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Cytarabine

No intervention aiming at preventing thrombocytopenia will be taken after first cycle. Avatrombopag as salvage treatment will be administered to patients suffering from thrombocytopenia with nadir platelet count \< 50 × 109/L at a dose of 60mg/day until there is drug-withdrawal indication.

As the primary prevention of thrombocytopenia induced by cytarabine-based chemotherapy, Avatrombopag will be administered at a dose of 60mg/day on days -3\~-1 and 3\~9, for a total of 10 doses. On the condition that patients have platelet counts \<50 × 10 9 /L before next cycle, Avatrombopag will be administered at a dose of 60mg/day until there is drug-withdrawal indications. Platelet transfusions were administered to patients when the platelet count was less than 10×109 /L.

Drug-withdrawal indications:

PLT ≥ 100×109/L during salvage treatment or platelet count increases by 50×109/L, comparing with baseline level.

When platelet count is higher than 400×109/L during this study, researchers determine whether avatrombopag is discontinued

avatrombopag

Qingqing Cai, MD

This phase 2 trial studies the efficacy and safety of Avatrombopag for the primary prevention of thrombocytopenia induced by cytarabine-based chemotherapy in patients with lymphoma

Avatrombopag for the Primary Prevention of Thrombocytopenia Induced by Cytarabine-based Chemotherapy in Patients With Lymphoma

Avatrombopag for the Primary Prevention of Thrombocytopenia Induced by Cytarabine-based Chemotherapy in Patients With Lymphoma: An Open, Single-center, Phase II Randomized Controlled Clinical Study

Sun Yat-sen University

Chief physician

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

The baseline platelet count before enrollment was \< 75×10\^9/L and \> 30×10\^9/L.The primary clinical diagnosis of hepatocellular carcinoma was confirmed, and the CNLC stages were Ia and Ib.An elective hepatectomy, including laparotomy or laparoscopic hepatectomy, except hepatectomy combined with splenectomy or radiofrequency ablation.

On the basis of conventional treatment, Avatrombopag was added, 30×10\^9/L \< platelet count \< 50×10\^9/L patients received Avatrombopag 60mg/d, 50×10\^9/L≤ platelet count \< 75×10\^9/L patients received Avatrombopag 40mg/d for 5 consecutive days, and waited for a period of time after drug withdrawal.Surgery is expected to take place on day 10-13 of the initial dose.

Avatrombopag

Jian Zhou, MD PhD

Hepatocellular carcinoma (HCC) is one of the most common malignant tumors in the world, accounting for the second leading cause of cancer death in China.Surgical treatment of hepatocellular carcinoma is the most important means for long-term survival of patients with hepatocellular carcinoma, including hepatectomy and liver transplantation.Chronic liver disease caused by hepatitis B infection is the main pathogenic factor of liver cancer in China. Meanwhile, nearly 80% of patients with hepatocellular carcinoma are complicated with cirrhosis, and the incidence of thrombocytopenia in patients with cirrhosis is reported to be as high as 78%.Many previous studies have found that thrombocytopenia is closely related to perioperative outcome of hepatocellular carcinoma.The purpose of this study was to evaluate the efficacy and safety of avatripopa in the treatment of thrombocytopenia in patients with primary hepatocellular carcinoma undergoing elective hepatectomy and its effect on perioperative outcome.

The indicators included changes in platelet count before and after drug treatment and operation, the nature and amount of postoperative drainage (ascites), duration of indwelling drainage tube, intraoperative blood loss, perioperative complications, length of hospital stay, etc.After comprehensive consideration of all perioperative indicators, we selected the total amount of drainage (ascites) multiple days after surgery as the primary outcome.

Treatment of Avatrombopag for Thrombocytopenia in Patients Undergoing Selective Resection of Hepatocellular Carcinoma

Efficacy and Safety of Avatrombopag in Thrombocytopenia in Patients With Primary Hepatocellular Carcinoma Undergoing Elective Hepatectomy: a Multicenter, Randomized, Controlled Study

The Percentage of patients in the treatment group with platelet count ≥75×10\^9/L (the highest test value of of platelet count was taken on day 9-12 of treatment) and an increase of platelet count more than 20% from baseline before operation.

