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A Phase I Study of ECO-4601 in Patients With Advanced Cancer
This study has been completed.
Sponsored by: Thallion Pharmaceuticals
Information provided by: Thallion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00338026
  Purpose

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.


Condition Intervention Phase
Tumors
Glioma
Colorectal Cancer
Lung Cancer
Breast Cancer
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Drug: ECO-4601
Phase I

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Colorectal Cancer Lung Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: 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

Further study details as provided by Thallion Pharmaceuticals:

Primary Outcome Measures:
  • Safety/tolerability of ECO-4601
  • Determination of MTD of ECO-4601
  • Determination of recommended dose for future studies of ECO-4601

Secondary Outcome Measures:
  • Pharmacokinetics of ECO-4601
  • Safety of multiple cycles of administration of ECO-4601
  • Documentation of ECO-4601 antitumor activity as per RECIST criteria

Enrollment: 26
Study Start Date: February 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ECO-4601: Experimental Drug: ECO-4601
Continuous IV infusion for 14 days with 7 days recovery (21 day cycle)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00338026

Locations
Canada, Quebec
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Hôpital Charles LeMoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Sponsors and Collaborators
Thallion Pharmaceuticals
Investigators
Principal Investigator: Petr Kavan, MD, Ph.D. Sir Mortimer B. Davis - Jewish General Hospital
Principal Investigator: Benoît Samson, MD Hôpital Charles LeMoyne
Study Chair: Gerald Batist, MD Sir Mortimer B. Davis - Jewish General Hospital
  More Information

Responsible Party: Thallion Pharmaceuticals Inc. ( Didier Reymond, MD / Vice-President Medical and Clinical Affairs )
Study ID Numbers: ECO-4601-101
Study First Received: June 15, 2006
Last Updated: July 10, 2008
ClinicalTrials.gov Identifier: NCT00338026  
Health Authority: Canada: Health Canada

Keywords provided by Thallion Pharmaceuticals:
Solid Tumors
Thallion
TLN-4601
Ecopia
ECO-4601
Patients with histologically confirmed solid tumors:
High Grade Glioma
Colorectal
Lung
Breast
Ovarian
Pancreatic
Prostate

Study placed in the following topic categories:
Thoracic Neoplasms
Prostatic Diseases
Genital Neoplasms, Male
Gonadal Disorders
Gastrointestinal Diseases
Pancreatic Neoplasms
Colonic Diseases
Urogenital Neoplasms
Ovarian Diseases
Rectal Diseases
Genital Diseases, Female
Signs and Symptoms
Respiratory Tract Diseases
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Breast Diseases
Endocrine Gland Neoplasms
Ovarian cancer
Digestive System Neoplasms
Ovarian Neoplasms
Skin Diseases
Genital Neoplasms, Female
Endocrine System Diseases
Breast Neoplasms
Genital Diseases, Male
Intestinal Diseases
Intestinal Neoplasms
Neuroectodermal Tumors

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Adnexal Diseases

ClinicalTrials.gov processed this record on January 14, 2009