Rafutrombopag ethanolamine for Chemotherapy-induced thrombocytopenia|Solid tumor

Inclusion criteria

• {"criterion_text":"- Male or female gender, age ≥18 years at screening."}
• {"criterion_text":"- Histologically or cytologically confirmed solid tumor"}
• {"criterion_text":"- Receiving platinum- and/or gemcitabine-containing chemotherapy regimens on 21-day treatment cycles."}
• {"criterion_text":"- PC < 75×109/L at enrollment."}
• {"criterion_text":"- Experiencing a protocol-defined treatment delay of ≥7 days per chemotherapy cycle due to CIT with PC <75×109/L (Part B only)."}
• {"criterion_text":"- Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2."}
• {"criterion_text":"- Adequate organ and hematologic function"}
• {"criterion_text":"- Having non-Asian race and ethnicity (Part A only)."}

Exclusion criteria

• {"criterion_text":"- PC <25×109/L at screening."}
• {"criterion_text":"- Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia)."}
• {"criterion_text":"- Hematologic malignancies"}
• {"criterion_text":"- Untreated brain metastases; or with leptomeningeal metastasis."}
• {"criterion_text":"- Bone marrow involvement or bone marrow metastasis on routine imaging."}
• {"criterion_text":"- Have arterial/venous thrombosis within 6 months prior to Study Day 1"}
• {"criterion_text":"- Severe hemorrhage (e.g., gastrointestinal, or intracranial hemorrhage) within 28 days prior to Study Day 1."}

Primary endpoints

• {"endpoint_text":"- Part A: PK parameters (e.g., Cmax, AUC0-tau, Cmin) of hetrombopag in non-Asian participants with CIT.","definition_or_measurement_approach":"Pharmacokinetic parameters (e.g., Cmax, AUC0-tau, Cmin) measured in non-Asian participants (Part A)."}
• {"endpoint_text":"- Proportion of treatment responders meeting these criteria: 1. Platelet count (PC) ≥100×109 /L within 14 days after initiating IMP treatment (incl Day 14); 2. Complete two consecutive on-study chemotherapy cycles (C1 and C2) without thrombocytopenia-induced modification of any myelosuppressive agent; 3. No use of any rescue therapy for thrombocytopenia during the treatment period from the initiation of IP treatment until Day 21 of C2 (C2D21; window period: +4 days).","definition_or_measurement_approach":"Responder proportion defined by all three criteria measured during study: PC ≥100×10^9/L within 14 days of IP initiation (including Day 14); completion of C1 and C2 without thrombocytopenia-induced modification of myelosuppressive agents; no rescue therapy from IP initiation until C2D21 (window +4 days)."}

Secondary endpoints

• {"endpoint_text":"- Proportion of participants who completed two consecutive on-study chemotherapy cycles without thrombocytopenia-induced modification of any myelosuppressive agent.","definition_or_measurement_approach":"Proportion completing two consecutive on-study chemo cycles (C1 and C2) without thrombocytopenia-induced modification."}
• {"endpoint_text":"- Proportion of participants achieving PC ≥100×109 /L without the use of rescue therapy within 14 days after initiating the IP treatment (including Day 14)","definition_or_measurement_approach":"Proportion achieving platelet count ≥100×10^9/L within 14 days of IP initiation without rescue therapy (including Day 14)."}
• {"endpoint_text":"- Proportion of participants with at least a single incidence of rescue therapy.","definition_or_measurement_approach":"Proportion with ≥1 occurrence of rescue therapy during the treatment period."}
• {"endpoint_text":"- Time to rescue therapy free first platelet response of PC ≥100×109/L defined as the interval between the initiation of IP treatment and the first platelet response.","definition_or_measurement_approach":"Time (interval) from initiation of IP treatment to first platelet response PC ≥100×10^9/L without rescue therapy."}
• {"endpoint_text":"- Cumulative duration of platelet response of PC ≥100×109/L without the use of rescue therapy.","definition_or_measurement_approach":"Total number of days with PC ≥100×10^9/L without rescue therapy during the observation period."}
• {"endpoint_text":"- PC nadir from C1D1 until C2D21 (window period: +4 days).","definition_or_measurement_approach":"Minimum platelet count (nadir) measured from C1D1 through C2D21 (window +4 days)."}
• {"endpoint_text":"- Cumulative duration of severe thrombocytopenia, defined as the number of consecutive days with a PC of ≤50×109/L.","definition_or_measurement_approach":"Number of consecutive days with platelet count ≤50×10^9/L (cumulative duration)."}
• {"endpoint_text":"- Proportion of participants who completed two consecutive on-study chemotherapy cycles without treatment regimen modification.","definition_or_measurement_approach":"Proportion completing two consecutive on-study chemo cycles (C1 & C2) without any regimen modification."}
• {"endpoint_text":"- Proportion of participants with all cause events leading to treatment regimen modifications including dose reduction, delay, omission, or discontinuation.","definition_or_measurement_approach":"Proportion with events (any cause) that led to regimen modification: dose reduction, delay, omission, or discontinuation."}
• {"endpoint_text":"- Proportion of participants who are free from serious bleeding events, defined as Grade >=2 per the World Health Organization (WHO) bleeding scale, during the treatment period from the initiation of IP treatment until C2D21 (window period: +4 days).","definition_or_measurement_approach":"Proportion without WHO bleeding scale Grade ≥2 events from IP initiation until C2D21 (window +4 days)."}
• {"endpoint_text":"- Number and proportion of participants with adverse events (AEs)/serious adverse events (SAEs), safety laboratory parameters, vital signs, etc.","definition_or_measurement_approach":"Counts and proportions of AEs/SAEs and summaries of safety labs and vital signs over treatment period."}
• {"endpoint_text":"- Proportion of participants with neutropenia during the treatment period from the initiation of IP treatment until C2D21 (window period: +4 days).","definition_or_measurement_approach":"Proportion with neutropenia from IP initiation until C2D21 (window +4 days)."}
• {"endpoint_text":"- Proportion of non-Asian treatment responders who meet the following criteria (Part A only): 1) Platelet count (PC) of 100×109/L within 14 days after initiating the IP treatment (incl. Day 14); 2) Complete two consecutive on-study chemotherapy cycles (C1 and C2) without thrombocytopenia-induced modification of any myelosuppressive agent; 3) No use of any rescue therapy for thrombocytopenia during the treatment period from initiation of IMP treatment until Day 21 of C2 (C2D21; window period:+4d)","definition_or_measurement_approach":"Same responder definition as primary (Part B) applied to non-Asian participants (Part A only): combination of platelet threshold, completion of C1/C2 without modification, and no rescue therapy until C2D21 (window +4d)."}

