TAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma

Pancreas Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04923529
• Other study ID #: UW 20-711
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: December 31, 2024
• Est. primary completion date: March 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Department of Clinical Oncology, HKU	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Hong Kong, 

References & Publications (36)

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of Study-Related Adverse Events [Safety and Tolerability]	Incidence, nature, and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE 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