TAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma

Study Overview
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Brief Summary
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This study is a prospective phase II, single arm mono-institutional study conducted in Queen Mary Hospital (Hong Kong) assessing the efficacy and safety of TAS 102 in advanced or metastatic pancreatic cancer patients.

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).

Official Title
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Phase II Trial of TAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma

Conditions
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Pancreas Cancer

Intervention / Treatment
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* Drug: TAS 102


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological or cytological confirmed advanced or metastatic pancreatic cancer Measurable disease according to the RECIST criteria (version 1.1) for the evaluation of measurable disease Documented progression after one or more lines of systemic chemotherapy For the treatment of advanced or metastatic disease Within 6 months after completion of neo-adjuvant therapy or adjuvant therapy Age ≥ 18 years Eastern Cooperative Oncology Group (ECOG) performance 0-1 Written informed consent obtained for clinical trial participation and providing archival tumor tissue, if available Exclusion Criteria: Has disease that is suitable for local therapy administrated with curative intent Has a serious illness or medical condition(s) including, but not limited to the following: Other concurrently active malignancies excluding malignancies that are disease free for more than 5 years or carcinoma-in-situ deemed cured by adequate treatment. Known brain metastasis or leptomeningeal metastasis. Active infection (i.e. body temperature ≥38°C due to infection). Ascites, pleural effusion or pericardial fluid requiring drainage in last 4 weeks. Intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or cerebrovascular disorder. Uncontrolled diabetes. Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV Gastrointestinal hemorrhage. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or hepatitis B or C. Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy. Psychiatric disease that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results. Has had treatment with any of the following within the specified time frame prior to study drug administration: Major surgery within prior 4 weeks. Any systemic therapy within prior 2 weeks. Any radiation within prior 2 weeks. Any investigational agent received within prior 4 weeks. Untreated active hepatitis B or hepatitis C infections. Has received TAS-102. 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). Is a pregnant or lactating female. Is inappropriate for entry into this study in the judgment of the Investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAS-102<br>Single group assignment of TAS-102 in Patients with Advanced, Refractory Pancreatic Adenocarcinoma | Drug: TAS 102<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 16-week progression-free survival (PFS) rate | The percentage of study population alive and without progression (according to RECIST 1.1) at 16 weeks from the date of informed consent | From the date of screening to radiographically documented progression according to mRECIST 1.1, assessed up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) | PFS is measured from the date of informed consent to radiographically documented progression according to RECIST 1.1 or death from any cause (whichever occurs first). Participants alive and without disease progression or lost to follow up will be censored at the date of their last radiographic assessment. | from the date of first study treatment to radiographically documented progression according to mRECIST 1.1 or death from any cause, whichever occurs first, assessed up to 3 years | 
| Time to progression (TTP) | TTP is measured from the date of informed consent to radiographically documented progression according to RECIST 1.1. Participants death and without disease progression, alive without disease progression, or lost to follow-up will be censored at the date of their last radiographic assessment | from the date of first study treatment to radiographically documented progression according to mRECIST 1.1, assessed up to 3 years | 
| Overall survival (OS) | OS is measured from date of informed consent to the date of death from any cause. Participants alive or lost to follow-up will be censored at the date of their last radiographic assessment | from the date of first study treatment to the date of death from any cause, assessed up to 5 years | 
| Objective response rate (ORR) | The percentage of patients with radiologically complete or partial response as determined by the Investigator according to RECIST version 1.1. | From the date of screening to radiographically documented progression according to mRECIST 1.1, assessed up to 16 weeks | 
| Disease control rate (DCR) | The percentage of patients with radiologically complete response, partial response, or stable disease as determined by the Investigators according to RECIST version 1.1 | from the date of screening to radiographically documented progression according to mRECIST 1.1, assessed up to 16 weeks | 
| Duration of response (DoR) | DoR is the time from documentation of tumor response to radiographically documented disease progression | from the date of screening to radiographically documented progression according to mRECIST 1.1, assessed up to 16 weeks | 
| Time to deterioration of ECOG performance status | Time from date of informed consent until the first date on which ECOG performance status score of 2 or higher was recorded | from the date of screening to radiographically documented progression according to mRECIST 1.1, an average of 1 years | 
| Time to deterioration of quality of life | Decrease from baseline of 10 points or more on the EORTC QLQ-C30 maintained for two consecutive assessments or a decrease of 10 points or more in one assessment followed by death from any cause within 3 weeks | from the date of screening to radiographically documented progression according to mRECIST 1.1, an average of 3 years | 
| Safety outcome measures | Incidence, nature, and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE 5) | from the date of first study treatment to radiographically documented progression according to mRECIST 1.1 or death from any cause, whichever occurs first, assessed up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic Adenocarcinoma, TAS-102