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Tyrosine Kinase Inhibitor

Pazopanib for Hereditary Hemorrhagic Telangiectasia (Paz Trial)

Phase 2 & 3
Recruiting
Led By James Gossage, MD
Research Sponsored by Cure HHT
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up epistaxis severity - average of last 6 weeks of study compared to baseline 6 weeks; change in ess at 12, 24 and 48 weeks (versus baseline)

Summary

This trial will test if Pazopanib, taken daily for 24 weeks, can reduce nose bleed severity and duration in HHT patients. Tests will also measure blood loss and safety.

Who is the study for?
This trial is for individuals with hereditary hemorrhagic telangiectasia (HHT) who experience severe nosebleeds and anemia. Participants must be able to monitor their blood pressure at home, not start new HHT therapies during the study, and women of childbearing age must use effective contraception. People with certain medical conditions or on prohibited medications cannot join.
What is being tested?
The trial tests if Pazopanib can reduce nosebleed severity in HHT patients over a 24-week period compared to a placebo. It also monitors blood loss and safety. Patients will take the drug daily and have regular check-ups to assess the impact on their condition.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with Pazopanib may include high blood pressure, diarrhea, hair color changes, nausea, weight loss, fatigue, and liver issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~epistaxis severity - average of last 6 weeks of study compared to baseline 6 weeks; change in ess at 12, 24 and 48 weeks (versus baseline)
This trial's timeline: 3 weeks for screening, Varies for treatment, and epistaxis severity - average of last 6 weeks of study compared to baseline 6 weeks; change in ess at 12, 24 and 48 weeks (versus baseline) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in epistaxis duration in minutes
Hemoglobin Response rate increase in hemoglobin
Secondary study objectives
Achievement of meaningful improvement in epistaxis for HHT patients
Assess pharmacokinetics and pharmacodynamics (PK/PD) of treatment
Assess the safety of up to 24 and 48 weeks of treatment of pazopanib
+2 more
Other study objectives
Assess effect of up to 24 and 48 weeks of pazopanib treatment on level of epistaxis severity
Assess effects of up to 24 weeks of pazopanib treatment on epistaxis duration
Assess effects of up to 24 weeks of pazopanib treatment on epistaxis symptom elements
+10 more

Side effects data

From 2019 Phase 2 trial • 30 Patients • NCT01466972
53%
Fatigue
50%
Nausea
37%
Diarrhea
33%
Back pain
30%
Hypertension
30%
Anorexia
23%
Abdominal pain
20%
Bone pain
17%
Dyspnea
17%
Vomiting
17%
Headache
17%
Aspartate aminotransferase increased
13%
Arthralgia
13%
Constipation
13%
Palmar-plantar erythrodysesthesia syndrome
13%
Alanine aminotransferase increased
13%
Investigations - Other
10%
Anemia
10%
Blurred vision
10%
Chills
10%
Pain in extremity
10%
Hot flashes
10%
Dysgeusia
10%
Rash maculo-papular
10%
Alkaline phosphatase increased
7%
White blood cell decreased
7%
Platelet count decreased
7%
Neutrophil count decreased
7%
Urinary frequency
7%
Urinary incontinence
7%
Alopecia
7%
Dry Mouth
7%
Skin and subcutaneous tissue disorders - Other
7%
Cough
7%
Urinary tract pain
7%
Gastroesophageal reflux disease
7%
Fever
7%
Dyspepsia
7%
Non-cardiac chest pain
7%
Hypothyroidism
7%
Hyperglycemia
7%
Hyponatremia
7%
Peripheral motor neuropathy
7%
Blood bilirubin increased
3%
Pleural effusion
3%
Hypotension
3%
Back Pain
3%
Thromboembolic event
3%
Heart Failure
3%
Small intestinal obstruction
3%
Vertigo
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pazopanib in Combination With a NSAI

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Part C Pazopanib - 150 mgExperimental Treatment1 Intervention
Pazopanib 150 mg oral daily dosing (six 25 mg Pazopanib capsules).
Group II: Part B (Severe Anemia) Pazopanib - 150 mgActive Control1 Intervention
150 mg pazopanib oral capsules (six 25 mg placebo capsules daily).
Group III: Part B (Severe Epistaxis) Pazopanib - 150 mgActive Control1 Intervention
Pazopanib 150 mg oral daily dosing (six 25 mg Pazopanib capsules).
Group IV: Part B (Severe Expistaxis) PlaceboPlacebo Group1 Intervention
Placebo oral capsules (six 25 mg placebo capsules daily).
Group V: Part B (Severe Anemia) PlaceboPlacebo Group1 Intervention
Placebo oral capsules (six 25 mg placebo capsules daily).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pazopanib
2012
Completed Phase 4
~1370

Find a Location

Who is running the clinical trial?

Food and Drug Administration (FDA)FED
181 Previous Clinical Trials
1,548,708 Total Patients Enrolled
Cure HHTLead Sponsor
3 Previous Clinical Trials
10,317 Total Patients Enrolled
United States Department of DefenseFED
908 Previous Clinical Trials
333,610 Total Patients Enrolled

Media Library

Pazopanib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03850964 — Phase 2 & 3
Nosebleed Research Study Groups: Part B (Severe Anemia) Pazopanib - 150 mg, Part B (Severe Epistaxis) Pazopanib - 150 mg, Part B (Severe Expistaxis) Placebo, Part B (Severe Anemia) Placebo, Part C Pazopanib - 150 mg
Nosebleed Clinical Trial 2023: Pazopanib Highlights & Side Effects. Trial Name: NCT03850964 — Phase 2 & 3
Pazopanib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03850964 — Phase 2 & 3
~22 spots leftby Jul 2025
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