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Side Effects of Vascular Endothelial Growth Factor (VEGF) and Epidermal Growth Factor Receptor (EGFR) Directed Therapy (Mabtornib)

This study has been terminated.
(slow inclusion rate)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00657098
First Posted: April 14, 2008
Last Update Posted: October 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
J.A. Gietema, University Medical Center Groningen
  Purpose
Angiogenesis inhibitors and EGFR inhibitors not only have anti tumor activity but also modify physiological processes. This study evaluates effects on vascular function, endocrine function and metabolism. Changes in these parameters will be analysed for predictive value for treatment efficacy.

Condition
Metastatic Malignancies

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mabtornib Protocol.Vascular, Metabolic and Hormonal Effects of Angiogenesis Inhibitors and Epidermal Growth Factor Receptor Inhibitors

Resource links provided by NLM:


Further study details as provided by J.A. Gietema, University Medical Center Groningen:

Primary Outcome Measures:
  • Characteristics, frequency and severity of vascular, metabolic and hormonal side effects of angiogenesis and EGFR inhibitors. [ Time Frame: after 3 and after 6 weeks of treatment ]
    Vascular function tests at baseline, after 3 and after 6 weeks of treatment, blood and urine measurements as long as treatment is continued.


Secondary Outcome Measures:
  • DNA analysis [ Time Frame: day -7 till day -1 ]

Biospecimen Retention:   Samples With DNA
Serum Plasma Urine DNA

Enrollment: 73
Study Start Date: March 2008
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observation

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who will be treated with angiogenesis inhibitors or EGFR inhibitors
Criteria

Inclusion Criteria:

  • Patients who will start with an angiogenesis inhibitor or EGFR inhibitor
  • Concomittant chemotherapy, immunotherapy or radiotherapy is allowed
  • Age above 18 years at start of treatment
  • Willingness to give written informed consent

Exclusion Criteria:

  • Unable to give written informed consent
  • Age under 18 years
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00657098


Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Center Groningen
Investigators
Principal Investigator: Jourik A Gietema, MD/PhD University Medical Center Groningen, The Netherlands
  More Information

Responsible Party: J.A. Gietema, Principal Investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT00657098     History of Changes
Other Study ID Numbers: 2007/203
First Submitted: April 8, 2008
First Posted: April 14, 2008
Last Update Posted: October 6, 2015
Last Verified: October 2015

Keywords provided by J.A. Gietema, University Medical Center Groningen:
Side effects
Angiogenesis inhibitors
Epidermal growth factor receptor inhibitors
Tyrosinekinase inhibitors

Additional relevant MeSH terms:
Mitogens
Endothelial Growth Factors
Angiogenesis Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Angiogenesis Modulating Agents
Growth Inhibitors
Antineoplastic Agents