Comparison of total amount of postoperative drainage fluid on day 1, 3 and 5 after surgery between treatment group and control group

Comparison of intraoperative blood loss between Treatment group and control group.

Comparison of the proportion of patients receiving remedial treatment due to bleeding risk after surgery between the treatment group and the control group

Comparison of postoperative indwelling time of drainage tube between treatment group and control group

Comparison of red blood cell count and hemoglobin content of drainage fluid between treatment group and control group on the 1st, 3rd and 5th day after operation

Comparison of postoperative hospitalization time between treatment group and control group

Preoperative platelet count increase from baseline in treatment group.

The change of platelet count from baseline at different time points in the treatment group.

Shanghai Zhongshan Hospital

Maleic acid

Enzyme Inhibitors

30 participants will be randomized into a 1:1 fashion and will be stratified based on the number of cytotoxic agents in the patient's chemotherapy regimen. Participants will complete study procedures as outlined:

Lead-In Period (Day 1 - 15)

* Pre-determined dose of Avatrombopag 1x daily.
* Participants failing to achieve a platelet count ≥100,000/µL within 2 weeks will be considered a treatment failure (and will proceed to the end-of-study visit).

On-Cycle Period (Day 15 - up to Week 6)

• Pre-determined dose of Avatrombopag 1x daily.

Follow-up Period

* End of Treatment on-site visit.
* Follow-up visit 30-42 days after End of Treatment visit.

30 participants will be randomized into a 1:1 fashion and will be stratified based on the number of cytotoxic agents in the patient's chemotherapy regimen. Participants will complete study procedures as outlined:

Lead-In Period (Day 1 - 15)

* Pre-determined dose of matching placebo 1x daily.
* Participants failing to achieve a platelet count ≥100,000/µL within 2 weeks will be considered a treatment failure (and will proceed to the end-of-study visit).

On-Cycle Period (Day 15 - up to Week 6)

• Pre-determined dose of matching placebo 1x daily.

Follow-up Period

* End of Treatment on-site visit.
* Follow-up visit 30-42 days after End of Treatment visit.

Thrombopoietin receptor agonist, tablet taken orally.

Lactose monohydrate, tablet taken orally.

Matching Placebo

Hanny Al-Samkari, MD

Gerald Soff, MD

Stephen Lattanzi, M.D.

Gerald A Soff, MD

Kanika Nair, M.D.

Joseph Shatzel, M.D.

Sandhya Panch, M.D.

The purpose of this study is to compare the efficacy of two study drugs, Avatrobopag versus placebo, to treat persistent Chemotherapy-Induced Thrombocytopenia (CIT) in patients with gastrointestinal (GI) malignancies receiving cytotoxic chemotherapy.

The names of the study drugs involved in this study are:

* Avatrombopag (a thrombopoietin receptor agonist)
* Matching placebo

This is a randomized, double-blinded, placebo-controlled, multicenter phase 2 clinical trial evaluating Avatrombopag versus placebo for Chemotherapy-Induced Thrombocytopenia (CIT) in patients with gastrointestinal (GI) malignancies. Avatrombopag may increase or stimulate megakaryocytes, which aid in producing blood platelets, resulting in an increased production of platelets.

* Participants will be "randomized" into one of the study groups: Group A: Avatrombopag or Group B: Matching placebo. Randomization means that a participant is put into a group by chance.
* All patients who complete the study (whether they received avatrombopag or placebo) have the opportunity to receive avatrombopag to treat CIT through a special free drug program available only to the participants of this study.

The U.S. Food and Drug Administration (FDA) has not approved avatrombopag for CIT, but it has been approved for other uses.

Study procedures include screening for eligibility, treatment visits, and blood tests.

