ThrombocytopeniaEarly Phase 1NCT04931849
Study of Avatrombopag for Temozolomide-induced Thrombocytopenia in Glioma (APATIT-G)
A Early Phase 1 study testing Avatrombopag in people with Thrombocytopenia, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to determine if using avatrombopag in patients with thrombocytopenia due to temozolomide treatment can safely improve a patient's platelet count and allow the patient to complete the temozolomide treatment course as planned. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia
- What is being tested?
- Avatrombopag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2022to 18 Jul 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological confirmation of grade 2, 3 or 4 glioma
- Subject has initiated concurrent RT and temozolomide followed by planned 6-12 cycles of temozolomide;
- Subject is willing and able to provide written informed consent;
- Subject is ≥ 18 years of age at the time of informed consent;
- Subject is willing and able to comply with all aspects of the protocol;
- Subject had platelet counts ≥ 100, 000/uL at the start of RT+TMZ or TMZ alone;
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- Subject experienced grade ≥ 3 (moderate to severe) thrombocytopenia, defined by platelet counts ≤ 50 x 109/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;
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
- Subject has a life expectancy > 12 weeks at screening and is able to receive at least 2 additional cycles of TMZ;
- Females of childbearing potential must agree to use a highly effective method of contraception (combination of condom, diaphragm, or sponge with a spermicide) throughout the entire study period and for 28 days after the investigational product (IP) discontinuation;
Who cannot join
- History of hematologic malignancy, including leukemia, myeloma, myeloproliferative disease, lymphoma, or myelodysplastic syndrome;
- Subject with history of solid tumor and has received chemotherapy alone or chemotherapy and radiation in the past 5 years;
- Subject has received > 2 previous lines of chemotherapy;
- Subjects who have previously received radiation treatments to the pelvic region including brachytherapy;
- Subject with an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 x upper limit of normal (ULN) or total bilirubin ≥ 3 x upper limit of normal;
- Subject is known to be human immunodeficiency virus positive;
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- Known clinically significant acute or active bleeding (e.g., gastrointestinal or central nervous system) within 7 days of screening;
- 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);
- Subject has a medical condition that, in the opinion of the investigator, would compromise the subject's ability to safely complete the study, such as unstable angina, renal failure requiring dialysis, or active infection requiring intravenous antibiotics;
- History of arterial or venous thrombosis within 6 months of screening;
- Subject has used vitamin K antagonist within 7 days of screening (use of low molecular weight heparin, factor Xa inhibitors, or direct thrombin inhibitors is allowed);
- Subject has a history of chronic platelet or bleeding disorder or thrombocytopenia due to another etiology other than temozolomide (e.g., chronic liver disease or immune thrombocytopenia purpura);
- Subject has used moderate or strong dual inducer of cytochrome P450 (CYP) 2C9 or CYP3A4/5 such as rifampin within 7 days of screening, and/or moderate or strong dual inhibitor such as fluconazole;
- Subject has previously received a thrombopoietin receptor agonist (e.g., eltrombopag or romiplostim) for the treatment of temozolomide induced thrombocytopenia;
- Subject has received a platelet transfusion within 3 days of screening;
- Subject is unable to take oral medication;
- Female subjects who are lactating or pregnant at screening (as documented by positive serum beta-human chorionic gonadotropin [β-hCG] test) or the baseline visit (serum pregnancy test);
- For all men and women of childbearing potential: Refusal or inability to use effective means of contraception;
- History of significant cardiovascular disease or arrhythmia known to increase the risk of thromboembolic events such as atrial fibrillation, coronary artery stent placement, angioplasty, or coronary artery bypass graft) within 6 months of screening;
- Subject is currently enrolled in another clinical study with any investigational drug or device within 30 days of screening; however, participation in observational studies is permitted;
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: A Pilot Study of Avatrombopag for Temozolomide-induced Thrombocytopenia in Glioma (APATIT-G)
The purpose of this study is to determine if using avatrombopag in patients with thrombocytopenia due to temozolomide treatment can safely improve a patient's platelet count and allow the patient to complete the temozolomide treatment course as planned.
Read the detailed description
The purpose of this study is to determine if using avatrombopag in patients with low platelet count due to temozolomide treatment is safe, while at the same time assess whether the avatrombopag can improve the low platelet count and allow the temozolomide treatment to continue as planned.
- Conditions
- Thrombocytopenia
- Being tested
- Avatrombopag
- Keywords
- Thrombocytopenia, Temozolomide, Avatrombopag, Temozolomide-induced Thrombocytopenia
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvatrombopagDrug
Avatrombopag is a small molecule thrombopoeitic receptor agonist (TPO-RA) that mimics the biological effects of thrombopoeitin (TPO)
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Avatrombopag | Experimental | Avatrombopag 40 mg daily by mouth (PO) Receives: Drug: Avatrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of treatment
Measure of time from study enrollment until progression.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start6 May 2022
- Primary completion11 Oct 2023
- Study completion18 Jul 2024 (estimated)
Why it stopped: PI and Sponsor decided to not proceed with the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Akwaa, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931849
- Sponsor's protocol ID
- UCCS20154
- Status last verified
- Jan 2025
- First submitted
- 11 Jun 2021
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Avatrombopag for Temozolomide-induced Thrombocytopenia in Glioma (APATIT-G)
- ClinicalTrials.gov ID
- NCT04931849
- Acronym / sponsor ID
- UCCS20154
- Conditions
- Thrombocytopenia
- Keywords
- Thrombocytopenia, Temozolomide, Avatrombopag, Temozolomide-induced Thrombocytopenia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI and Sponsor decided to not proceed with the trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 6 May 2022 (actual)
- Primary completion
- 11 Oct 2023 (actual)
- Study completion
- 18 Jul 2024 (estimated)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if using avatrombopag in patients with thrombocytopenia due to temozolomide treatment can safely improve a patient's platelet count and allow the patient to complete the temozolomide treatment course as planned.
Detailed description
The purpose of this study is to determine if using avatrombopag in patients with low platelet count due to temozolomide treatment is safe, while at the same time assess whether the avatrombopag can improve the low platelet count and allow the temozolomide treatment to continue as planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Avatrombopag | Experimental | Drug: AvatrombopagAvatrombopag 40 mg daily by mouth (PO) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histological confirmation of grade 2, 3 or 4 glioma
- Subject has initiated concurrent RT and temozolomide followed by planned 6-12 cycles of temozolomide;
- Subject is willing and able to provide written informed consent;
- Subject is ≥ 18 years of age at the time of informed consent;
- Subject is willing and able to comply with all aspects of the protocol;
Key exclusion criteria (21 listed)
- History of hematologic malignancy, including leukemia, myeloma, myeloproliferative disease, lymphoma, or myelodysplastic syndrome;
- Subject with history of solid tumor and has received chemotherapy alone or chemotherapy and radiation in the past 5 years;
- Subject has received > 2 previous lines of chemotherapy;
- Subjects who have previously received radiation treatments to the pelvic region including brachytherapy;
- Subject with an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 x upper limit of normal (ULN) or total bilirubin ≥ 3 x upper limit of normal;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvatrombopagAvatrombopag is a small molecule thrombopoeitic receptor agonist (TPO-RA) that mimics the biological effects of thrombopoeitin (TPO) | Drug | Experimental: Avatrombopag |
Primary outcome
Safety of treatment
Time frame: 48 weeks
Measure of time from study enrollment until progression.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Avatrombopag in people with Thrombocytopenia, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of treatment (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.