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

NCT07286032 | Recruiting Phase 3 FDA Drug

• 1 other identifier: SHR8735-303
• Study Type: interventional
• Target: 150
• Locations: 11 countries
• Sites: 51

Brief 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.

Conditions

Patients With Chemotherapy-Induced Thrombocytopenia

Outcome Measures

Primary Outcomes (6)

• Part A: Cmax of hetrombopag in non-Asian participants with CIT, around 6 months.

  around 6 months.

• Part A: AUC0-tauof hetrombopag in non-Asian participants with CIT, around 6 months.

  around 6 months.

• Part A: Cmin of hetrombopag in non-Asian participants with CIT, around 6 months.

  around 6 months.

• Part B: A platelet count of ≥100×109/L within 14 days after initiating the investigational product treatment, around 3 years.

  around 3 years.

• Part B: No use of any rescue therapy for thrombocytopenia during the treatment period from the initiation of investigational product treatment until the end of the primary treatment period, around 3 years.

  around 3 years.

• Part B: Complete two consecutive on-study chemotherapy cycles (Cycle 1 and Cycle 2) without thrombocytopenia-induced modification of any myelosuppressive agent, around 3 years.

  around 3 years.

Secondary Outcomes (5)

• Proportion of participants achieving platelet count ≥100×109/L without the use of rescue therapy within 14 days after initiating the investigational product treatment, around 3 years.

  around 3 years.

• Platelet count nadir from Cycle 1 Day 1 until the primary treatment period, around 3 years.

  around 3 years.

• Proportion of participants free from serious bleeding events, during the treatment period from the initiation of IP treatment until the primary treatment period, around 3 years.

  around 3 years.

• Proportion of participants with neutropenia during the treatment period from the initiation of IP treatment until the primary treatment period, around 3 years.

  around 3 years.

• Number of Adverse Events/Serious Adverse Events, safety lab parameters, vital signs, etc within study period, around 3 years.

  around 3 years.

Study Arms (2)

Part A: Hetrombopag Olamine

EXPERIMENTAL

Drug: Hetrombopag Olamine

Part B: Hetrombopag Olamine vs Hetrombopag Olamine Placebo

EXPERIMENTAL

Drug: Hetrombopag Olamine; Hetrombopag Olamine Placebo

Interventions

Hetrombopag Olamine DRUG

For Part A, all participants would receive hetrombopag treatment.

Part A: Hetrombopag Olamine

Hetrombopag Olamine; Hetrombopag Olamine Placebo DRUG

For Part B, participants would be randomized to receive hetrombopag treatment or matching placebo, respectively.

Part B: Hetrombopag Olamine vs Hetrombopag Olamine Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age ≥ 18 years at screening.
• Histologically or cytologically confirmed solid tumor (e.g., non-small-cell lung carcinoma \[NSCLC\], breast, ovarian, bladder, pancreatic, gastrointestinal, or colon/colorectal cancer).
• Receiving platinum- and/or gemcitabine-containing chemotherapy regimens on 14- or 21-day treatment cycles.
• Platelet count \< 85 x 109/L at enrollment.
• For Part B, experiencing a chemotherapy delay of ≥ 7 days due to CIT.
• At least 2 scheduled chemotherapy cycles of the same treatment regimen as was used prior to enrollment.
• Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
• Life expectancy ≥6 months.
• Signed ICF for voluntary participation in the study and good compliance.

You may not qualify if:

• WHO Grade ≥ 2 bleeding within 14 days prior to screening.
• Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia).
• Hematologic malignancies.
• 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.
• Untreated brain metastases; or with leptomeningeal metastasis.
• Conditions that require emergent treatment (e.g., superior vena cava syndrome, spinal cord compression).
• Severe cardiovascular disorders or interventions within 6 months.
• Have arterial/venous thrombosis with anticoagulation not tolerated for at least 6 weeks.
• Known bleeding disorders, platelet dysfunction.
• Severe haemorrhage during screening (e.g., gastrointestinal or intracranial hemorrhage) within 28 days prior to enrolment.
• Previous treatment with thrombopoietin receptor agonists (TPO-RAs) within 14 days prior to enrolment.
• Platelet transfusion within 72 hours prior to enrollment.
• Acute or uncontrolled hepatitis B\&C infection.
• Human immunodeficiency virus (HIV) infection.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (51)

