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Sponsored by: |
Clavis Pharma |
Information provided by: | Clavis Pharma |
ClinicalTrials.gov Identifier: | NCT00498407 |
Patients with histologically or cytologically confirmed metastatic colorectal cancer (CRC) who have failed a first-line chemotherapeutic regimen containing oxaliplatin and 5-fluorouracil (5-FU) with or without bevacizumab, with or without other Investigational Medicinal Products (IMPs), will receive CP-4055 200 mg/m2/day intravenously (IV) on Day 1-5 every four weeks until complete response or disease worsening/progressing.
Condition | Intervention | Phase |
Advanced Colorectal Cancer Colorectal Cancer |
Drug: CP-4055 |
Phase II |
MedlinePlus related topics: | Cancer Colorectal Cancer |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of CP-4055 as Second Line Therapy in Patients With Advanced Colorectal Cancer |
Estimated Enrollment: | 42 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
This is a multicentre clinical study conducted in the United Kingdom. It is an open label study designed to investigate objective response rate (RR), the time to progression (TTP) and the duration of tumor response in patients with colorectal cancer when treated with CP-4055. The quantitative and qualitative toxicities of the treatment will also be assessed.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Concomitant treatment with a non-permitted medication:
Contact: Jean-Michel Gaullier, Ph.D. | +47 24 11 09 50 | jean-michel.gaullier@clavispharma.com |
Contact: Wenche Rasch, Ph.D. | 047 24 11 09 50 | wenche.rasch@clavispharma.com |
United Kingdom | |||||
The Beatson West of Scotland Cancer Centre | Recruiting | ||||
Glasgow, United Kingdom, G12 0YN | |||||
Contact: Jim Cassidy, MBChB, MD +44 141 330 4890 jcass001@udcf.gla.ac.uk | |||||
Principal Investigator: Jim Cassidy, MBChB, MD | |||||
Aberdeen Royal Infirmary, Foresterhill, | Recruiting | ||||
Aberdeen, United Kingdom, AB25 2ZN | |||||
Contact: Leslie Samuel, MD +44 122 455 3499 l.samuel@arh.grampian.scot.nhs.uk | |||||
Macmillan Lead Clinician in Gastro-intestinal Cancer Mount Vernon Cancer Centre | Recruiting | ||||
Northwood, United Kingdom, HA6 2RN | |||||
Contact: Rob Glynne-Jones, MD +44 192 384 4012 rob.glynnejones@nhs.net | |||||
Medical Oncology Dept. of Cancer Studies and Molecular Medicine, Leicester Royal Infirmary | Recruiting | ||||
Leicester, United Kingdom, LEI 5WW | |||||
Contact: Anne Thomas, MD +44 116 258 7602 at107@leicester.ac.uk |
Clavis Pharma |
Principal Investigator: | Jim Cassidy, MBChB, MD | The Beatson West of Scotland Cancer Centre |
Responsible Party: | Clavis Pharma ( Jean-Michel Gaullier ) |
Study ID Numbers: | CP4055-202, Grantor: CDER, IND/IDE Number: NA |
First Received: | July 9, 2007 |
Last Updated: | April 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00498407 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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