Back to resultsTAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma
Primary Purpose
Pancreas Cancer
Status
Recruiting
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
TAS 102
Sponsored by
About this trial
This is an interventional treatment trial for Pancreas Cancer focused on measuring Pancreatic Adenocarcinoma, TAS-102
Eligibility Criteria
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.
Sites / Locations
- Department of Clinical Oncology, HKURecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TAS-102
Arm Description
Single group assignment of TAS-102 in Patients with Advanced, Refractory Pancreatic Adenocarcinoma
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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
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
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.
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
Duration of response (DoR)
DoR is the time from documentation of tumor response to radiographically documented disease progression
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
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
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)
Full Information
NCT ID
NCT04923529
First Posted
June 6, 2021
Last Updated
July 13, 2022
Sponsor
The University of Hong Kong
Collaborators
Taiho Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04923529
Brief Title
TAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma
Official Title
Phase II Trial of TAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Taiho Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer
Keywords
Pancreatic Adenocarcinoma, TAS-102
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAS-102
Arm Type
Experimental
Arm Description
Single group assignment of TAS-102 in Patients with Advanced, Refractory Pancreatic Adenocarcinoma
Intervention Type
Drug
Intervention Name(s)
TAS 102
Intervention Description
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
Primary Outcome Measure Information:
Title
16-week progression-free survival (PFS) rate
Description
The percentage of study population alive and without progression (according to RECIST 1.1) at 16 weeks from the date of informed consent
Time Frame
From the date of screening to radiographically documented progression according to mRECIST 1.1, assessed up to 16 weeks
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
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.
Time Frame
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
Title
Time to progression (TTP)
Description
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
Time Frame
from the date of first study treatment to radiographically documented progression according to mRECIST 1.1, assessed up to 3 years
Title
Overall survival (OS)
Description
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
Time Frame
from the date of first study treatment to the date of death from any cause, assessed up to 5 years
Title
Objective response rate (ORR)
Description
The percentage of patients with radiologically complete or partial response as determined by the Investigator according to RECIST version 1.1.
Time Frame
From the date of screening to radiographically documented progression according to mRECIST 1.1, assessed up to 16 weeks
Title
Disease control rate (DCR)
Description
The percentage of patients with radiologically complete response, partial response, or stable disease as determined by the Investigators according to RECIST version 1.1
Time Frame
from the date of screening to radiographically documented progression according to mRECIST 1.1, assessed up to 16 weeks
Title
Duration of response (DoR)
Description
DoR is the time from documentation of tumor response to radiographically documented disease progression
Time Frame
from the date of screening to radiographically documented progression according to mRECIST 1.1, assessed up to 16 weeks
Title
Time to deterioration of ECOG performance status
Description
Time from date of informed consent until the first date on which ECOG performance status score of 2 or higher was recorded
Time Frame
from the date of screening to radiographically documented progression according to mRECIST 1.1, an average of 1 years
Title
Time to deterioration of quality of life
Description
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
Time Frame
from the date of screening to radiographically documented progression according to mRECIST 1.1, an average of 3 years
Title
Safety outcome measures
Description
Incidence, nature, and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE 5)
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chi Leung Chiang, FRCR
Phone
+85222554352
Email
chiangcl@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi Leung Chiang, FRCR
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Oncology, HKU
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi Leung Chiang, FRCR
Phone
+852 2255 4352
First Name & Middle Initial & Last Name & Degree
Chi Leung Chiang, FRCR
12. IPD Sharing Statement
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TAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma
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