Clinical Trials List
2013-10-01 - 2020-07-31
Phase III
Terminated17
ICD-10C25.9
Malignant neoplasm of pancreas, unspecified
A Phase III, Open-label, Randomized Study of the Combination Therapy With NC-6004 and Gemcitabine Versus Gemcitabine Alone in Patients With Locally Advanced or Metastatic Pancreatic Cancer
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Trial Applicant
Orient EuroPharma Co., Ltd.
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Sponsor
Orient Europharma Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/19
Investigators and Locations
Co-Principal Investigator
- Ming-Huang Chen Division of Hematology & Oncology
- Rheun-Chuan Lee Division of Radiology
- Yee Chao Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- SHIH-HUNG YANG Division of Hematology & Oncology
- 林育麟 Division of Hematology & Oncology
- 章明珠 Division of General Internal Medicine
- 陳俊男 Division of Otolaryngology
- 張毓廷 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 王蒼恩 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 陳宇欽 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Tsu-Yi Chao Division of Hematology & Oncology
- Jacqueline Whang-Peng Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- JENG-FONG CHIOU Division of Radiation Therapy
- 夏和雄 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 饒坤銘 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Li-Yuan Bai Division of Hematology & Oncology
- Ming-Yu Lien Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Tsai-Sheng Yang Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 曹朝榮 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 鍾奇峰 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 黃健泰 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Kuan-Der Lee Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 張肇松 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
Taiwan National PI
Co-Principal Investigator
- Li-Tzong Chen Division of Hematology & Oncology
- Chia-Jui Yen Division of Hematology & Oncology
- Yan-Shen Shan Division of General Surgery
The Actual Total Number of Participants Enrolled
16 Completed
Co-Principal Investigator
- 王蒼恩 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Overall survival (OS) [ Time Frame: 3.5 years ]
Overall survival is defined as the time from the treatment initiation until death from any cause, and censored at the last follow up time.
Secondary Outcome Measures :
Progression free survival (PFS) [ Time Frame: 3.5 years ]
Progression free survival is defined as the time from the treatment initiation until progression or death, and censored at the last follow up time.
Response rate (RR) and disease control rate (DCR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria [ Time Frame: 3.5 years ]
Response rate is defined as counts and proportions of patients responding complete response or partial response within the duration of the study.
Disease control rate is defined as counts and proportions of patients responding complete response, partial response or progressive disease within the duration of the study.
Duration of response [ Time Frame: 3.5 years ]
Duration of overall response (DOR) will be measured from the time of initial response (CR or PR) until documented progression or death, and censored at last follow up time.
Duration of stable disease (DSD) will be measured from the time of initial stable disease (SD) until documented progression or death, and censored at last follow up time.
CA19-9 [ Time Frame: 3.5 years ]
CA19-9 values and changes from baseline will be summarized.
Quality of life (QoL) using EORTC QLQ-C30 [ Time Frame: 3.5 years ]
Quality of life (QoL) values and changes from baseline will be summarized.
Inclution Criteria
1. Male or female aged between 20 to 80 years (inclusive)
2. Unresectable, histologically or cytologically confirmed, locally advanced or metastatic pancreatic cancer (adenocarcinoma, adenosquamous carcinoma or poorly differentiated carcinoma)
3. Presence of at least one measurable tumor lesion (longest diameter ≥ 10 mm)
4. No prior systemic anti-cancer therapy* and radiotherapy** for advanced pancreatic cancer
* Patients with post-operative adjuvant chemotherapy other than platinum products (e.g. cisplatin, carboplatin and oxaliplatin, etc.) or radiotherapy or chemo-radiotherapy completed more than 6 months before recurrence will be eligible.
** Patients with prior palliative radiotherapy of < 20% bone marrow involvement prior to 6 months from screening will be eligible.
