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Effect of Ketoconazole Administration on the Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Tumors

Thank you

Trial Information

Effect of Ketoconazole Administration on the Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients With Advanced Solid Tumors


Inclusion Criteria:



- Male and female patients 18 years of age or older, with a diagnosis of advanced solid
tumor for which no curative or other treatment of higher priority is available

- Karnofsky Performance Status (KPS) equal to or greater than 70%

- Normal liver function tests (aspartate transaminase [AST] or alanine transaminase
[ALT] equal to or less than 2 x upper limit of normal [ULN])

- Total bilirubin equal to or less than 1.5 x ULN

- Calculated creatinine clearance equal to or greater than 50 mL/min

- Normal serum calcium

Exclusion Criteria:

- Patients with significant cardiac disease

- Equal to or greater than Grade 2 neuropathy

- Active hepatitis

- HIV infection

- Secondary malignancy

- Transfusion-dependent or received extensive radiation therapy, systemic chemotherapy,
or other antineoplastic therapy within 4 weeks of enrollment

- Patients taking concomitant medications having inhibitory or inducing activity for
CYP 3A4

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

M34103-059

NCT ID:

NCT00129207

Start Date:

Completion Date:

Related Keywords:

  • Tumors
  • pharmacokinetic
  • pharmacodynamics
  • VELCADE
  • Ketoconazole
  • CYP 3A4
  • Solid Tumor
  • Advanced Solid Tumors

Name

Location

Medical Center, UPMC Cancer PavilionPittsburgh, Pennsylvania  15232