Participants will receive the study treatment or placebo for up to seven weeks and will be followed for up to 42 days after the last dose.

It is expected that about 60 people will take part in this research study.

Swedish Orphan Biovitrum (Sobi), biopharmaceutical company, is supporting this research study by providing the study drugs and funding.

Avatrombopag vs. Placebo for CIT in GI Malignancies

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Avatrombopag for Persistent Chemotherapy-Induced Thrombocytopenia in Patients With Gastrointestinal Malignancies (ACT-GI)

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

The primary endpoint of this study is the comparison of the response rate between the avatrombopag arm and the placebo arm. A response is defined as achieving a platelet count ≥100,000/µL within the 2 week lead-in period and then finishing at least 1 cycle of chemotherapy without CIT recurrence (no on-cycle dose-reduction or treatment delay due to thrombocytopenia and ability to receive another cycle of chemotherapy without dose-reduction or treatment delay, defined as platelet count of ≥100,000/µL at the start of the following cycle whether or not an additional cycle is planned).

Defined as the composite of successful initial platelet count recovery to ≥100,000/µL within 15 days of initiation of study drug, plus CIT prevention for one additional chemotherapy cycle (including at the completion of that cycle/start of the following cycle).

Assessed by the rate of initial platelet count recovery to ≥100,000/µL during the lead-in period

Assessed by the rate of initial platelet count recovery to ≥100,000/µL during the lead-in period.

The decision on platelet transfusion could be made either because the patient's platelet count is below a threshold, or due to physician's decision. The probability of patients requiring platelet transfusion will be estimated with a 95% confidence interval.

The rate of clinically relevant bleeding will be estimated by the Kaplan-Meier curve. Bleeding events will be graded according to CTCAE and according to the modified WHO bleeding scale. Clinically significant bleeding events will be considered grade II-IV events per this scale.

Thromboembolic events will be graded per CTCAE.

Swedish Orphan Biovitrum

Principal Investigator

Chlorotrianisene

Patients receive avatrombopag treatment 5-10 days.

Avatrombopag (platelet count \[PLT\] \<40×10\^9/L, 60mg P.O. QD; PLT of 40-75×10\^9/L, 40mg P.O. QD) will be administered to the patients and last 5-10 days. When the PLT reaches ≥100×10\^9/L, the treatment will be discontinued.

Mingyue Cai, Dr.

Kangshun Zhu, Dr.

This study is conducted to evaluate the efficacy of avatrombopag for thrombocytopenia in patients with hepatocellular carcinoma (HCC) who intend to undergo transarterial chemoembolization (TACE) and/or hepatic arterial infusion chemotherapy (HAIC).

This is a single-center, prospective study to evaluate the efficacy of avatrombopag for thrombocytopenia in HCC patients who intend to undergo TACE and/or HAIC.

30 HCC patients with thrombocytopenia will be enrolled in this study. Avatrombopag (platelet count \[PLT\] \<40×10\^9/L, 60mg P.O. QD; PLT of 40-75×10\^9/L, 40mg P.O. QD) will be administered to the patients and last 5-10 days. When the PLT reaches ≥100×10\^9/L, the treatment will be discontinued.

The primary end point of this study is the proportion of patients with PLT \>75×10\^9/L or doubling from baseline. The secondary endpoints are the proportion of patients with PLT \>75×10\^9/L, the proportion of patients with PLT doubling from baseline, the increace in PLT, the proportion of patients who successfully receive TACE/HAIC, .adverse events.

Avatrombopag for HCC Patients With Thrombocytopenia Who Intend to Undergo TACE and/or HAIC

A Single-center, Single-arm Study of Avatrombopag for Patients With Hepatocellular Carcinoma and Thrombocytopenia Who Intend to Undergo Transarterial Chemoembolization and/or Hepatic Arterial Infusion Chemotherapy

The proportion of patients with PLT \>75×10\^9/L or doubling from baseline

The proportion of patients with PLT \>75×10\^9/L

The proportion of patients with PLT doubling from baseline

The proportion of patients who successfully receive TACE/HAIC

Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0.

