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Acetylamantadine Excretion by Cancer Patients

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ClinicalTrials.gov Identifier: NCT02277938
Recruitment Status : Unknown
Verified May 2016 by University of Manitoba.
Recruitment status was:  Recruiting
First Posted : October 29, 2014
Last Update Posted : May 10, 2017
Sponsor:
Collaborators:
BioMark Technologies Inc.
St. Boniface General Hospital Research Centre
Information provided by (Responsible Party):
University of Manitoba

Brief Summary:
Several factors discourage the implementation of cancer screening to the population in general, which would result in earlier diagnosis and an expected improved survival. Concurrent in vivo and in vitro research has shown that drug acetylation activity is increased in cancer. Amantadine may be of value in detecting the presence of cancer. Accordingly, this study will examine how Amantadine is eliminated by the body in cancer patients. This is an important step in validating a cancer detection method that can be implemented economically for screening of large numbers of people.

Condition or disease Intervention/treatment Phase
Cancer Drug: Amantadine Phase 2

Detailed Description:
The study will involve the screening of volunteer patients with various types of cancer to provide a first indication of which types of cancer and at what stage of tumor burden acetylamantadine will be found in patients' plasma, saliva and urine samples. Volunteers will provide complete first morning urine collection prior to amantadine ingestion. The volunteers will then ingest a therapeutic dose of amantadine (200 mg: 2x100mg capsules), at least 2 hours before breakfast (nothing to eat or drink except water after midnight before the scheduled appointment), and their complete urine will be collected at 2 and 4 hours (plus or minus 1 hour) after amantadine ingestion. In addition, blood samples will be taken by venipuncture before and at 2 and 4 hours after drug ingestion. The patients will be asked to provide a saliva sample at the same time as the urine samples are taken after drug ingestion.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Urinary Excretion of Acetylamantadine by Cancer Patients
Study Start Date : August 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Amantadine Drug: Amantadine
Amantadine is a drug that has been on the market for several years and is currently approved for the treatment of Parkinson's disease and for prevention against influenza A infection. Amantadine may be of value in detecting the presence of cancer.




Primary Outcome Measures :
  1. Acetylated Amantadine levels in urine [ Time Frame: 2 and 4 hours after Amantadine ingestion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: newly diagnosed or untreated cancer (GI, lung, prostate and breast cancer)

-

Exclusion Criteria: Any previous adverse reaction to Amantadine

  • currently pregnant or lactating

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): NCT02277938


Contacts
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Contact: Paramjit S Tappia, PhD 204-258-1230 ptappia@sbrc.ca
Contact: Andrew Maksymiuk, MD 204-787-1884 amaksymiuk@cancercare.mb.ca

Locations
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Canada, Manitoba
St. Boniface Hospital Recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contact: Paramjit S Tappia, PhD    204-258-1230    ptappia@sbrc.ca   
Contact: Andrew Maksymiuk, MD    204-7871884    amaksymiuk@cancercare.mb.ca   
Sponsors and Collaborators
University of Manitoba
BioMark Technologies Inc.
St. Boniface General Hospital Research Centre

Publications of Results:

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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT02277938     History of Changes
Other Study ID Numbers: B2012:063
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2016

Additional relevant MeSH terms:
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Amantadine
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents