Collection of Pharmacokinetic Samples From People With Unanticipated Response, Significant Toxicity or Concern of Future Toxicity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02154022|
Recruitment Status : Recruiting
First Posted : June 3, 2014
Last Update Posted : March 20, 2020
- 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.
- 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.
- People 2 years and older with cancer who are currently enrolled in clinical trials at the NIH Intramural Research Program (IRP).
- Participants will give blood samples.
|Condition or disease|
|Cancer Solid Tumors Neoplasm|
- 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.
- 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..
- Any cancer patients who are currently enrolled in IRB approved NIH Intramural Research Program (IRP) clinical trials are eligible.
- 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 Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Collection of Pharmacokinetic Samples From Patients With Unanticipated Response, Significant Toxicity or Concern of Future Toxicity|
|Actual Study Start Date :||July 31, 2014|
|Estimated Primary Completion Date :||May 1, 2024|
|Estimated Study Completion Date :||May 1, 2025|
Patients with cancer who are currently enrolled in IRB approved NIH Intramural Research Program clinical trial
- To obtain PK sample [ Time Frame: study completion ]Measure drug concentrations in blood.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02154022
|Contact: Deneise Francis||(240) email@example.com|
|Contact: William D Figg, Pharm.D.||(240) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||William D Figg, Pharm.D.||National Cancer Institute (NCI)|