Collection of Pharmacokinetic Samples From People With Unanticipated Response, Significant Toxici… (NCT02154022) | Clinical Trial Compass
By InvitationNot Applicable
Collection of Pharmacokinetic Samples From People With Unanticipated Response, Significant Toxicity or Concern of Future Toxicity
United States100 participantsStarted 2014-07-31
Plain-language 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 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.
Who can participate
Age range
2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Any individuals 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. (Exception: Participants \<18 years old will not be eligible for probe administration.)
* Ability of subject or a Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
* Individuals 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:
* Individuals 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
* Individuals 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.