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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02154022
Status
Enrolling By Invitation

Conditions

  • Cancer
  • Neoplasm
  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Accepted

Study Details

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 participants 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 who are currently enrolled in clinical trials at the NIH Intramural Research Program (IRP). Design: \- Participants will give blood samples.

Key Dates

Start date
Jul 31, 2014
Status verified
May 2026
Primary completion
May 1, 2029
Completion
May 1, 2030

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: 1
    Participants who are currently enrolled in IRB approved NIH Intramural Research Program clinical trial

Primary Outcome Measure

To obtain PK sample [ Time Frame: study completion ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

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National Institutes of Health Clinical Center· Bethesda, MD

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