TAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma

July 13, 2022 updated by: Dr. Chi-Leung Chiang, The University of Hong Kong

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chi Leung Chiang, FRCR
  • Phone Number: +85222554352
  • Email: chiangcl@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Department of Clinical Oncology, HKU
        • Contact:
          • Chi Leung Chiang, FRCR
          • Phone Number: +852 2255 4352
        • Principal Investigator:
          • Chi Leung Chiang, FRCR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
16-week progression-free survival (PFS) rate
Time Frame: From the date of screening to radiographically documented progression according to mRECIST 1.1, assessed up to 16 weeks
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)
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
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)
Time Frame: from the date of first study treatment to radiographically documented progression according to mRECIST 1.1, assessed up to 3 years
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)
Time Frame: from the date of first study treatment to the date of death from any cause, assessed up to 5 years
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)
Time Frame: From the date of screening to radiographically documented progression according to mRECIST 1.1, assessed up to 16 weeks
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)
Time Frame: from the date of screening to radiographically documented progression according to mRECIST 1.1, assessed up to 16 weeks
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)
Time Frame: from the date of screening to radiographically documented progression according to mRECIST 1.1, assessed up to 16 weeks
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 Frame: from the date of screening to radiographically documented progression according to mRECIST 1.1, an average of 1 years
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
Time Frame: from the date of screening to radiographically documented progression according to mRECIST 1.1, an average of 3 years
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Taiho Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

May 31, 2023

Study Completion (Anticipated)

November 30, 2023

Study Registration Dates

First Submitted

June 6, 2021

First Submitted That Met QC Criteria

June 6, 2021

First Posted (Actual)

June 11, 2021

Study Record Updates

Last Update Posted (Actual)

July 18, 2022

Last Update Submitted That Met QC Criteria

July 13, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 20-711

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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