A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia (ExCIT)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
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 Italy