A Phase I Study Of ECO-4601 In Patients With Advanced Cancer

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2006-06-15	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2008-07-10
First Submitted that Met QC Criteria 2006-06-16	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2008-07-15
First Posted (ESTIMATED) 2006-06-20	Results First Posted N/A	Last Verified 2008-07

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: ECO-4601	DRUG: ECO-4601 Continuous IV infusion for 14 days with 7 days recovery (21 day cycle)

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: ECO-4601

DRUG: ECO-4601

Continuous IV infusion for 14 days with 7 days recovery (21 day cycle)

Primary Outcome Measures	Measure Description	Time Frame
Safety/tolerability of ECO-4601
Determination of MTD of ECO-4601
Determination of recommended dose for future studies of ECO-4601

Secondary Outcome Measures	Measure Description	Time Frame
Pharmacokinetics of ECO-4601
Safety of multiple cycles of administration of ECO-4601
Documentation of ECO-4601 antitumor activity as per RECIST criteria

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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
ECOG ≤ 2
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

Hormonal therapy: Patients may have had prior hormonal therapy provided it is discontinued upon ICF signature
Radiation: Patients may have had prior radiation therapy. Patients must have recovered from the acute toxic effects of radiotherapy
Previous surgery: Previous surgery is permitted provided that at least 2 weeks have elapsed between major surgery (non-biopsy) and ICF signature

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
Patients who have been treated with any investigational drug within 4 weeks of patient's signature of informed consent form, or who are receiving concurrent treatment with other experimental drugs or anti cancer therapy
Patients in whom a proper central line cannot be established
Concomitant therapy with therapeutic coumadin; patients can be transferred to low molecular weight heparin
Patients on low molecular weight heparin for < 2 weeks prior to ICF signature
Polysorbate 80 being a major constituent of ECO-4601 and known to cause hypotension, patients with uncontrolled hypotension will be excluded
Known hypersensitivity to farnesylated dibenzodiazepinone or any of the formulation components

Patients may receive ongoing supportive and palliative care (eg: pain control) as clinically indicated throughout the study.
Patients can be treated with corticosteroids if medically needed
Usage of low molecular weight heparin is allowed
Anti seizure products are permitted provided they are not inducers of cytochrome P450.

Other anticancer treatment
Other investigational therapy
Concomitant therapy with coumadin
Cytochrome enzyme inducing anti epileptics
G-CSF, GM-CSF and other growth factors may not be used as a substitute for a scheduled dose reduction; however they may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated at the discretion of the investigator. Use of erythropoietin is allowed if treatment has been initiated for ≥ 2 months. Use of growth factors must be documented on case report forms.
Hormonal therapy

Collaborators and Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Learn

Resources

Patients

Caregivers

Clinical Trial Record