Clinical Trials List
Protocol NumberCVM-005
NCT Number(ClinicalTrials.gov Identfier)NCT03600233
Active
2018-12-06 - 2025-12-31
Phase II
Recruiting4
Terminated3
ICD-10C7A.1
Malignant poorly differentiated neuroendocrine tumors
A Phase II, Open-label Study of CVM-1118 Administered Orally to Patients with Advanced Neuroendocrine Tumors
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Trial Applicant
Efficient Pharma Management Corp.
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Sponsor
TaiRx, Inc.
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Trial scale
Taiwan Multiple Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Ching-Chan Lin Division of Hematology & Oncology
- Chi-Ching Chen Division of Hematology & Oncology
- Ming-Hung Tsai Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yee Chao Division of Hematology & Oncology
- Yi-Ping Hung Division of Hematology & Oncology
- Rheun-Chuan Lee Division of Radiology
- Chung-Pin Li Digestive System Department
The Actual Total Number of Participants Enrolled
3 Recruiting
Audit
None
Co-Principal Investigator
Audit
None
National Taiwan University Hospital
Taiwan National PI
Wu-Chou Su
Co-Principal Investigator
- Yu-Min Yeh Division of Hematology & Oncology
- Chien-Chung Lin Division of Thoracic Medicine
- Wen-Pin Su Division of Hematology & Oncology
- Jui-Hung Tsai Division of Hematology & Oncology
- Yan-Shen Shan Division of General Surgery
- Wu-Chou Su Division of Hematology & Oncology
- Wei-Pang Chung Division of Hematology & Oncology
- Shang-Yin Wu Division of Hematology & Oncology
- Hui-Jen Tsai Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Co-Principal Investigator
- 余紹銘 Division of Hematology & Oncology
- 吳教恩 Division of Hematology & Oncology
- Hung-Chih Hsu Division of Hematology & Oncology
- 徐執中 Division of Hematology & Oncology
- Wen-Chi Chou Division of Hematology & Oncology
- 黃文冠 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Tsung -Chih Chen Division of Hematology & Oncology
- 鄭紹彬 Division of General Surgery
- CHENG-HSIEN LIN Division of Hematology & Oncology
- 滕傑林 Division of Hematology & Oncology
- ZHENG-WEI ZHOU Division of Hematology & Oncology
- Chieh-Lin Teng Division of Hematology & Oncology
- 吳峯旭 Division of General Surgery
- 廖苡君 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Li-Tzong Chen Digestive System Department
- Shih-Chang Chuang Division of Gastroenterological Surgery
- 李玫萱 Division of Thoracic Medicine
- Hui-Hua Hsiao Division of Hematology & Oncology
- Wang Yao-Kuang Digestive System Department
- Tsung-Jang Yeh Division of Gastroenterological Surgery
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 吳佳哲 Division of Hematology & Oncology
- 黃詩喻 Division of Hematology & Oncology
- 陳彥豪 Division of Hematology & Oncology
- Yu-Li Su Division of Hematology & Oncology
- Tai-Jan Chiu Division of Hematology & Oncology
- 賴香蘭 Division of Hematology & Oncology
- Shau-Hsuan Li Division of Hematology & Oncology
- 劉建廷 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
Neuroendocrine Tumors
Objectives
CVM-1118 (TRX-818) is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by TaiRx, Inc. CVM-1118 is a potent anti-cancer agent in numerous human cancer cell lines. The safety of administrating CVM-1118 on human is evaluated from the phase 1 study. The objectives of the phase 2 study is to further investigate the efficacy of CVM-1118 for patients with advanced neuroendocrine tumors.
Test Drug
CVM-1118
Active Ingredient
CVM-1118
Dosage Form
Capsules
Dosage
50 mg
Endpoints
Primary Outcome Measures:
1. Time-to progression-free survival (PFS).
Secondary Outcome Measures:
1. Objective response rate (ORR).
2. Disease control rate (DCR).
3. Duration of overall response (DoR).
4. Time-to progression (TTP).
5. Time-to overall survival (OS).
6. Number of participants with treatment-related adverse events (AEs) as assessed by CTCAE v4.03.
7. Number of Participants With Abnormal baseline and out-of range Hematology Count by CTCAE v4.03.
8. Number of Participants With Abnormal Laboratory Values_Assessed the baseline and out-of range urinalysis test by CTCAE v4.03.
