (Cmax) [ Time Frame: Different time points up to 336 hours ]
- Plasma concentration of eFT508 as characterized by Area Under the Curve (AUC) [ Time Frame: Different time points up to 336 hours ]
- Changes in eIF4E phosphorylation in peripheral blood cells (PBMCs) [ Time Frame: Up to Day 14 ]
- Tumor control evaluated by modified RECIST criteria v 1.1 [ Time Frame: Up to three years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

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): NCT02605083
United States, Colorado | |
SCRI at HealthONE | |
Denver, Colorado, United States, 80218 | |
United States, Florida | |
Florida Cancer Specialists | |
Sarasota, Florida, United States, 34232 | |
United States, Tennessee | |
Tennessee Oncology, PLLC | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Study Director: | Jeremy Barton, MD | Effector Therapeutics |
Responsible Party: | Effector Therapeutics |
ClinicalTrials.gov Identifier: | NCT02605083 |
Other Study ID Numbers: |
eFT508-0001 |
First Posted: | November 16, 2015 Key Record Dates |
Last Update Posted: | November 2, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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