Collection of Pharmacokinetic Samples From People With Unanticipated Response or Toxicity
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 2 - 99 |
| Updated: | 2/20/2019 |
| Start Date: | July 31, 2014 |
| End Date: | May 1, 2025 |
| Contact: | Deneise Francis |
| Email: | deneise.francis@nih.gov |
| Phone: | (301) 435-7964 |
Collection of Pharmacokinetic Samples From Patients With Unanticipated Response or Toxicity
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 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.
- 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 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.
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.
Objectives:
- To obtain PK plasma samples from patients being treated with an investigational agent or
FDA approved therapy at the NIH who are exhibiting 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 5 years.
- 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.
Objectives:
- To obtain PK plasma samples from patients being treated with an investigational agent or
FDA approved therapy at the NIH who are exhibiting 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 5 years.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 888-624-1937
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