Second Affiliated Hospital of Guangzhou Medical University

Central Nervous System Depressants

Other Dietary Supplements

Benzocaine

Tannic Acid

50 enrolled subjects will be picked up to take Avatrombopag at the indicated dose.

The subjects will initiate treatment with 60 mg/d Avatrombopag. Platelet counts is obtained weekly and dose adjustment should be done according to platelet counts, and maximum dose should not exceed 60 mg daily. Subjects whose platelet count ≤100×109/L，the Avatrombopag dose will maintain. If platelet count \>100×109/L for 2 weeks, the subjects need to reduce the dose of Avatrombopag to the next lower dose or lower frequency. If subjects whose platelet count exceeds 100×109/L for 4 weeks，already have reduced the dose of Avatrombopag to 20mg once every other day or lower frequency during the treatment period, Avatrombopag can be stopped for observation, until platelet counts fall below 100×109/L. If the subjects do not need further chemotherapy or radiotherapy, the subjects can taper off Avatrombopag if the platelet is greater than 50×109/L.

Yunfei Chen, MD

Lei Zhang, MD

To evaluate the efficacy and safety of Avatrombopag to treat chemotherapy-induced thrombocytopenia in solid tumors

The investigator had registered a clinical trial of Eltrombopag in the treatment of chemotherapy-induced thrombocytopenia（NCT04600960）. Due to the late launch of Avatrombopag in China, the investigator also collected the information of Avatrombopag in the treatment of chemotherapy-induced thrombocytopenia according to the protocal of Eltrombopag in the treatment of chemotherapy-induced thrombocytopenia（NCT04600960）.

This is a single-arm study to evaluate the safety and efficacy of Avatrombopag to treat chemotherapy-induced thrombocytopenia （CIT）in solid tumors. These subjects have been treated with recombinant human thrombopoietin（rhTPO） or interleukin 11（IL-11） before, the platelets can rise to normal or reach the effective standard, but after the re-application, the effective standard is not reached, or the effective standard is still not reached after the rhTPO 300U/kg/d treatment for 14 days. The investigator will assess the changes of the platelet counts after the treatment of Avatrombopag from week 1 to week 24, and observe incidence of adverse events during the treatment of Avatrombopag. The investigator will complete the 4 weeks safety visits（once a week），if the subjects end or withdraw from the clinical trial.

Patients with chemotherapy-induced thrombocytopenia who had the same inclusion and exclusion criteria in the same period or in the past will be compared with the efficacy and safety of supportive treatment and Eltrombopag or Herombopag treatment in the same period or history, so as to preliminarily explore and evaluate the efficacy and safety of Avatrombopag treatment.

Avatrombopag for Chemotherapy-induced Thrombocytopenia

Avatrombopag for Chemotherapy-induced Thrombocytopenia in Solid Tumors: a Prospective Multi-center One-arm Study

Researchers qualified can request the dataset, including de-identified individual subject data. Data may be requested from PI from 12 months 36 months after study completion.

The investigator will assess the changes of the platelet counts after the treatment of Avatrombopag from week 1 to week 24，and calculate the proportion of subjects ≥ 30 × 10\^9/L ， 50 × 10\^9/L and 100 × 10\^9/L at week 12 and week 24.

The investigator will observe incidence of adverse events after the treatment of Avatrombopag, including thrombosis, diarrhea, skin rash, abnormal liver function and so on.

The investigator will observe the concentration of TPO in peripheral blood before and after the treatment of Avatrombopag, if necessary.

The investigator will observe the concentration of antibodies in peripheral blood before and after the treatment of Avatrombopag, if necessary

Tianjin Medical University Cancer Institute and Hospital

Tianjin Medical University Second Hospital

Tianjin Third Central Hospital

Tianjin People's Hospital

Henan Cancer Hospital

The Second Affiliated Hospital of Kunming Medical University

Institute of Hematology & Blood Diseases Hospital, China

vice Director of Thrombosis and Hemostasis Center

Immunomodulating Agents

Avartripopa is a new generation of oral TPO receptor agonist that simulates the biological effects of TPO in vitro and in vivo.

