TAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma
NCT ID: NCT04923529
Last Updated: 2025-07-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
28 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-03-01
Study Completion Date
2024-12-31
Brief Summary
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This is a prospective phase II, single arm clinical trial conducted in Queen Mary Hospital (Hong Kong) assessing the efficacy and safety of TAS-102 in advanced or metastatic pancreatic cancer patients.
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Detailed Description
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All the patients must be registered with the Investigator(s) prior to initiation of treatment. The registration desk will confirm all eligibility criteria and obtain essential information (including patient number).
Conditions
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Pancreas Cancer
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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TAS-102
Single group assignment of TAS-102 in Patients with Advanced, Refractory Pancreatic Adenocarcinoma
Group Type
EXPERIMENTAL
TAS 102
Intervention Type
DRUG
Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5.
Days 6 through 7: Recovery
Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12.
Days 13 through 28: Recovery
Interventions
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TAS 102
Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5.
Days 6 through 7: Recovery
Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12.
Days 13 through 28: Recovery
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. Histological or cytological confirmed advanced or metastatic pancreatic cancer
2. Measurable disease according to the RECIST criteria (version 1.1) for the evaluation of measurable disease
3. Documented progression after one or more lines of systemic chemotherapy
1. For the treatment of advanced or metastatic disease
2. Within 6 months after completion of neo-adjuvant therapy or adjuvant therapy
4. Age ≥ 18 years
5. Eastern Cooperative Oncology Group (ECOG) performance 0-1
6. Written informed consent obtained for clinical trial participation and providing archival tumor tissue, if available
7. Females of childbearing potential or non-sterilized male who are sexually active must use a highly effective method of contraception
8. Females of childbearing potential must have negative serum or urine pregnancy test
9. Have life expectancy ≥ 3 months
10. Adequate organ function as defined as:
1. Hemoglobin value of ≥9.0 g/dL.
2. Absolute neutrophil count of ≥1,500/mm3 (IU: ≥1.5 × 10\^9/L).
3. Platelet count ≥100,000/mm3 (IU: ≥100 × 10\^9/L).
4. Total serum bilirubin of ≤1.5 mg/dL (except for Grade 1 hyperbilirubinemia due solely to a medical diagnosis of Gilbert's syndrome).
5. Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤3.0 × upper limit of normal (ULN); if liver function abnormalities are due to underlying liver metastasis, AST and ALT ≤5 × ULN.
6. Serum creatinine of ≤1.5 mg/dL
2. Measurable disease according to the RECIST criteria (version 1.1) for the evaluation of measurable disease
3. Documented progression after one or more lines of systemic chemotherapy
1. For the treatment of advanced or metastatic disease
2. Within 6 months after completion of neo-adjuvant therapy or adjuvant therapy
4. Age ≥ 18 years
5. Eastern Cooperative Oncology Group (ECOG) performance 0-1
6. Written informed consent obtained for clinical trial participation and providing archival tumor tissue, if available
7. Females of childbearing potential or non-sterilized male who are sexually active must use a highly effective method of contraception
8. Females of childbearing potential must have negative serum or urine pregnancy test
9. Have life expectancy ≥ 3 months
10. Adequate organ function as defined as:
1. Hemoglobin value of ≥9.0 g/dL.
2. Absolute neutrophil count of ≥1,500/mm3 (IU: ≥1.5 × 10\^9/L).
3. Platelet count ≥100,000/mm3 (IU: ≥100 × 10\^9/L).
4. Total serum bilirubin of ≤1.5 mg/dL (except for Grade 1 hyperbilirubinemia due solely to a medical diagnosis of Gilbert's syndrome).
5. Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤3.0 × upper limit of normal (ULN); if liver function abnormalities are due to underlying liver metastasis, AST and ALT ≤5 × ULN.
6. Serum creatinine of ≤1.5 mg/dL
Exclusion Criteria
1. Has disease that is suitable for local therapy administrated with curative intent
2. Has a serious illness or medical condition(s) including, but not limited to the following:
1. Other concurrently active malignancies excluding malignancies that are disease free for more than 5 years or carcinoma-in-situ deemed cured by adequate treatment.
