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NCT07286032PHASE3Recruiting

A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia (ExCIT)

Jiangsu HengRui Medicine Co., Ltd.

Start Date

4/16/2026

Completion Date

6/1/2029

Summary

The ExCIT study is being conducted to evaluate the efficacy, and safety of of Hetrombopag Olamine Tablets Vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Male or female, age ≥ 18 years at screening. 2. Histologically or cytologically confirmed solid tumor (e.g., non-small-cell lung carcinoma \[NSCLC\], breast, ovarian, bladder, pancreatic, gastrointestinal, or colon/colorectal cancer). 3. Receiving platinum- and/or gemcitabine-containing chemotherapy regimens on 14- or 21-day treatment cycles. 4. Platelet count \< 85 x 109/L at enrollment. 5. For Part B, experiencing a chemotherapy delay of ≥ 7 days due to CIT. 6. At least 2 scheduled chemotherapy cycles of the same treatment regimen as was used prior to enrollment. 7. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2. 8. Life expectancy ≥6 months. 9. Signed ICF for voluntary participation in the study and good compliance. Exclusion Criteria: 1. WHO Grade ≥ 2 bleeding within 14 days prior to screening. 2. Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia). 3. Hematologic malignancies. 4. Thrombocytopenia caused by reasons other than chemotherapy, including but not limited to chronic liver disease, hypersplenism, infection, and hemorrhage, within 6 months prior to Study Day 1. 5. Untreated brain metastases; or with leptomeningeal metastasis. 6. Conditions that require emergent treatment (e.g., superior vena cava syndrome, spinal cord compression). 7. Severe cardiovascular disorders or interventions within 6 months. 8. Have arterial/venous thrombosis with anticoagulation not tolerated for at least 6 weeks. 9. Known bleeding disorders, platelet dysfunction. 10. Severe haemorrhage during screening (e.g., gastrointestinal or intracranial hemorrhage) within 28 days prior to enrolment. 11. Previous treatment with thrombopoietin receptor agonists (TPO-RAs) within 14 days prior to enrolment. 12. Platelet transfusion within 72 hours prior to enrollment. 13. Acute or uncontrolled hepatitis B\&C infection. 14. Human immunodeficiency virus (HIV) infection.

Interventions

DRUG

Hetrombopag Olamine

DRUG

Hetrombopag Olamine; Hetrombopag Olamine Placebo

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Conditions

Patients With Chemotherapy-Induced Thrombocytopenia

Locations

Starling Oncology

Long Beach, California 90805

United States

Cancer and Blood Specialty Clinic

Los Alamitos, California 90254

United States

UCLA

Los Angeles, California 90095

United States

Clermont Oncology Center

Clermont, Florida 34711

United States

Oncology & Hematology Associates of West Broward

Coral Springs, Florida 33065

United States

Starling Oncology / Oncology Institute of Hope & Innovation

Miami, Florida 33141

United States

Mid-Florida Hematology & Oncology Centers, P.A.

Orange City, Florida 32763

United States

Springfield Clinic

Springfield, Illinois 62702

United States

University of Iowa

Iowa City, Iowa 52242

United States

Hattiesburg Clinic Hematology/Oncology

Hattiesburg, Mississippi 39401

United States

Cancer Partners of Nebraska

Lincoln, Nebraska 68516

United States

Morristown Medical Center

Morristown, New Jersey 07039

United States

MSK Cancer Center

New York, New York 10065

United States

New York Cancer and Blood Specialists One Oncology

Shirley, New York 11967

United States

ARENSIA Exploratory Medicine at "MBAL Sveta Sofia"

Sofia,

Bulgaria

UMHAT "Sv. Ivan Rilski", EAD

Sofia,

Bulgaria

Hong Kong United Oncology Centre

Hong Kong, Hong Kong 000000

China

The Chinese University of Hong Kong

Hong Kong, Hong Kong 000000

China

The University of Hong Kong

Hong Kong, Hong Kong 000000

China

Gustave Roussy Cancer Campus

Clémont,

France

Centre Hospitalier Lyon Sud

Lyon,

France

Groupe Hospitalier Pitie-Salpetriere

Paris,

France

Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

Bari,

Italy

Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

Milan,

Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan,

Italy

Fondazione IRCCS Policlinico San Matteo

Pavia,

Italy

Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. ks. B. Markiewicza

Brzozów,

Poland

Uniwersytecki Szpital Kliniczny w Poznaniu, Klinika Onkologii

Poznan,

Poland

Institutul Oncologic Bucuresti Prof Dr. Al. Trestioreanu with SC Arensia Exploratory Medicine

Bucharest,

Romania

Institute of Oncology "Ioan Chiricuta" Cluj-Napoca, Arensia Exploratory Medicine

Cluj-Napoca,

Romania

Centrul de Oncologie Sfantul Nectarie Craiova

Craiova,

Romania

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do 13620

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Pratia ES Sirius Barcelona

Barcelona,

Spain

Hospital Universitario Reina Sofía Córdoba

Córdoba,

Spain

Hospital Universitari Arnau de Vilanova

Lleida,

Spain

Hospital Universitario HM Madrid Sanchinarro

Madrid,

Spain

Hospital Universitario Ramón y Cajal

Madrid,

Spain

Pratia ES Hospital Universitario de Torrejon

Madrid,

Spain

Complejo Hospitalario Universitario de Orense

Ourense,

Spain

Hospital Universitario General de Cataluña

Sant Cugat del Vallès,

Spain

Ankara Univ Cebeci Hospital Medical Oncology

Mamak, Ankara

Turkey (Türkiye)

Istanbul Univ. Cerrahpasa Medical Faculty Hosp.

Fatih, Istanbul

Turkey (Türkiye)

Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Kadıköy, Istanbul

Turkey (Türkiye)

Marmara University Pendik Training and Research Hospital

Pendik, Istanbul

Turkey (Türkiye)

I.E.U. Medicalpoint Izmir Hospital

Izmir,

Turkey (Türkiye)

Pamukkale University Hospital

Kınıklı,

Turkey (Türkiye)

Sakarya Univ. Training & Research Hosp. Oncology

Sakarya,

Turkey (Türkiye)

Ankara Oncology TRH Clinical Research Center

Yenimahalle,

Turkey (Türkiye)

ARENSIA Exploratory Medicine LLC

Kyiv,

Ukraine