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Pazopanib to Treat Adults With Advanced Cancers and Varying Degrees of Liver Function

NCT00674024 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-11-20

No results posted yet for this study

Summary

Background:

* Pazopanib is an experimental drug that was designed to enter cancer cells and block the activity of proteins that are important for cancer cell growth and survival.
* This is the first study in which pazopanib is given to patients with different degrees of liver function. The safe dose for patients with normal liver function is already known.

Objectives:

* To determine the safety and side effects of pazopanib given at different dose levels to patients with cancer who have different degrees of liver function.
* To find out how much pazopanib is in the blood at specific times.
* To determine if pazopanib is effective in treating advanced cancer in patients with different degrees of liver function.

Eligibility:

\- Patients 18 years of age and older with an advanced solid tumor or lymphoma that cannot be treated successfully with standard therapies and who have normal or abnormal liver function.

Design:

* Treatment:
* Patients are divided into 4 groups, based on their liver function. The first three patients in each group receive a low dose of pazopanib. The next three in each group receive a higher dose of pazopanib if no serious side effects were reported in the previous three. The dose is increased in succeeding groups of three patients until the maximum study dose is reached.
* Patients take pazopanib once a day by mouth in 21-day treatment cycles. Treatment continues until the cancer worsens, the patient develops severe side effects, the patient no longer wants to continue the study, or the doctor removes the patient from the study for other reasons.
* Monitoring:
* Blood pressure: Patients monitor and record their blood pressure twice a day after starting treatment.
* Blood tests: Patients have weekly routine blood tests. In addition, at week 3 of the first cycle and again after the highest safe dose has been determined, several blood samples are collected at frequent intervals to determine how the body handles the drug.
* Imaging studies: X-rays or scans or both are done to measure the extent of disease every 3 cycles.
* Physical examinations are done at periodic intervals.

Conditions

Interventions

DRUG

Pazopanib

DRUG

Pazopanib (GW786034)(GW786034)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Shivaani Kummar, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-07
Primary Completion
2013-01-22
Completion
2013-01-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00674024 on ClinicalTrials.gov