Clinical Trials List
2016-05-01 - 2020-12-31
Phase II
Terminated5
ICD-10D01.5
Carcinoma in situ of liver, gallbladder and bile ducts
ICD-10C22.0
Liver cell carcinoma
ICD-10C22.1
Intrahepatic bile duct carcinoma
ICD-10C24
Malignant neoplasm of other and unspecified parts of biliary tract
ICD-10C24.9
Malignant neoplasm of biliary tract, unspecified
ICD-9230.8
Carcinoma in situ of liver and biliary system
Randomized, Double-Blind, Phase 2 Study of Ramucirumab or Merestinib or Placebo plus Cisplatin and Gemcitabine as First-Line Treatment in Patients with Advanced or Metastatic Biliary Tract Cancer.
-
Trial Applicant
ELI LILLY AND COMPANY(TAIWAN), INC.
-
Sponsor
Eli Lilly and Company
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Yi-Ping Hung Division of Hematology & Oncology
- Chung-Pin Li Digestive System Department
- Yi-Hsiang Huang Digestive System Department
- Rheun-Chuan Lee Division of Radiology
The Actual Total Number of Participants Enrolled
3 Terminated
Audit
None
Co-Principal Investigator
- Che-Hung Lin Division of Hematology & Oncology
- Chang-Fang Chiu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
Audit
CRO
Taiwan National PI
Co-Principal Investigator
- Hung-Chih Hsu Division of Hematology & Oncology
- Mengting Peng Division of Hematology & Oncology
- Ming-Mo Hou Division of Hematology & Oncology
- Po-Jung Su Division of Hematology & Oncology
- Wen-Chi Chou Division of Hematology & Oncology
- Chia-Hsun Hsieh Division of Hematology & Oncology
- Chan-Keng Yang Division of Hematology & Oncology
- Tsai-Sheng Yang Division of Hematology & Oncology
- Yung-Chia Kao Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
7 Terminated
Audit
CRO
Co-Principal Investigator
- Hui-Jen Tsai Division of Hematology & Oncology
- Chia-Jui Yen Division of Hematology & Oncology
- Kwang-Yu Chang Division of Hematology & Oncology
- Yan-Shen Shan Division of General Surgery
- 姜乃榕 Division of Hematology & Oncology
- Nai-Jung Chiang Division of Hematology & Oncology
- Shang-Hung Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Ramucirumab
Dosage Form
Oral
Dosage
40
Endpoints
1. Progression Free Survival (PFS).
Secondary Outcome Measures:
1. Overall Survival (OS).
2. Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR).
3. Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR).
4. Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab.
5. PK: Plasma Concentration of Merestinib.
6. Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies.
7. Change From Baseline in Functional Assessment of Cancer Therapy Hepatobiliary Questionnaire (FACT-Hep).
8. Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score.
9. Change From Baseline in Participant-Reported EQ-5D-5L Visual Analog Scale (VAS) Score.
Inclution Criteria
2. Have a histologically or cytologically confirmed diagnosis of non-resectable, recurrent, or metastatic biliary tract adenocarcinoma (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or Ampulla of Vater) .
3. Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST).
4. Have adequate biliary drainage.
5. Have adequate organ function.
6. Males and females are sterile, postmenopausal, or compliant with a highly effective contraceptive method.
7. Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dose.
8. Are willing to provide blood/serum/plasma and tumor tissue samples for research purposes. Submission of blood/serum/plasma and tumor tissue samples is mandatory for participation in this study, unless restricted per local regulations.
Exclusion Criteria
2. Have a history of or have current hepatic encephalopathy of any grade, or ascites of Grade >1, or cirrhosis with Child-Pugh Stage B or higher.
3. Have ongoing or recent (≤6 months) hepatorenal syndrome.
4. Have had a major surgical procedure or significant traumatic injury including nonhealing wound, peptic ulcer, or bone fracture ≤28 days prior to randomization.
5. Anticipate having a major surgical procedure during the course of the study.
6. Has documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression.
7. Within 6 months prior to randomization, have had any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack.
8. Have an uncontrolled arterial hypertension with systolic blood pressure ≥150 or diastolic blood pressure ≥90 millimeters of mercury (mm Hg) despite standard medical management.
9. Have a previous malignancy within 5 years of study entry or a concurrent malignancy.
10. Have a history of gastrointestinal perforation and/or fistulae within 6 months prior to randomization.
11. Have a known allergy or hypersensitivity reaction to any of the treatment components.
12. Have a history of uncontrolled hereditary or acquired thrombotic disorder.
13. Have uncontrolled metabolic disorders or other nonmalignant organ or systemic diseases or secondary effects of cancer that induce a high medical risk and/or make assessment of survival uncertain.
14. Have mixed hepatocellular biliary tract cancer histology.
15. Have a corrected QT interval >470 milliseconds as calculated by the Fridericia equation.
The Estimated Number of Participants
-
Taiwan
20 participants
-
Global
300 participants
