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Tyrosine Kinase Inhibitor

Pazopanib for Advanced or Refractory Cancer

Phase 1
Waitlist Available
Led By Keith C Bible
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Measurable disease
International normalized ratio (INR) < 1.2 times ULN; (Note: use of warfarin is prohibited; low molecular weight heparin is allowed, so long as these criteria are met)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights

Study Summary

This trial is studying the side effects and best dose of pazopanib hydrochloride for treating patients with solid tumors that have spread or are resistant to treatment. Samples of blood from patients will be studied to learn more about how the drug affects the body and how well patients respond to treatment.

Who is the study for?
This trial is for patients with advanced or treatment-resistant solid tumors. Eligible participants must have normal organ function, measurable disease, no severe heart conditions or blood clots in the past 6 months, and a life expectancy of at least 3 months. They should not be pregnant or nursing and must agree to use contraception.Check my eligibility
What is being tested?
The study is testing Pazopanib Hydrochloride's effectiveness on preventing tumor growth by inhibiting new blood vessel formation. It involves determining the best dose while monitoring side effects and how the body processes the drug through blood sample analysis.See study design
What are the potential side effects?
Potential side effects include high blood pressure, liver issues reflected in altered lab tests, fatigue, diarrhea, nausea, changes in hair color, hypertension and possible risks to heart health such as irregular heartbeat.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer can be measured by tests.
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My blood clotting time is near normal and I'm not on warfarin.
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My blood clotting time is within normal limits and I'm not on warfarin.
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My cancer cannot be treated with surgery or other standard treatments.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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My potassium levels are mostly stable.
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My cancer cannot be cured by standard treatments.
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My calcium levels are mostly normal.
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My cancer can be measured by tests or scans.
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I am fully active or have some restrictions but can still care for myself.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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My magnesium levels are not severely low or high.
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My blood phosphate levels are mostly normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse events profile, as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Biologically optimal dose (BOD) defined as the dose level and diet in combination that induces no toxicity requiring dose modification per protocol and achieves a satisfactory pazopanib trough concentration (Cmin greater than 30 ug/mL)
Incidence of grade 3+ adverse events, as assessed by the NCI CTCAE version 4.0
+7 more
Secondary outcome measures
Pazopanib hydrochloride levels attained in response to standard dosing
Steady state pazopanib hydrochloride trough levels
Trough pazopanib hydrochloride levels

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (pazopanib hydrochloride)Experimental Treatment3 Interventions
Patients receive pazopanib hydrochloride PO 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pazopanib Hydrochloride
2009
Completed Phase 2
~790

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,603 Previous Clinical Trials
40,913,221 Total Patients Enrolled
3 Trials studying Tumors
1,244 Patients Enrolled for Tumors
Keith C BiblePrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
174 Total Patients Enrolled

Media Library

Pazopanib Hydrochloride (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01552356 — Phase 1
Tumors Research Study Groups: Treatment (pazopanib hydrochloride)
Tumors Clinical Trial 2023: Pazopanib Hydrochloride Highlights & Side Effects. Trial Name: NCT01552356 — Phase 1
Pazopanib Hydrochloride (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01552356 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate figure of participants involved in this research endeavor?

"Unfortunately, this trial is not enrolling participants at the moment. The clinical trial was first posted on March 19th 2012 and last updated June 28th 2022. Fortunately, there are currently 17 studies actively admitting patients with solid neoplasms as well as 24 trials for Pharmacological Study that have open enrollment periods."

Answered by AI

What other laboratory experiments have explored the efficacy of pharmacological treatments?

"Initially conducted at the University of Texas MD Anderson Cancer Center in 2011, the Pharmacological Study has now seen 750 successful trials. Currently there are 24 enrolment sites across Rochester, Minnesota that are actively recruiting participants for new research studies."

Answered by AI

Is this medical experiment enrolling participants at present?

"Unfortunately, the recruitment period for this clinical trial has ended. Initially posted on March 19th 2012 and most recently amended on June 28th 2022, there are no further openings available. However, if you are seeking alternative studies to join there are presently 17 trials searching for participants with solid neoplasms and 24 Pharmacological Study trials actively recruiting patients."

Answered by AI

Has Pharmacological Study been approved by the FDA?

"Given that this is a Phase 1 trial, meaning there are only limited data supporting efficacy and safety of the pharmacological study, our team at Power has assigned it a score of 1."

Answered by AI

Is this a groundbreaking research endeavor?

"Pharmacological Study has been under examination since 2011, when Novartis sponsored its first trial with 180 participants. After achieving Phase 2 drug approval in the years following, 24 active studies have now taken form across 608 cities and 23 countries."

Answered by AI
~4 spots leftby Mar 2025