5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
6. Adequate organ function defined as:
3,000 cells/μL ≤ WBC ≤ 12,000 cells/μL
Absolute neutrophils count (ANC) ≥ 1,500 cells/μL
Platelets ≥ 100,000 cells/μL
Hemoglobin (Hb) ≥ 9.0 g/dL
Alanine amino transferase (ALT) and aspartate amino transferase (AST) ≤ 2.5 times the upper limit of normal (ULN) in patients with no demonstrable hepatic metastasis, or ≤ 5 x ULN in patients with hepatic metastasis
Serum bilirubin ≤ 1.5 x ULN in patients with no demonstrable hepatic metastasis and obstructive jaundice, or ≤ 2.5 x ULN in patients with hepatic metastasis or obstructive jaundice
Serum creatinine (SCr) ≤ 1.5 mg/dL and creatinine clearance (CrCl) ≥ 60 mL/min (from 24-hour urine test or Cockcroft-Gault formula)
Corrected serum calcium ≤ ULN
7. If fertile*, willing to use barrier contraception till 6 months after the end of treatment
* With the following exceptions: 1) pre-menopausal females with bilateral tubal ligation, bilateral oophorectomy or hysterectomy; 2) post-menopausal women, defined as 12 months of spontaneous amenorrhea; 3) males with vasectomy.
8. Willing and able to comply with study procedures and provide written informed consent
Exclusion Criteria
Active concomitant malignancy or history of other cancer except carcinoma in situ of cervical squamous cell carcinoma, stage I colon cancer or other malignance that has remained disease-free for more than 3 years after curative intervention
Metastasis to the central nervous system or brain
Evidence of hearing impaired ≥ Grade 2 as assessed by pure tone audiometry or other neurotoxicity ≥ Grade 2
* Patients with age-associated hearing loss at the high frequencies that, in the judgment of the investigator, would not interfere significantly with patient's safety or study assessments will be eligible to enroll.
Patient with pulmonary fibrosis or interstitial pneumonia
Marked pleural effusion or ascites above Grade 2
Patient with known HIV infection
Patient with active hepatitis B, hepatitis C or any other ongoing severe infections
Patient with severe mental disorder
As judged by the investigator, any evidence of significant laboratory findings or severe/uncontrolled clinical disorders (e.g. dementia, myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, active cardiomyopathy, unstable arrhythmia, and other unstable or uncompensated respiratory, cardiac, hepatic, renal and/or infectious disease)
Patient with known hypersensitivity to Pt compounds
Known severe drug hypersensitivity
Treatment with a non-approved or investigational product within 30 days before Day 1 of study treatment
Alcoholic liver disease* or liver disease with obvious clinical symptom or sign
* the investigator should judge from medical examination by interview and laboratory test including γ-GTP, AST and ALT
Daily Alcohol consumption within 6 months before the screening as an average weekly intake of >21 units (168 g of pure alcohol) or an average daily intake of >3 units (24 g of pure alcohol) for males / an average weekly intake of >14 units (112 g of pure alcohol) or an average daily intake of >2 units (16 g of pure alcohol) for females.
Kind of Alcohol Alcohol Percentage mL per 1 unit =8 g of pure alcohol
Beer 5 % 200 mL
Whiskey/Brandy 40 % 25 mL
Wine 12 % approx. 83 mL
Sake 15 % approx. 67 mL
Distilled spirit 25 % 40 mL
Kaoliang 50 % 20 mL
Patient with uncontrolled diabetes
Radiotherapy within 6 months before screening
Experienced Abdominal Radiotherapy
Experienced treatment of Gemtuzumab ozogamicin
Patient with autoimmune hepatitis or idiopathic thrombocytopenic purpura (ITP)
Observation of "attenuated or reversed hepatic venous portal blood flow*" was confirmed by doppler ultrasonography or CT (recommend evaluation in arterial phase, portal-venous phase and equilibrium phase) of the liver * On doppler ultrasonography of right and left branch of portal vein, blood flow is measured as about 0 mL/min or between plus and minus, which indicate obvious blood flow obstruction
The Estimated Number of Participants
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Taiwan
160 participants
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Global
310 participants