9. Number of Participants With Abnormal Laboratory Values_Assessed the baseline and out-of range coagulation test by CTCAE v4.03.
10. Number of Participants With Abnormal Vital Sign_Assessed the baseline and out-of-range vital signs_ body temperature by CTCAE v4.03.
11. Number of Participants With Abnormal Vital Sign_Assessed the baseline and out-of-range vital signs_ blood pressure by CTCAE v4.03.
12. Number of Participants With Abnormal Vital Sign_Assessed the baseline and out-of-range vital signs_ heart rate by CTCAE v4.03.
13. Number of Participants With Abnormal Vital Sign_Assessed the baseline and out-of-range vital signs_ respiratory rate by CTCAE v4.03.
14. Abnormalities in electrocardiography (ECG).
15. Maximum Plasma Concentration [Cmax] of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing.
16. Area Under the Curve [AUC] of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing.
17. Pharmacodynamics analysis for the relationship of Cmax and PFS.
18. Pharmacodynamics analysis for the relationship of AUC and PFS.
19. Pharmacodynamics analysis for the relationship of AUC and AE.
20. Pharmacodynamics analysis for the relationship of Cmax and AE.
1. Time-to progression-free survival (PFS).
Secondary Outcome Measures:
1. Objective response rate (ORR).
2. Disease control rate (DCR).
3. Duration of overall response (DoR).
4. Time-to progression (TTP).
5. Time-to overall survival (OS).
6. Number of participants with treatment-related adverse events (AEs) as assessed by CTCAE v4.03.
7. Number of Participants With Abnormal baseline and out-of range Hematology Count by CTCAE v4.03.
8. Number of Participants With Abnormal Laboratory Values_Assessed the baseline and out-of range urinalysis test by CTCAE v4.03.
9. Number of Participants With Abnormal Laboratory Values_Assessed the baseline and out-of range coagulation test by CTCAE v4.03.
10. Number of Participants With Abnormal Vital Sign_Assessed the baseline and out-of-range vital signs_ body temperature by CTCAE v4.03.
11. Number of Participants With Abnormal Vital Sign_Assessed the baseline and out-of-range vital signs_ blood pressure by CTCAE v4.03.
12. Number of Participants With Abnormal Vital Sign_Assessed the baseline and out-of-range vital signs_ heart rate by CTCAE v4.03.
13. Number of Participants With Abnormal Vital Sign_Assessed the baseline and out-of-range vital signs_ respiratory rate by CTCAE v4.03.
14. Abnormalities in electrocardiography (ECG).
15. Maximum Plasma Concentration [Cmax] of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing.
16. Area Under the Curve [AUC] of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing.
17. Pharmacodynamics analysis for the relationship of Cmax and PFS.
18. Pharmacodynamics analysis for the relationship of AUC and PFS.
19. Pharmacodynamics analysis for the relationship of AUC and AE.
20. Pharmacodynamics analysis for the relationship of Cmax and AE.
Inclution Criteria
1. [Tumor eligibility] Histologically or cytologically confirmed advanced (unresectable and/or metastatic) neuroendocrine tumors that are well-differentiated, low or intermediate grade (WHO Grade 1 or 2) of pancreatic or gastrointestinal, or low/ intermediate grade of lung origin, that are refractory to standard of care therapy, or for whom no standard of care therapy is available.
2. Patients must have measurable or evaluable disease as per RECIST criteria v1.1. Target lesions that have been previously irradiated will not be considered measurable (lesion) unless increase in size is observed following completion of radiation therapy.
3. Patients must have documented progressive disease within 6 months prior enrollment after prior therapy.
4. Patients who are on therapy with a somatostatin analog are eligible but progressive disease must be demonstrated subsequent to establishment for at least 3 months of a stable dose.
5. Male or female, 20 years of age or older.
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
7. Resolution of all acute toxic effects of prior therapy or surgical procedures to Grade 1 (except alopecia).
8. Adequate organ function as defined by the following criteria:
(1) Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≦ 3 x upper limit of normal (ULN), or AST and ALT ≦ 5 x ULN if liver function abnormalities are due to underlying malignancy
(2) Total serum bilirubin ≦ 1.5 x ULN (except for patients with documented Gilbert's syndrome)
(3) Absolute neutrophil count (ANC) ≧ 1500/µL
(4) Platelets ≧ 90,000/µL
(5) Hemoglobin ≧ 9.0 g/dL
(6) Serum creatinine ≦ 2.0 x ULN or creatinine clearance of ≧ 50 mL/min
9. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
2. Patients must have measurable or evaluable disease as per RECIST criteria v1.1. Target lesions that have been previously irradiated will not be considered measurable (lesion) unless increase in size is observed following completion of radiation therapy.
