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


Phase 1
N/A
N/A
Open (Enrolling by invite only)
Both
Pharmacokinetics

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Trial Information

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


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.

Inclusion Criteria


- INCLUSION CRITERIA:

Any patients entered on approved trials of cancer therapeutics or agents that are commonly
administered to patients with cancer at institutions outside of the intramural NCI are
eligible for inclusion, provided that they have consented to pharmacological analysis in
the original consent form.

EXCLUSION CRITERIA:

None anticipated at this time.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

William D Figg, Pharm.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

999903242

NCT ID:

NCT00339664

Start Date:

June 2003

Completion Date:

Related Keywords:

  • Pharmacokinetics
  • Pharmacokinetics
  • Quantify
  • HPLC
  • LC/MS
  • Pharmacodynamics

Name

Location

Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Case Western Reserve UniversityCleveland, Ohio  44106
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
University of ChicagoChicago, Illinois  60637
Johns Hopkins Medical CenterBaltimore, Maryland  
Sidney Kimmel Comprehensive Cancer CenterLutherville, Maryland  
Mayo Clinic, RochesterRochester, Minnesota  55905
University of Maryland, BaltimoreBaltimore, Maryland  21201-1595
University of Maryland at Amish Research Clinic, LancasterLancaster, Pennsylvania  
Abramson Cancer Center, University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Hillman Cancer Center at University of Pittsburg Cancer InstitutePittsburg, Pennsylvania  15261
Massey Cancer Center, Virginia Commonwealth UniversityRichmond, Virginia  23298
McGuire Veterans Administration Medical CenterRichmond, Virginia  23249