A Phase I, Dose Finding, Pharmacokinetic, and Safety Study of Continuous IV Infusion of ECO-4601 in Patients With Advanced Cancer Including an Extension Portion to Obtain Safety Data at the Highest Tolerable Dose

Thallion Pharmaceuticals2 sites in 1 country26 target enrollmentFebruary 2006

ConditionsTumors Glioma Colorectal Cancer Lung Cancer Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer

InterventionsECO-4601

DrugsECO-4601

Overview

Phase: Phase 1
Intervention: ECO-4601
Conditions: Tumors
Sponsor: Thallion Pharmaceuticals
Enrollment: 26
Locations: 2
Primary Endpoint: Safety/tolerability of ECO-4601
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study was to determine the maximum tolerated dose (MTD) and the recommended dose for future studies of ECO-4601 administered as a continuous IV infusion for 14 days with 7 days recovery (21 day cycle) in patients with histologically confirmed solid tumors (high grade glioma, colorectal, lung, breast, ovarian, pancreatic and prostate). This study was also designed to determine the clinical pharmacokinetic profile, safety of multiple cycles of administration, and document the antitumor activity of ECO-4601.

Registry

clinicaltrials.gov

Start Date

February 2006

End Date

August 2007

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Thallion Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

•Informed about the study and consent to participate in the study
•Clinically or radiologically documented advanced solid malignancy for which no standard therapy is available, or which has failed standard therapy
•Patients with the following solid tumors: high grade glioma, colorectal, prostate, pancreatic, lung, ovarian and breast carcinoma
•Age ≥ 18 years of age
•Laboratory hematology and biochemistry protocol test result abnormalities ≤ Grade 1, graded using NCI CTCAE version 3.0
•Patients with no chemotherapy during the 4 weeks preceding patients' first dose of ECO-4601 (day 1, cycle 1)
•No other anticancer treatment during the study
•Patients can be receiving stable or decreasing dose of steroids within 2 weeks prior to patient's signature of the informed consent
•Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre
•Previous Therapy

Exclusion Criteria

•Patients with brain metastases
•Unlikely to comply with protocol or difficulty to understand the purpose of the study
•Life expectancy \< 12 weeks
•Clinically significant co-morbid disease, e.g. renal failure, ischemic vascular disease, uncontrolled seizure, dementia
•Any patient with a potentially curable malignancy who has not yet received appropriate standard therapies
•Anti seizure drugs known inducers of cytochrome P450
•Documented HIV, active hepatitis B or C infections
•Patients with active or uncontrolled infections or with serious illnesses or medical conditions, which would not permit the patient to be managed according to protocol
•Pregnant or lactating women; both men and women enrolled on study should be using adequate birth control measures throughout the course of the study. Women of childbearing potential must have a negative serum or urine pregnancy test documented within 14 days prior to registration and at study start
•Inability or refusal to practice contraception during therapy of ECO-4601, unless patient is surgically sterile or woman is postmenopausal for at least 2 years