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Collection of Pharmacokinetic Samples From People With Unanticipated Response or Toxicity

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ClinicalTrials.gov Identifier: NCT02154022
Recruitment Status : Recruiting
First Posted : June 3, 2014
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

Background:

- Certain drugs - even when they are meant to help people - cause side effects. These are unwanted effects of the drug. There are many reasons why a drug might cause side effects in one person and not in another. It may be because of how much of the drug is in the person s blood at one time. Researchers want to study the blood of people having drug side effects to better understand why they happen.

Objective:

- To obtain blood samples from patients being treated with an investigational or FDA approved drug at the NIH who are having bad side effects that are thought to be due to large amount of the drug in their blood. The samples will be used to assess the cause of the side effects.

Eligibility:

- People 2 years and older with cancer who are currently enrolled in clinical trials at the NIH Intramural Research Program (IRP).

Design:

  • Participants will give blood samples.

Condition or disease
Cancer Solid Tumors Neoplasm

Detailed Description:

Background:

  • Pharmacology is the study of pharmaceutical compounds , and encompasses several parameters, including how the body handles the substance (pharmacokinetics, PK), what the substance does to the body at the molecular level (pharmacodynamics), overall efficacy (response), and any adverse events or toxicity encountered.
  • The Clinical Pharmacology Program (CPP) within the Center for Cancer Research (CCR) of the National Cancer Institute (NCI) has sensitive, state of the art bioanalytical instrumentation that can accurately and precisely quantitate drug concentrations in plasma.
  • Currently, the CPP can only analyze samples from clinical trials that have explicit instructions (within the Pharmacokinetics section) to do so in the IRB approved protocol.
  • However, clinical trial protocols without a Pharmacokinetics section may still need occasional pharmacokinetic plasma samples drawn and drug concentration measurements performed to help explain unexpected AEs or toxicity.

Objectives:

- To obtain PK plasma samples from patients being treated with an investigational agent or FDA approved therapy at the NIH who are exhibiting toxicity that is believed to be due to high drug concentration in order to assess the cause of the toxicity and adverse events.

Eligibility:

- Any cancer patients who are currently enrolled in IRB approved NIH Intramural Research Program (IRP) clinical trials are eligible.

Design:

  • The CPP will measure the drug plasma concentration (or send the sample out to a third party if the assay is commercially available).
  • The accrual ceiling for this study is 100 patients. The anticipated accrual rate for this protocol is less than 10 patients per year, and based on the accrual ceiling, the duration of accrual and the total study duration is 5 years.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Collection of Pharmacokinetic Samples From Patients With Unanticipated Response or Toxicity
Actual Study Start Date : July 31, 2014
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : May 1, 2025



Primary Outcome Measures :
  1. To obtain PK sample [ Time Frame: study completion ]
    Measure drug concentrations in blood.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any cancer patients greater than or equal to 2 years of age who are currently enrolled in IRB approved NIH Intramural Research Program (IRP) clinical trials are eligible.
Criteria
  • INCLUSION CRITERIA:
  • Any cancer patients greater than or equal to 2 years of age who are currently enrolled in IRB approved NIH Intramural Research Program (IRP) clinical trials are eligible.
  • Ability of subject or a Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.

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): NCT02154022


Contacts
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Contact: Deneise Francis (301) 435-7964 deneise.francis@nih.gov
Contact: William D Figg, Pharm.D. (240) 760-6179 wdfigg@helix.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: William D Figg, Pharm.D. National Cancer Institute (NCI)

Additional Information:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02154022     History of Changes
Other Study ID Numbers: 140128
14-C-0128
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 14, 2019

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
PK