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Recruiting Phase 3

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

NCT07286032 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 3
Started
2026-04-16
Last updated
2026-10-01

Condition(s) studied

Patients With Chemotherapy-Induced Thrombocytopenia

Investigational drug(s) / intervention(s)

Hetrombopag Olamine →Hetrombopag Olamine; Hetrombopag Olamine Placebo

Hetrombopag Olamine: For Part A, all participants would receive hetrombopag treatment.

Hetrombopag Olamine; Hetrombopag Olamine Placebo: For Part B, participants would be randomized to receive hetrombopag treatment or matching placebo, respectively.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (51)

FacilityCityRegionStatus
Starling Oncology Long Beach California Not Yet Recruiting
Cancer and Blood Specialty Clinic Los Alamitos California Recruiting
UCLA Los Angeles California Recruiting
Clermont Oncology Center Clermont Florida Recruiting
Oncology & Hematology Associates of West Broward Coral Springs Florida Recruiting
Starling Oncology / Oncology Institute of Hope & Innovation Miami Florida Not Yet Recruiting
Mid-Florida Hematology & Oncology Centers, P.A. Orange City Florida Recruiting
Springfield Clinic Springfield Illinois Recruiting
University of Iowa Iowa City Iowa Recruiting
Hattiesburg Clinic Hematology/Oncology Hattiesburg Mississippi Not Yet Recruiting
Cancer Partners of Nebraska Lincoln Nebraska Recruiting
Morristown Medical Center Morristown New Jersey Not Yet Recruiting
MSK Cancer Center New York New York Not Yet Recruiting
New York Cancer and Blood Specialists One Oncology Shirley New York 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 Not Yet Recruiting
The Chinese University of Hong Kong Hong Kong Hong Kong Not Yet Recruiting
The University of Hong Kong Hong Kong Hong Kong 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 Recruiting
Seoul National University Hospital Seoul South Korea Recruiting
Asan Medical Center Seoul 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

+ 11 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07286032 on ClinicalTrials.gov ↗ ← All trials in South Korea