Collection of Pharmacokinetic Samples From People With Unanticipated Response, Significant Toxicity or Concern of Future Toxicity
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 Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 Patients with cancer who are currently enrolled in IRB approved NIH Intramural Research Program clinical trial |
Outcome Measures
Primary Outcome Measures
- To obtain PK sample [study completion]
Measure drug concentrations in blood.
Eligibility Criteria
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.
-
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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Institutes of Health Clinical Center | Bethesda | Maryland | United States | 20892 |
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.- 140128
- 14-C-0128