ThrombocytopeniaNCT04609891
Avatrombopag on the Treatment of Thrombocytopenia Induced by Chemotherapy of Malignant Tumors
A study testing Avatrombopag in people with Thrombocytopenia, run by Anhui Provincial Cancer Hospital at 1 site in China.
Trial summary
To observe the clinical efficacy and safety of avatrombopag for chemotherapy-induced thrombocytopenia in patients with malignant tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- 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
- 74 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2020to 16 May 2021
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18~75 years.
- Diagnosed with malignant tumors (gynecological tumors, gastrointestinal tumors, lung cancer, gastric cancer and head and neck tumors) by pathology or cytology and need chemotherapy.
- The subject had developed at least grade II thrombocytopenia after the last chemotherapy cycle (10×109/L<PLT count<75×109/L).
- Subjects' Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2.
- The subjects' life expectancy at the time of screening is ≥12 weeks, and must continue to receive at least 2 cycles of the same chemotherapy regimen at the time of screening.
- Women of childbearing age must have taken reliable contraceptive measures, or have a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the trial.
- The subjects voluntarily and strictly abide by the requirements of the research protocol and sign a written informed consent.
Who cannot join
- Subjects suffer from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia; according to NYHA standards, grade III to IV cardiac insufficiency, or cardiac color Doppler ultrasound examination suggests left ventricular ejection fraction ( LVEF) <50%.
- Subjects have clinically significant acute or active bleeding (such as gastrointestinal or central nervous system) within 7 days before screening.
- Subjects received major surgery or minor surgery within 4 weeks of enrollment ≤ 3 days.
- Subjects had a history of arterial or venous thrombosis (such as myocardial ischemia, transient ischemic attack, or stroke) within 6 months before screening.
- Subjects had active infection or acute infection occurred within 2 weeks before the first administration of the study.
- Long-term bed rest, subjects with severe vascular disease.
Show all 15Show fewer
- Subjects had a history of chronic thrombocytopenia or bleeding disorders, or a history of thrombocytopenia (such as chronic liver disease or immune thrombocytopenic purpura) caused by causes other than thrombocytopenia caused by chemotherapy.
- Subjects had a history of other malignant tumors, such as acute lymphoblastic leukemia, acute myeloid leukemia, any myeloid malignant tumor, myelodysplastic syndrome, myeloproliferative disease, and multiple myeloma.
- There are factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea, and intestinal obstruction.
- Subjects had an allergic reaction to avatrombopag or any of its excipients.
- Subjects participated in clinical studies of other study drugs or devices within 30 days before screening.
- The investigator assessed that the subjects had any accompanying medical history that could impair the subject's safety in completing the study, such as renal failure due to hemodialysis or active infection requiring intravenous antibiotics.
- Subjects had a history of psychotropic drug abuse and unable to quit or have mental disorders.
- Pregnant or breastfeeding women, and fertile patients who are unwilling or unable to take effective contraceptive measures.
- The investigator judges other conditions that may affect the conduct of clinical research and the determination of research results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-arm, Multi-center, Open Clinical Study of Avatrombopag on the Treatment of Thrombocytopenia Induced by Chemotherapy of Malignant Tumors
To observe the clinical efficacy and safety of avatrombopag for chemotherapy-induced thrombocytopenia in patients with malignant tumors.
Read the detailed description
Tumor is one of the malignant diseases that people face. In 2015, the incidence of malignant tumors was about 3.929 million, and the annual growth rate is about 3.9%. Chemotherapy is currently the most commonly used treatment for patients with tumor, but chemotherapy also brings many other problems, such as thrombocytopenia which can leads to increased medical costs, chemotherapy cycles delayed, and chemotherapy doses reduced. Studies have found that the reduction of the chemotherapy dose and the delay of the chemotherapy cycle will affect the survival rate of patients. So it is an important to solve the problem of chemotherapy-induced thrombocytopenia.