Methods

• Recruitment materials and arrangements are documented (K1_Recruitment arrangements, K2 recruitment materials). File titles indicate use of Dr-to-Patient letters and Participant Brochures to inform and recruit patients.
• Study materials include localized brochures and informational materials in multiple languages (EN, RO, ES, FR, PL, BG), indicating language-specific recruitment materials/approach per country.

France

Latest Decision Or Authorization Date

21-04-2026

Number Of Sites

1

Number Of Participants

4

Romania

Latest Decision Or Authorization Date

22-04-2026

Number Of Sites

2

Number Of Participants

15

Poland

Latest Decision Or Authorization Date

23-04-2026

Number Of Sites

2

Number Of Participants

15

Bulgaria

Latest Decision Or Authorization Date

27-04-2026

Number Of Sites

2

Number Of Participants

11

Spain

Latest Decision Or Authorization Date

27-04-2026

Number Of Sites

2

Number Of Participants

13

Primary sponsor

Full Name

Jiangsu Hengrui Pharmaceuticals Co. Ltd.

Organisation Type

Pharmaceutical company

Country Of Registered Address

China

Contract research organisations

Name

IQVIA RDS (Shanghai) Co. Ltd.

Responsibilities

codes: 1,11,12,13,15 (includes 'Site management')

Name

Almac Clinical Services Limited

Responsibilities

code: 15 (IMP Labeling and Distribution)

Name

ARENSIA Exploratory Medicine GmbH

Responsibilities

codes: 13,14,15 (value: 'Site management'),2,5

Name

Iqvia Laboratories Limited

Responsibilities

codes: 15 (Distribution of sample testing kits; PK samples collection),4

Name

Frontage Laboratories (Shanghai) Co. Ltd.

Responsibilities

code: 4

Third parties

• {"country":"China","full_name":"Frontage Laboratories (Shanghai) Co. Ltd.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"MyData-TRUST","duties_or_roles":"code: 15 (Data Protection Officer duties)","organisation_type":"Industry"}
• {"country":"China","full_name":"IQVIA RDS (Shanghai) Co. Ltd.","duties_or_roles":"codes: 1,11,12,13,15 (includes 'Site management')","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"code: 15 (IMP Labeling and Distribution)","organisation_type":"Pharmaceutical company"}
• {"country":"Poland","full_name":"Pratia S.A.","duties_or_roles":"codes: 13,14,15 (value: 'Site'),2,5","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code: 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Germany","full_name":"ARENSIA Exploratory Medicine GmbH","duties_or_roles":"codes: 13,14,15 (value: 'Site management'),2,5","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Germany","full_name":"PharmaKorell GmbH","duties_or_roles":"code: 15 (IMP batch release)","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"codes: 15 (Distribution of sample testing kits; PK samples collection),4","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Advarra Inc.","duties_or_roles":"codes: 11,15 (value: 'Central IRB review')","organisation_type":"Non-Pharmaceutical company"}
• {"country":"France","full_name":"MyData-TRUST (France address)","duties_or_roles":"code: 15 (Data Protection Officer duties)","organisation_type":"Industry"}
• {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"code: 3","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Ascopharm Gp Novasco","duties_or_roles":"code: 15 (Patient Travel Reimbursement)","organisation_type":"Industry"}