3. Patients must have documented progressive disease within 6 months prior enrollment after prior therapy.
4. Patients who are on therapy with a somatostatin analog are eligible but progressive disease must be demonstrated subsequent to establishment for at least 3 months of a stable dose.
5. Male or female, 20 years of age or older.
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
7. Resolution of all acute toxic effects of prior therapy or surgical procedures to Grade 1 (except alopecia).
8. Adequate organ function as defined by the following criteria:
(1) Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≦ 3 x upper limit of normal (ULN), or AST and ALT ≦ 5 x ULN if liver function abnormalities are due to underlying malignancy
(2) Total serum bilirubin ≦ 1.5 x ULN (except for patients with documented Gilbert's syndrome)
(3) Absolute neutrophil count (ANC) ≧ 1500/µL
(4) Platelets ≧ 90,000/µL
(5) Hemoglobin ≧ 9.0 g/dL
(6) Serum creatinine ≦ 2.0 x ULN or creatinine clearance of ≧ 50 mL/min
9. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion Criteria
1. Poorly differentiated neuroendocrine carcinoma, or high grade neuroendocrine tumor.
2. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
3. Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of starting study treatment.
4. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
5. Current treatment on another clinical trial.
6. Patients who are using other investigational agents or who had received investigational drugs within 4 weeks prior to study enrollment.
7. Brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease unless appropriately treated and neurologically stable for at least 4 weeks.
8. Any of the following within the 12 months prior to starting study treatment:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack; within 6 months prior to starting study treatment for pulmonary embolus. However, upon agreement between the investigator and sponsor, the 6-month post-event-free period for a patient with a pulmonary embolus can be waived if due to advanced cancer. Appropriate treatment with anticoagulants is permitted.
9. Hypertension that cannot be controlled by medications (> 160/100 mmHg despite optimal medical therapy).
10. Current treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
11. Known history of human immunodeficiency virus (HIV) seropositivity and/or is receiving anti-retroviral therapy.
12. Hepatitis B virus (HBV) or hepatitis C virus (HCV) with evidence of chronic active disease or receiving/requiring antiviral therapy.
13. History of receiving organ transplantation or immune disorders that require continuous immunosuppressant agent therapy.
14. Pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal or must agree to the use of effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the Investigator or a designated associate.
15. Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that would impart, in the judgment of the investigator and/or Sponsor, excess risk associated with study participation or study drug administration, which would make the patient inappropriate for entry into this study.
2. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
3. Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of starting study treatment.
4. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
5. Current treatment on another clinical trial.
6. Patients who are using other investigational agents or who had received investigational drugs within 4 weeks prior to study enrollment.
7. Brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease unless appropriately treated and neurologically stable for at least 4 weeks.
8. Any of the following within the 12 months prior to starting study treatment:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack; within 6 months prior to starting study treatment for pulmonary embolus. However, upon agreement between the investigator and sponsor, the 6-month post-event-free period for a patient with a pulmonary embolus can be waived if due to advanced cancer. Appropriate treatment with anticoagulants is permitted.
9. Hypertension that cannot be controlled by medications (> 160/100 mmHg despite optimal medical therapy).
10. Current treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
11. Known history of human immunodeficiency virus (HIV) seropositivity and/or is receiving anti-retroviral therapy.
12. Hepatitis B virus (HBV) or hepatitis C virus (HCV) with evidence of chronic active disease or receiving/requiring antiviral therapy.
13. History of receiving organ transplantation or immune disorders that require continuous immunosuppressant agent therapy.
14. Pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal or must agree to the use of effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the Investigator or a designated associate.
15. Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that would impart, in the judgment of the investigator and/or Sponsor, excess risk associated with study participation or study drug administration, which would make the patient inappropriate for entry into this study.
The Estimated Number of Participants
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Taiwan
43 participants
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Global
43 participants
