This study is currently recruiting participants.
Number
14-C-0128
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Enrolling by Invitation Gender: Male & Female Min Age: 2 Years Max Age: N/A
Referral Letter Required
Yes
Population Exclusion(s)
Pregnant Women;Fetuses;Neonates
Keywords
PK; Natural History
Recruitment Keyword(s)
None
Condition(s)
Cancer; Solid Tumors; Neoplasm
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Cancer Institute
- 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.
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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.
- 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.
Principal Investigator
Referral Contact
For more information: