Clinical trial · Observational
Collection of Pharmacokinetic Samples From People With Unanticipated Response, Significant Toxicity or Concern of Future Toxicity
Collection of Pharmacokinetic and Probe Substrate Samples From Participants With Unanticipated Response, Significant Toxicity or Concern of Future Toxicity
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Neoplasm | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- Participants who are currently enrolled in IRB approved NIH Intramural Research Program clinical trial
Primary outcomes (1)
- measure
- To obtain PK sample
- timeFrame
- study completion
- description
- Measure drug concentrations in blood.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
Show eligibility criteria text
* 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.
References
Publications (0)
Data not yet available