2. Known brain metastasis or leptomeningeal metastasis.
3. Active infection (i.e. body temperature ≥38°C due to infection).
4. Ascites, pleural effusion or pericardial fluid requiring drainage in last 4 weeks.
5. Intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or cerebrovascular disorder.
6. Uncontrolled diabetes.
7. Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV
8. Gastrointestinal hemorrhage.
9. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or hepatitis B or C.
10. Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy.
11. Psychiatric disease that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results.
3. Has had treatment with any of the following within the specified time frame prior to study drug administration:
1. Major surgery within prior 4 weeks.
2. Any systemic therapy within prior 2 weeks.
3. Any radiation within prior 2 weeks.
4. Any investigational agent received within prior 4 weeks.
4. Untreated active hepatitis B or hepatitis C infections.
5. Has received TAS-102.
6. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation and platinum-induced neurotoxicity).
7. Is a pregnant or lactating female.
8. Is inappropriate for entry into this study in the judgment of the Investigator.
2. Has a serious illness or medical condition(s) including, but not limited to the following:
1. Other concurrently active malignancies excluding malignancies that are disease free for more than 5 years or carcinoma-in-situ deemed cured by adequate treatment.
2. Known brain metastasis or leptomeningeal metastasis.
3. Active infection (i.e. body temperature ≥38°C due to infection).
4. Ascites, pleural effusion or pericardial fluid requiring drainage in last 4 weeks.
5. Intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or cerebrovascular disorder.
6. Uncontrolled diabetes.
7. Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV
8. Gastrointestinal hemorrhage.
9. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or hepatitis B or C.
10. Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy.
11. Psychiatric disease that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results.
3. Has had treatment with any of the following within the specified time frame prior to study drug administration:
1. Major surgery within prior 4 weeks.
2. Any systemic therapy within prior 2 weeks.
3. Any radiation within prior 2 weeks.
4. Any investigational agent received within prior 4 weeks.
4. Untreated active hepatitis B or hepatitis C infections.
5. Has received TAS-102.
6. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation and platinum-induced neurotoxicity).
7. Is a pregnant or lactating female.
8. Is inappropriate for entry into this study in the judgment of the Investigator.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Taiho Pharmaceutical Co., Ltd.
INDUSTRY
Sponsor Role
collaborator
The University of Hong Kong
OTHER
Sponsor Role
lead
Responsible Party
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Dr. Chi-Leung Chiang
Clinical Assistant Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Chi Leung Chiang, FRCR
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
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Department of Clinical Oncology, HKU
Hong Kong, , Hong Kong
Site Status
Countries
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Hong Kong
References
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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UW 20-711
Identifier Type: -
Identifier Source: org_study_id
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Nivolumab and All-trans Retinoic Acid for Pancreatic Cancer
NCT05482451
ACTIVE_NOT_RECRUITING
EARLY_PHASE1
Tislelizumab With Anlotinib and Chemotherapy for Second-line Treatment of Pancreatic Cancer
NCT05681390
UNKNOWN
PHASE2
A Phase II Trial of CG 8020 and CG 2505 in Patients With Nonresectable or Metastatic Pancreatic Cancer
NCT00245362
COMPLETED
PHASE2
Autologous Cytokine-induced Killer Cells Combined Chemotherapy in Advanced Pancreatic Cancer
NCT03002831
TERMINATED
PHASE2
R115777 in Treating Patients Who Have Metastatic Pancreatic Cancer
NCT00005843
COMPLETED
PHASE2
Dasatinib in Treating Patients With Stage IV Pancreatic Cancer
NCT00544908
TERMINATED
PHASE2
Study of PEP02 as a Second Line Therapy for Metastatic Pancreatic Cancer
NCT00813163
COMPLETED
PHASE2
Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Gemcitabine Hydrochloride With or Without WEE1 Inhibitor AZD1775 in Treating Patients With Previously Untreated Pancreatic Cancer That Is Metastatic or Cannot Be Removed by Surgery
NCT02194829
COMPLETED
PHASE1/PHASE2
A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors
NCT03261947
COMPLETED
PHASE2
OMO-103 for the Treatment of Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma
NCT07089940
NOT_YET_RECRUITING
EARLY_PHASE1