Status:
COMPLETED
Pharmacokinetic Studies Participation Survey
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Relapsed Solid Tumors
Relapsed Leukemia
Eligibility:
All Genders
18-99 years
Brief Summary
Background: * A pharmacokinetic (PK) study of a new drug involves taking several blood samples over a period of time from study participants to determine how the body handles the substance. These stu...
Detailed Description
Background: Pharmacokinetic studies provide critical information about the disposition of anticancer drugs in children. However, participation of children in the pharmacokinetic portion of phase I st...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subjects who consented within the 4 weeks prior to enrollment on this questionnaire study to a Phase 1 study that included optional PK sampling. (If the subject was a minor and a parent or legally authorized representative provided consent, subject for this questionnaire study refers to the parent). The PK questionnaire should be completed within 4 weeks of when the subject consented to the study that included optional PK sampling. (Note: The Phase 1 study need not have been a COG study).
- Subjects are eligible regardless of whether they initially agreed to participate in the PK portion and regardless of whether they actually completed the PK sampling (as long as reason for not completing the sampling was not withdrawal of consent).
- Subjects must not have withdrawn consent to the study that included optional PK sampling.
- Subjects must not have initially agreed to optional PK sampling but then withdrawn consent for sampling prior to completing the questionnaire.
- Subjects are eligible regardless of how many phase 1 or other studies they have enrolled in the past.
- Each subject may participate only once in the survey.
Exclusion
Key Trial Info
Start Date :
September 23 2008
Trial Type :
OBSERVATIONAL
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00923468
Start Date
September 23 2008
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892