TPO stimulates megakaryocytes through binding and activation of TPO receptor, which is expressed in hematopoietic stem cells, megakaryotic cell lines and platelets.

By binding to the transmembrane region of the thrombopoietin receptor, Ava Tripopa activates the thrombopoietin receptor in humans, stimulates signal transduction and mimics the biological effects of thrombopoietin, leading to an increase in platelet count.

* Participants meeting the eligibility criteria receive Avatrombopag treatment (orally, 60 mg/day), for a maximum course of 20 days.
* Investigation product withdrawal: PLT ≥75×109/L or increases by at least 50×109/L from the lowest value after targeted therapy and immunotherapy combination treatment.

Yanyu Wang, MD

Haitao Haitao, Prof

Xiao-Bo Xiao-Bo, MD

Hai-Tao Zhao, MD

To evaluate the efficacy and safety of Avatrombopag in patients with thrombocytopenia induced by targeted therapy and immunotherapy combination treatment, and provide evidence-based medication for the clinical use of Avatrombopag in patients with PC ≤50×109/L

This phase II trial is a single-arm, non-randomized and single-center clinical study.

It is estimated that 30 patients who met the study criteria will be enrolled in PUMCH and treated with Avatrombopag. The investigators will follow up and collect subjects' data each month to evaluate the efficacy and safety of treatment. Primary outcome measure is percentage of participants whose PLT reaches ≥75×109/L, or increases by ≥50×109/L or ≥100% from baseline at least once within 20 days of initial treatment.

Secondary outcome measure:1)Number of days required for PLT to reach ≥50×109/L after treatment; 2)Number of days required for PLT to reach ≥75×109/L after treatment; 3)Percentage of subjects without platelet transfusion within 20 days of treatment; 4)Percentage of subjects without clinically relevant bleeding within 20 days of treatment.

Study Type: Interventional. Masking: Open Label.

Patients receiving combined targeted therapy (including but not limited to tyrosine kinase inhibitors, cyclin-dependent kinase inhibitors) with immunotherapy (including but not limited to PD-1 inhibitors and/or PD-L1 inhibitors and/or CTLA-4 inhibitors); Patients experienced grade III or above thrombocytopenia (PC ≤50×109/L) at least once within 48 h of the screening period;

Efficacy and Safety of Avatrombopag in Cancer Patients With Thrombocytopenia

Efficacy and Safety of Avatrombopag in Cancer Patients With Thrombocytopenia Induced by Targeted Therapy and Immunotherapy Combination Treatment

Percentage of participants whose PLT reaches ≥75×109/L, or increases by ≥50×109/L or ≥100% from baseline at least once within 20 days of initial treatment.

Peking Union Medical College Hospital

Patients will receive an initial dose of Avatrombopag 60 mg on Day 1.Starting on Day 2, the dose will be Avatrombopag 20 mg daily.

Patients will receive an initial dose of Avatrombopag 60 mg on Day 1. Starting on Day 2, the dose will be Avatrombopag 20 mg daily. Once a patient has reached a platelet target of \> 100,000/mcL patients can initiate systemic cancer therapy. Avatrombopag will be continued as maintenance (subscript "m") and titrated weekly with a goal to maintain a platelet count of ≥ 100,000/mcL during administration of systemic cancer therapy. Duration of maintenance therapy will be at least 12 weeks (indicated by Week 1m, Week 2m, ... 12m) starting from time of platelet correction and resumption of systemic cancer therapy. End of Treatment (EOT) is up to 15 weeks on study Week 12m.