Currently, there are some methods to treat thrombocytopenia such as platelet transfusion, rhTPO, rhIL-11 and other methods. However, these methods have some defects, platelets are at risk of ineffective transfusion, rhTPO may produce neutralizing antibodies and rhIL-11 has serious side effects. Therefore, there is an urgent need for safer and faster methods to treat chemotherapy-induced thrombocytopenia. As a new generation of TPO receptor agonist, avatrombopag has the advantages of being taken with food, no hepatotoxicity, good safety, and rapidly increase platelet count. Therefore, avatrombopag has great research value in the treatment of chemotherapy-induced thrombocytopenia.
- Conditions
- Thrombocytopenia
- Being tested
- Avatrombopag
- Keywords
- chemotherapy, rh-TPO, avatrombopag
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvatrombopagDrug
10×109/L<PLT<75×109/L, avatrombopag tablet 60 mg once a day for 5-10 days.
| Study group | Role | What they receive |
|---|---|---|
| Avatrombopag Tablets Oral | Experimental | When patient is diagnosed with thrombocytopenia induced by chemotherapy of malignant tumor, avatrombopag will be given to patients as a therapeutic plan. Receives: Drug: Avatrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of responders
Proportion of patients with platelet count ≥100×10^9/L or increase of platelet count ≥50×10^9/L or ≥100% from baseline within cycle X after initiation of avatrombopag treatment.Due to chemotherapy induced thrombocytopenia in the X+1 cycle, the dose reduction in chemotherapy of X+2 cycle by ≥15% or chemotherapy delay by ≥4 days.
Measured: up to 2 months
Secondary outcomes (5)
Duration of grade Ⅲ and Ⅳ thrombocytopenia after initiation of avatrombopag treatment
Measured: up to 2 months
Time for PLT to recover to ≥75×10^9/L and ≥100×10^9/L after initiation of avatrombopag treatment
Measured: up to 2 months
minimal platelet count
Measured: up to 2 months
Proportion of patients without platelet transfusion
Measured: up to 2 months
Proportion of patients without bleeding
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start26 May 2020
- Primary completion16 May 2021
- Study completion16 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Liting, Anhui Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609891
- Sponsor's protocol ID
- SKXCIT001
- Status last verified
- Apr 2022
- First submitted
- 4 Oct 2020
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cui Y, He Y, Hu C, Tu C, Huang J, Zhu X, Zang C, Ding K, Zhan B, Zhao Y, Qian L. Avatrombopag for the treatment of thrombocytopenia induced by chemotherapy in patients with solid tumors: A multicenter, open-label, single-arm trial. Front Pharmacol. 2022 Sep 27;13:970978. doi: 10.3389/fphar.2022.970978. eCollection 2022.
PubMed 36238568
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multi-center, Open Clinical Study of Avatrombopag on the Treatment of Thrombocytopenia Induced by Chemotherapy of Malignant Tumors
- ClinicalTrials.gov ID
- NCT04609891
- Acronym / sponsor ID
- SKXCIT001
- Conditions
- Thrombocytopenia
- Keywords
- chemotherapy, rh-TPO, avatrombopag
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Anhui Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 26 May 2020 (actual)
- Primary completion
- 16 May 2021 (actual)
- Study completion
- 16 May 2021 (actual)
- First posted
- 30 Oct 2020 (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.
To observe the clinical efficacy and safety of avatrombopag for chemotherapy-induced thrombocytopenia in patients with malignant tumors.
Detailed description
Tumor is one of the malignant diseases that people face. In 2015, the incidence of malignant tumors was about 3.929 million, and the annual growth rate is about 3.9%. Chemotherapy is currently the most commonly used treatment for patients with tumor, but chemotherapy also brings many other problems, such as thrombocytopenia which can leads to increased medical costs, chemotherapy cycles delayed, and chemotherapy doses reduced. Studies have found that the reduction of the chemotherapy dose and the delay of the chemotherapy cycle will affect the survival rate of patients. So it is an important to solve the problem of chemotherapy-induced thrombocytopenia.
