Pazopanib Hydrochloride in Treating Patients With Advanced or Refractory Solid Tumors

Solid Neoplasm Clinical Trial

Official title: Pharmacokinetic-Driven Individualization of Pazopanib Therapy in Patients With Solid Tumors: A Phase I Study

Status Active, not recruiting

Clinical Trial Summary

This phase I trial studies the side effects and the best dose of pazopanib hydrochloride in treating patients with solid tumors that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or does not respond to treatment (refractory). Pazopanib hydrochloride may prevent the growth of new blood vessels that tumors need to grow. Studying samples of blood in the laboratory from patients receiving pazopanib hydrochloride may help doctors learn more about the effects of the body on the drug. It may also help doctors understand how well patients respond to treatment.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To assess the feasibility and safety of individualizing pazopanib (pazopanib hydrochloride) monotherapy based upon attained pazopanib plasma concentrations so as to achieve desired target pazopanib plasma concentration in the highest possible fraction of treated patients.

SECONDARY OBJECTIVES:

I. To assess whether patient cytochrome P450 (CYP) or other polymorphisms may correlate with attained pazopanib levels in response to standard pazopanib dosing.

II. To assess whether patient trough pazopanib levels attained 24 hours after initiation of 800 mg daily fasting may predict steady state trough pazopanib levels after 14 days of pazopanib administration.

III. To assess whether patient trough pazopanib levels may correlate with observed pazopanib toxicities.

OUTLINE: This is a dose-escalation study.

Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Course length can be extended to 56 days at the discretion of the treating physician after 12 courses (1 year) of treatment on study.

After completion of study treatment, patients are followed up for 3 months. ;

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Neoplasm

• NCT number: NCT02706366
• Study type: Interventional
• Source: Mayo Clinic
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 2012