This study will test whether avatrombopag is an effective treatment for thrombocytopenia in people who have both cancer and a liver disease (such as cirrhosis, cholangitis, or hepatitis). Researchers will look at whether giving participants avatrombopag for 3 weeks can raise their platelet levels enough for them to begin chemotherapy. The study will also test whether avatrombopag can continue to be effective against thrombocytopenia while participants are on chemotherapy for 12 weeks or longer. In addition, researchers will determine how safe the study drug is in participants.

A Phase II single arm study will be an open label study examining the use of Avatrombopag.

Avatrombopag for Thrombocytopenia in People With Cancer

Clinical Trial of Avatrombopag for Thrombocytopenia in Cancer, A Phase II Single Arm Study

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

the platelet count is ≥ 100,000/mcL, this will be considered successful achievement of the primary endpoint

without platelets dropping below 100,000/mcL on the day of the start of next scheduled cycle of systemic cancer therapy

Sobi, Inc.

Memorial Sloan Kettering Cancer Center

When patient is diagnosed with thrombocytopenia induced by chemotherapy of malignant tumor, avatrombopag will be given to patients as a therapeutic plan.

10×109/L\<PLT\<75×109/L, avatrombopag tablet 60 mg once a day for 5-10 days.

To observe the clinical efficacy and safety of avatrombopag for chemotherapy-induced thrombocytopenia in patients with malignant tumors.

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.

Avatrombopag on the Treatment of Thrombocytopenia Induced by Chemotherapy of Malignant Tumors

A Single-arm, Multi-center, Open Clinical Study of Avatrombopag on the Treatment of Thrombocytopenia Induced by Chemotherapy of Malignant Tumors

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.

Anhui Provincial Cancer Hospital

Professor

Study is 2:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 5 days prior to chemotherapy and 5 days following chemotherapy treatment.

Placebo Oral Tablet

Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of avatrombopag in subjects with chemotherapy-induced thrombocytopenia receiving chemotherapy for the treatment of ovarian, lung (small cell and non-small cell) and bladder cancer.

Subjects will receive placebo controlled test treatment for one cycle of chemotherapy followed by an observational cycle. Subjects will have the option to continue into an open label extension period for all remaining chemotherapy cycles within the current regimen. After the follow-up visit, all subjects will continue to a long-term safety follow-up period.

Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers

Randomized, Double-Blind, Placebo-Controlled Study With Open-Label Extension to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Active Non-Hematological Cancers

The duration of severe thrombocytopenia is defined as the total number of days with a platelet count \<50×10\^9/L during the period after post-chemotherapy study drug treatment in Cycle X+1 through Chemotherapy Day of Cycle X+2.

Comparison of avatrombopag 60 mg vs. placebo, adjusted for the number of chemotherapy agents currently receiving per IWRS (1, ≥2).

Cycle X nadir is defined as the lowest platelet count value prior to the first dose of study drug; Cycle X+1 nadir is defined as the lowest platelet count value during the period after post-chemotherapy study drug treatment in Cycle X+1 through Chemotherapy Day in Cycle X+2.

Adverse events were assessed by Investigators at each study visit.

Placebo Oral Tablet: Placebo comparator tablet

Placebo

Study is 2:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 5 days prior to chemotherapy and 5 days following chemotherapy treatment.

Avatrombopag: Oral avatrombopag tablet

Study is 2:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 5 days prior to chemotherapy and 5 days following chemotherapy treatment.

Placebo Oral Tablet: Placebo comparator tablet

Total

Age at Enrollment

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Subjects with ECOG Score 0

Subjects with ECOG Score 1

Subjects with ECOG Score 2

The Eastern Cooperative Oncology Group (ECOG) performance status score describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). 0=Fully active, able to carry on all pre-disease performance without restriction 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2=Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours

ECOG Performance Status

Subjects Receiving 1 Agent

Subjects Receiving ≥ 2 Agents

Number of Eligible Chemotherapy Agents Currently Receiving per IWRS

Baseline Platelet Count (x10⁹/L)

Height (cm)

Weight (kg)

BMI (kg/m²)

VP of Global Drug Development

Percentage of Subjects Who do Not Require Platelet Transfusion, Dose Reduction in Chemotherapy by 15%, or Chemotherapy Delay by >=4 Days

Duration of Severe Thrombocytopenia Defined as a Platelet Count <50 x 10^9/L

Change in Platelet Count From Baseline (Nadir)

Percentage of Subjects Who Did Not Have Major or Non-major Clinically Relevant Bleeding During the Period After Post-chemotherapy Study Drug Treatment in Cycle X+1 Through Chemotherapy Day of Cycle X+2.

