NCT00339664

Analyses of Human Samples Collected in Clinical Trials

Pharmacological Analysis of Human Samples Collected in Clinical Trials Performed Outside of the Intramural National Cancer Institute

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,579 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 100 Years
• Healthy volunteers: Not accepted

Summary

Cancer patients in clinical trials donate various human samples (e.g., serum, plasma, blood, urine, feces, bile, saliva) for research purposes. The purpose of this study is to conduct further analyses on these existing samples from clinical trials that are being performed outside of, but in collaboration with, the National Cancer Institute.

Detailed description

Various human samples (e.g., serum, plasma, whole blood, erythrocytes, urine, feces, bile, and/or saliva) will be collected from cancer patients enrolled on approved clinical trials, in accordance with the local protocol. These trials are being conducted at outside institutions, in collaboration with the National Cancer Institute (NCI) and the samples will be sent to the NCI for pharmacological analysis, involving determination of parent drug and/or metabolite concentrations and subsequent pharmacokinetics and statistical data analysis. This study aims to further characterize the clinical pharmacokinetic behavior of select cancer therapeutics. Future collaborators will be added via the protocol amendment procedure.

Conditions

• Leukemia, Myeloid
• Neoplasm Metastasis
• Leukemia, Lymphoid
• Prostate Cancer

Timeline

• Start date: 2003-07-02
• Primary completion: 2020-03-17
• Completion: 2020-03-26
• First posted: 2006-06-21
• Last updated: 2020-03-30

Locations

17 sites across 2 countries: United States, Netherlands