A Phase I / II Trial of Nintedanib in Asian Hepatocellular Carcinoma Patients
Launched by BOEHRINGER INGELHEIM · Sep 30, 2009
Trial Information
Current as of June 25, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • 1. Hepatocellular carcinoma, either histologically/cytologically confirmed or clinically diagnosed, which is not amenable to curative surgery or loco-regional therapy
- • 2. Age 18 years or older
- • 3. Eastern Cooperative Group performance score of 2 or less
- • 4. Child-Pugh score of 7 or less
- • 5. Written informed consent in accordance with International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) and local legislation
- Exclusion criteria:
- • 1. Prior systemic therapy for metastatic/unresectable hepatocellular carcinoma (for phase II)
- • 2. More than one line of prior systemic therapy for metastatic/unresectable hepatocellular carcinoma (for phase I)
- • 3. Uncontrolled or refractory ascites to adequate medical therapy
- • 4. Bilirubin greater than 1.5 times upper limit of normal
- • 5. Aspartate amino transferase or alanine amino transferase greater than 5 times upper limit of normal
- • 6. Absolute neutrophil count less than 1500/microliter
- • 7. Platelet count less than 75000/microliter
- • 8. Hemoglobin less than 9 g/dL
- • 9. Serum creatinine greater than 1.5 times upper limit of normal
About Boehringer Ingelheim
Boehringer Ingelheim is a global, research-driven pharmaceutical company dedicated to improving health and quality of life through innovative therapies. Established in 1885 and headquartered in Ingelheim, Germany, the company focuses on the development of prescription medicines in key therapeutic areas, including respiratory diseases, cardiovascular health, oncology, and immunology. Boehringer Ingelheim is committed to advancing medical science through rigorous clinical trials and collaborative research, striving to bring novel treatments to patients while upholding the highest standards of safety and efficacy. With a strong emphasis on sustainability and corporate responsibility, the company aims to make a meaningful impact on global health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Changhua, , Taiwan
Kaohsiung, , Taiwan
Kaohsiung, , Taiwan
Taichung, , Taiwan
Tainan City, , Taiwan
Tainan, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taoyuan County, , Taiwan
Yunlin County, , Taiwan
Patients applied
Trial Officials
Boehringer Ingelheim
Study Chair
Boehringer Ingelheim
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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