Study is 2:1 randomization ratio (avatrombopag to placebo). 60 mg of Investigational product administered orally once daily for 5 days prior to chemotherapy and 5 days following chemotherapy treatment.

Avatrombopag: Oral avatrombopag tablet

Study is 2:1 randomization ratio (avatrombopag to placebo). 60 mg Investigational product administered orally once daily for 5 days prior to chemotherapy and 5 days following chemotherapy treatment.

Placebo Oral Tablet: Placebo comparator tablet

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Avatrombopag for the Primary Prevention of Thrombocytopenia Induced by Cytarabine-based Chemotherapy in Patients With Lymphoma	NCT04797182	Thrombocytopeni... Cytarabine Caus... Lymphoma	avatrombopag	18 Years - 70 Years	Sun Yat-sen University
Treatment of Avatrombopag for Thrombocytopenia in Patients Undergoing Selective Resection of Hepatocellular Carcinoma	NCT05087459	Thrombocytopeni...	Avatrombopag	18 Years -	Shanghai Zhongshan Hospital
Avatrombopag vs. Placebo for CIT in GI Malignancies	NCT05772546	Gastrointestina... Gastrointestina... Chemotherapy-In...	Avatrombopag Matching Placeb...	18 Years -	Massachusetts General Hospital
Avatrombopag for HCC Patients With Thrombocytopenia Who Intend to Undergo TACE and/or HAIC	NCT06001567	Thrombocytopeni... Hepatocellular ...	Avatrombopag	18 Years -	Second Affiliated Hospital of Guangzhou Medical University
Avatrombopag for Chemotherapy-induced Thrombocytopenia	NCT05218226	Chemotherapy-in... Avatrombopag	Avatrombopag	18 Years -	Institute of Hematology & Blood Diseases Hospital, China
Efficacy and Safety of Avatrombopag in Cancer Patients With Thrombocytopenia	NCT04896528	Thrombocytopeni... Avatrombopag	Avatrombopag	18 Years - 85 Years	Peking Union Medical College Hospital
Avatrombopag vs. Placebo for CIT in GI Malignancies	NCT05772546	Gastrointestina... Gastrointestina... Chemotherapy-In...	Avatrombopag Matching Placeb...	18 Years -	Massachusetts General Hospital
Avatrombopag for Thrombocytopenia in People With Cancer	NCT04437953	Thrombocytopeni... Cancer Liver Diseases	Avatrombopag	18 Years -	Memorial Sloan Kettering Cancer Center
Avatrombopag on the Treatment of Thrombocytopenia Induced by Chemotherapy of Malignant Tumors	NCT04609891	Thrombocytopeni...	Avatrombopag	18 Years - 75 Years	Anhui Provincial Cancer Hospital
Avatrombopag for HCC Patients With Thrombocytopenia Who Intend to Undergo TACE and/or HAIC	NCT06001567	Thrombocytopeni... Hepatocellular ...	Avatrombopag	18 Years -	Second Affiliated Hospital of Guangzhou Medical University
Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers	NCT03471078	Chemotherapy-in...	Avatrombopag Placebo Oral Ta...	18 Years -	Sobi, Inc.
Avatrombopag vs. Placebo for CIT in GI Malignancies	NCT05772546	Gastrointestina... Gastrointestina... Chemotherapy-In...	Avatrombopag Matching Placeb...	18 Years -	Massachusetts General Hospital

Spots Global Cancer Trial Database for avatrombopag

Every month we try and update this database with for avatrombopag cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.