Collection of Pharmacokinetic Samples From People With Unanticipated Response, Significant Toxicity or Concern of Future Toxicity

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Enrolling by invitation
CT.gov ID
NCT02154022
Collaborator
(none)
100
Enrollment
1
Location
129
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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 or are anticipated to have 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 DiseaseIntervention/TreatmentPhase

    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 or anticipated altered pharmacokinetics.

    Objectives:
    • To obtain PK plasma samples from patients being treated with an investigational agent or FDA approved therapy at the NIH who are exhibiting or are anticipated to exhibit unusual response or 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 10 years.

    Study Design

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

    Arms and Interventions

    ArmIntervention/Treatment
    1

    Patients with cancer who are currently enrolled in IRB approved NIH Intramural Research Program clinical trial

    Outcome Measures

    Primary Outcome Measures

    1. To obtain PK sample [study completion]

      Measure drug concentrations in blood.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • 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.

    • Patients who have received or are anticipated to receive an investigational agent or

    FDA approved therapy at the NIH who meet one of the following criteria:
    • Patients in whom altered pharmacokinetics are anticipated to occur based on pharmacogenetics, history of toxicities with similar agents, drug interactions, or other patient-specific factors which may alter absorption, distribution, metabolism, or excretion. OR

    • Patients who are exhibiting unusual response or toxicity that is believed to be due to high drug concentration in order to assess the cause of toxicity and adverse events.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1National Institutes of Health Clinical Center, 9000 Rockville PikeBethesdaMarylandUnited States20892

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: William D Figg, Pharm.D., National Cancer Institute (NCI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT02154022
    Other Study ID Numbers:
    • 140128
    • 14-C-0128
    First Posted:
    Jun 3, 2014
    Last Update Posted:
    Nov 18, 2021
    Last Verified:
    Nov 16, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Cancer Institute (NCI)

    Study Results

    No Results Posted as of Nov 18, 2021