Completed

A First In Man Phase I Study Of EPC2407, A Microtubule Inhibitor Anti-Cancer Drug With Tumor Vascular Endothelial Disrupting Activity: Intravenous Administration Daily For Three Days In Patients With Advanced Solid Tumors And Lymphomas

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What is being tested

EPC2407 (crinobulin)

Drug
Who is being recruted

Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: December 2006
See protocol details

Summary

Principal SponsorEpiCept Corporation
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2006Actual date on which the first participant was enrolled.

This is a Phase I, open label, multicenter, dose-escalation, safety, pharmacokinetic, and pharmacodynamic study of EPC2407 administered intravenously over 60 minutes on a QDx3 schedule repeated every 21 days. Patients are enrolled and dosed at the level defined by the escalation scheme. The primary goal of the study design is to assess toxicity at the fixed dose levels according to the modified Fibonacci schema.

Official TitleA First In Man Phase I Study Of EPC2407, A Microtubule Inhibitor Anti-Cancer Drug With Tumor Vascular Endothelial Disrupting Activity: Intravenous Administration Daily For Three Days In Patients With Advanced Solid Tumors And Lymphomas 
NCT00423410
Principal SponsorEpiCept Corporation
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
30 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Neoplasms
Criteria

Inclusion Criteria: 1. Histologically or cytologically confirmed solid tumor or lymphoma,which has progressed on standard therapies, for which effective therapy is not available or for patients who are unwilling to undergo such therapies. 2. Males and Females at least 18 years of age 3. Laboratory data as specified below (according to the site's clinical laboratory ranges for normal): i. Hematology: ANC \>1500 cells/mm3, platelet count \>100,000 cells/mm3 and Hemoglobin \> 9 gm/L ii. Hepatic: Direct bilirubin \<1.5 X ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 2.5 X ULN. For patients with known liver metastases or liver neoplasms: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 5.0 X ULN iii. Renal: serum creatinine WNL or creatinine clearance \>60 mL/min 4. 12-lead electrocardiogram (ECG) QT intervals: QTc ≤ 450 msec for men and ≤ 470 msec for women. 5. Estimated life expectancy of at least 3 months 6. ECOG Performance Status \< or = 1 7. Previously treated CNS disease allowed if treatment completed and stable for 4 weeks. 8. For men and women of child-producing potential - willingness to employ appropriate contraceptive methods (including abstinence) during the study 9. Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments 10. Cardiac ejection fraction ≥50% by 2D Echocardiogram or \> institutional lower limits of normal Exclusion Criteria: 1. Women who are pregnant or nursing 2. Radiotherapy or any chemotherapy within the previous 21 days or five half lives of prior drug (whichever is shorter). See also exclusion #4 below for patients at risk for cardiac toxicity. Recovery to Grade 1 or less from chemotherapy-induced toxic effect, except alopecia, is required. 3. Major surgery within the last 4 weeks or minor surgery within the last 2 weeks 4. Significant risk of cardiac drug toxicity due to any of the following: a) Active New York Heart Association Class III or IV, b) history of or current congestive heart failure, c) history of myocardial infarction within the last 6 months or ongoing unstable angina, or anthracycline exposure per exclusion #5. 5. Anthracycline exposure exceeding a cumulative dose of 360 mg/m² 6. Known and ongoing HIV, Hepatitis B or Hepatitis C infection 7. Concomitant use of strong inhibitors of the liver microsomal enzymes CYP2C8, CYP2C9, CYP2C19 and CYP3A4. 8. Participation in concurrent study of an investigational agent or device 9. Any other condition including but not limited to major co-morbidities, which in the opinion of the investigator would render the patient ineligible 10. O2 Saturation by pulse oximetry at rest \< 90% 11. Concomitant use of drugs that have significant risk of Torsades de Pointes will also be prohibited. Please refer to drugs listed under "Drugs with Risk of Torsades de Pointes"

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental

IV infusion 1 to 4 hours
Study Objectives
Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 3 locations
Suspended
Scottsdale HealthcareScottsdale, United StatesSee the location
Suspended
Tower Oncology ResearchBeverly Hills, United States
Suspended
Rebecca and John Moores UCSD Cancer CenterSan Diego, United States
Completed3 Study Centers