- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00338026
A Phase I Study of ECO-4601 in Patients With Advanced Cancer
July 10, 2008 updated by: Thallion Pharmaceuticals
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
- Hopital Charles LeMoyne
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Montreal, Quebec, Canada, H3T 1E2
- Sir Mortimer B. Davis Jewish General Hospital
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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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
- 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
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
- 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
Concomitant Therapy Permitted:
- 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.
Concomitant Therapy Not Permitted:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ECO-4601
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Continuous IV infusion for 14 days with 7 days recovery (21 day cycle)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Safety/tolerability of ECO-4601
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Determination of MTD of ECO-4601
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Determination of recommended dose for future studies of ECO-4601
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Secondary Outcome Measures
Outcome Measure |
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Pharmacokinetics of ECO-4601
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Safety of multiple cycles of administration of ECO-4601
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Documentation of ECO-4601 antitumor activity as per RECIST criteria
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Petr Kavan, MD, Ph.D., Sir Mortimer B. Davis - Jewish General Hospital
- Principal Investigator: Benoît Samson, MD, Hopital Charles LeMoyne
- Study Chair: Gerald Batist, MD, Sir Mortimer B. Davis - Jewish General Hospital
Study record dates
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 Major Dates
Study Start
February 1, 2006
Primary Completion (Actual)
August 1, 2007
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
June 15, 2006
First Submitted That Met QC Criteria
June 16, 2006
First Posted (Estimate)
June 20, 2006
Study Record Updates
Last Update Posted (Estimate)
July 15, 2008
Last Update Submitted That Met QC Criteria
July 10, 2008
Last Verified
July 1, 2008
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ECO-4601-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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