Starling Oncology

Long Beach, California, 90805, United States

NOT YET RECRUITING

Cancer and Blood Specialty Clinic

Los Alamitos, California, 90254, United States

RECRUITING

UCLA

Los Angeles, California, 90095, United States

RECRUITING

Clermont Oncology Center

Clermont, Florida, 34711, United States

RECRUITING

Oncology & Hematology Associates of West Broward

Coral Springs, Florida, 33065, United States

RECRUITING

Starling Oncology / Oncology Institute of Hope & Innovation

Miami, Florida, 33141, United States

NOT YET RECRUITING

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

Orange City, Florida, 32763, United States

RECRUITING

Springfield Clinic

Springfield, Illinois, 62702, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Hattiesburg Clinic Hematology/Oncology

Hattiesburg, Mississippi, 39401, United States

NOT YET RECRUITING

Cancer Partners of Nebraska

Lincoln, Nebraska, 68516, United States

RECRUITING

Morristown Medical Center

Morristown, New Jersey, 07039, United States

NOT YET RECRUITING

MSK Cancer Center

New York, New York, 10065, United States

NOT YET RECRUITING

New York Cancer and Blood Specialists One Oncology

Shirley, New York, 11967, United States

NOT YET RECRUITING

ARENSIA Exploratory Medicine at "MBAL Sveta Sofia"

Sofia, Bulgaria

RECRUITING

UMHAT "Sv. Ivan Rilski", EAD

Sofia, Bulgaria

NOT YET RECRUITING

Hong Kong United Oncology Centre

Hong Kong, Hong Kong, 000000, China

NOT YET RECRUITING

The Chinese University of Hong Kong

Hong Kong, Hong Kong, 000000, China

NOT YET RECRUITING

The University of Hong Kong

Hong Kong, Hong Kong, 000000, China

NOT YET RECRUITING

Gustave Roussy Cancer Campus

Clémont, France

RECRUITING

Centre Hospitalier Lyon Sud

Lyon, France

NOT YET RECRUITING

Groupe Hospitalier Pitie-Salpetriere

Paris, France

NOT YET RECRUITING

Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

Bari, Italy

NOT YET RECRUITING

Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

Milan, Italy

NOT YET RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

NOT YET RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

NOT YET RECRUITING

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

Brzozów, Poland

NOT YET RECRUITING

Uniwersytecki Szpital Kliniczny w Poznaniu, Klinika Onkologii

Poznan, Poland

NOT YET RECRUITING

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

Bucharest, Romania

RECRUITING

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

Cluj-Napoca, Romania

RECRUITING

Centrul de Oncologie Sfantul Nectarie Craiova

Craiova, Romania

NOT YET RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

NOT YET RECRUITING

Pratia ES Sirius Barcelona

Barcelona, Spain

RECRUITING

Hospital Universitario Reina Sofía Córdoba

Córdoba, Spain

NOT YET RECRUITING

Hospital Universitari Arnau de Vilanova

Lleida, Spain

NOT YET RECRUITING

Hospital Universitario HM Madrid Sanchinarro

Madrid, Spain

NOT YET RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Spain

NOT YET RECRUITING

Pratia ES Hospital Universitario de Torrejon

Madrid, Spain

RECRUITING

Complejo Hospitalario Universitario de Orense

Ourense, Spain

NOT YET RECRUITING

Hospital Universitario General de Cataluña

Sant Cugat del Vallès, Spain

NOT YET RECRUITING

Ankara Univ Cebeci Hospital Medical Oncology

Mamak, Ankara, Turkey (Türkiye)

NOT YET RECRUITING

Istanbul Univ. Cerrahpasa Medical Faculty Hosp.

Fatih, Istanbul, Turkey (Türkiye)

NOT YET RECRUITING

Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Kadıköy, Istanbul, Turkey (Türkiye)

NOT YET RECRUITING

Marmara University Pendik Training and Research Hospital

Pendik, Istanbul, Turkey (Türkiye)

NOT YET RECRUITING

I.E.U. Medicalpoint Izmir Hospital

Izmir, Turkey (Türkiye)

NOT YET RECRUITING

Pamukkale University Hospital

Kınıklı, Turkey (Türkiye)

NOT YET RECRUITING

Sakarya Univ. Training & Research Hosp. Oncology

Sakarya, Turkey (Türkiye)

NOT YET RECRUITING

Ankara Oncology TRH Clinical Research Center

Yenimahalle, Turkey (Türkiye)

NOT YET RECRUITING

ARENSIA Exploratory Medicine LLC

Kyiv, Ukraine

RECRUITING

Central Study Contacts

Brian Yu, MD

CONTACT

+86 400 828 3900; brian.yu@hengrui.com

Junye Xiong, MD

CONTACT

+86-0518-82342973; junye.xiong.jx9@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A should be completed firstly then move to Part B. Non-randomized for Part A, Randomized for Part B.

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 16, 2025
• Study Start: April 16, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

US (14); PL (2); ES (8); FR (3); KR (3); BU (2); CN (3); IT (4); TU (8); UA (1); RO (3)