Currently, there are some methods to treat thrombocytopenia such as platelet transfusion, rhTPO, rhIL-11 and other methods. However, these methods have some defects, platelets are at risk of ineffective transfusion, rhTPO may produce neutralizing antibodies and rhIL-11 has serious side effects. Therefore, there is an urgent need for safer and faster methods to treat chemotherapy-induced thrombocytopenia. As a new generation of TPO receptor agonist, avatrombopag has the advantages of being taken with food, no hepatotoxicity, good safety, and rapidly increase platelet count. Therefore, avatrombopag has great research value in the treatment of chemotherapy-induced thrombocytopenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avatrombopag Tablets Oral | Experimental | Drug: AvatrombopagWhen patient is diagnosed with thrombocytopenia induced by chemotherapy of malignant tumor, avatrombopag will be given to patients as a therapeutic plan. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, aged 18~75 years.
- Diagnosed with malignant tumors (gynecological tumors, gastrointestinal tumors, lung cancer, gastric cancer and head and neck tumors) by pathology or cytology and need chemotherapy.
- The subject had developed at least grade II thrombocytopenia after the last chemotherapy cycle (10×109/L<PLT count<75×109/L).
- Subjects' Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2.
- The subjects' life expectancy at the time of screening is ≥12 weeks, and must continue to receive at least 2 cycles of the same chemotherapy regimen at the time of screening.
Key exclusion criteria (15 listed)
- Subjects suffer from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia; according to NYHA standards, grade III to IV cardiac insufficiency, or cardiac color Doppler ultrasound examination suggests left ventricular ejection fraction ( LVEF) <50%.
- Subjects have clinically significant acute or active bleeding (such as gastrointestinal or central nervous system) within 7 days before screening.
- Subjects received major surgery or minor surgery within 4 weeks of enrollment ≤ 3 days.
- Subjects had a history of arterial or venous thrombosis (such as myocardial ischemia, transient ischemic attack, or stroke) within 6 months before screening.
- Subjects had active infection or acute infection occurred within 2 weeks before the first administration of the study.
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 |
|---|---|---|
| Avatrombopag10×109/L<PLT<75×109/L, avatrombopag tablet 60 mg once a day for 5-10 days. | Drug | Avatrombopag Tablets Oral |
Primary outcome
Proportion of responders
Time frame: up to 2 months
Proportion of patients with platelet count ≥100×10^9/L or increase of platelet count ≥50×10^9/L or ≥100% from baseline within cycle X after initiation of avatrombopag treatment.Due to chemotherapy induced thrombocytopenia in the X+1 cycle, the dose reduction in chemotherapy of X+2 cycle by ≥15% or chemotherapy delay by ≥4 days.
5 secondary outcomes
Duration of grade Ⅲ and Ⅳ thrombocytopenia after initiation of avatrombopag treatment
Time frame: up to 2 months
Time for PLT to recover to ≥75×10^9/L and ≥100×10^9/L after initiation of avatrombopag treatment
Time frame: up to 2 months
minimal platelet count
Time frame: up to 2 months
Proportion of patients without platelet transfusion
Time frame: up to 2 months
Proportion of patients without bleeding
Time frame: up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Derived from this study: PubMed 36238568Cui Y, He Y, Hu C, Tu C, Huang J, Zhu X, Zang C, Ding K, Zhan B, Zhao Y, Qian L. Avatrombopag for the treatment of thrombocytopenia induced by chemotherapy in patients with solid tumors: A multicenter, open-label, single-arm trial. Front Pharmacol. 2022 Sep 27;13:970978. doi: 10.3389/fphar.2022.970978. eCollection 2022.
Related trials for Thrombocytopenia
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingPhase 3
rhTPO for Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Procedures.
Thrombocytopenia Associated With Chronic Liver Disease
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)
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 study testing Avatrombopag in people with Thrombocytopenia, run by Anhui Provincial Cancer Hospital at 1 site in China.
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 7 inclusion and 15 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: finished, as of the sponsor's last update on 29 Apr 2022. 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 China. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of responders (time frame: up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04609891, which also lists 1 linked publication.
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 29 Apr 2022.