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Avatrombopag for Low Platelet Count

Phase < 1
Recruiting
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject experienced grade ≥ 3 (moderate to severe) thrombocytopenia, defined by platelet counts ≤ 50 x 10^9/L, measured at least 24 hours apart, during the induction RT+TMZ, or at any time during the maintenance TMZ
Subject is able to continue to receive temozolomide regimen at the standard maintenance dose and schedule
Must not have
Subject is unable to take oral medication
Known history of thrombophilia with high risk of thrombosis (e.g., homozygous factor V Leiden mutation or prothrombin G20210A mutation, anti-thrombin deficiency, protein C deficiency, protein S deficiency, or antiphospholipid antibody syndrome)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a medication can safely help thrombocytopenia patients finish their temozolomide cancer treatment.

Who is the study for?
This trial is for adults with grade 2-4 glioma who have low platelet counts due to temozolomide treatment. They must be able to take oral medication, not have had certain cancers or treatments in the past 5 years, and agree to use effective contraception. People with significant heart disease, recent thrombosis, or other serious health issues are excluded.
What is being tested?
The study tests if avatrombopag can safely raise platelet counts in patients whose levels dropped because of temozolomide therapy for glioma. The goal is to help them continue their cancer treatment without interruption.
What are the potential side effects?
Potential side effects of avatrombopag may include risks of blood clots, liver enzyme changes, and possible reactions at the site where the drug is taken. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had severe low platelet counts twice, 24 hours apart, during my cancer treatment.
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I can continue taking temozolomide at the standard dose and schedule.
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I am 18 years old or older.
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I am expected to live more than 12 weeks and can receive at least 2 more TMZ treatments.
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My brain tumor is confirmed to be grade 2, 3, or 4.
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I am currently undergoing radiation therapy and temozolomide treatment, with plans for 6-12 cycles of temozolomide.
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I can take care of myself and am up and about more than half of my waking hours.
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I agree to use effective birth control during and for 28 days after the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot take medicine by mouth.
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I have a genetic condition that increases my risk of blood clots.
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I had a solid tumor and was treated with chemotherapy, with or without radiation, in the last 5 years.
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I have had radiation therapy to my pelvic area before.
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I am not pregnant or breastfeeding.
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I haven't had any serious bleeding episodes in the last week.
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I have a history of blood cancer.
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I have a long-term bleeding or platelet disorder not caused by temozolomide.
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I have undergone more than two chemotherapy treatments.
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I have had serious heart issues or procedures in the last 6 months.
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I have been treated with drugs like eltrombopag or romiplostim for low platelet counts caused by temozolomide.
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I have not taken drugs like rifampin or fluconazole in the last week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety of treatment

Side effects data

From 2014 Phase 3 trial • 49 Patients • NCT01438840
38%
Headache
31%
Contusion
19%
Upper respiratory tract infection
13%
Gingival bleeding
13%
Arthralgia
13%
Fatigue
13%
Epistaxis
13%
Petechiae
9%
Nasopharyngitis
9%
Insomnia
9%
Mouth Haemorrhage
9%
Nausea
9%
Back pain
6%
Anaemia
6%
Influenza
6%
Thrombocytopenia
6%
Vomiting
6%
Blood gastrin increased
6%
Cough
6%
Hypertension
3%
Dyspepsia
3%
Cerebrovascular accident
3%
Mouth haemorrhage
3%
Food poisoning
3%
Polyserositis
3%
Uterine haemorrhage
3%
Urinary tract infection
3%
Platelet count decreased
3%
Deep vein thrombosis
3%
Pain in extremity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avatrombopag (Core Study)
Avatrombopag (Extension Phase)
Placebo (Core Study)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental: AvatrombopagExperimental Treatment1 Intervention
Avatrombopag 40 mg daily by mouth (PO)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avatrombopag
2016
Completed Phase 3
~490

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
871 Previous Clinical Trials
549,794 Total Patients Enrolled

Media Library

Avatrombopag Clinical Trial Eligibility Overview. Trial Name: NCT04931849 — Phase < 1
Low Platelet Count Research Study Groups: Experimental: Avatrombopag
Low Platelet Count Clinical Trial 2023: Avatrombopag Highlights & Side Effects. Trial Name: NCT04931849 — Phase < 1
Avatrombopag 2023 Treatment Timeline for Medical Study. Trial Name: NCT04931849 — Phase < 1
~7 spots leftby Dec 2025
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