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Sponsored by: |
Thallion Pharmaceuticals |
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Information provided by: | Thallion Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00338026 |
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 |
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Tumors Glioma Colorectal Cancer Lung Cancer Breast Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer |
Drug: ECO-4601 |
Phase I |
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 |
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)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Previous Therapy
Exclusion Criteria:
Concomitant Therapy Permitted:
Concomitant Therapy Not Permitted:
Canada, Quebec | |
Sir Mortimer B. Davis Jewish General Hospital | |
Montreal, Quebec, Canada, H3T 1E2 | |
Hôpital Charles LeMoyne | |
Greenfield Park, Quebec, Canada, J4V 2H1 |
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 |
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 |
Solid Tumors Thallion TLN-4601 Ecopia ECO-4601 Patients with histologically confirmed solid tumors: High Grade Glioma |
Colorectal Lung Breast Ovarian Pancreatic Prostate |
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 |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site |
Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Adnexal Diseases |