Trial Outcomes & Findings for TAS-102 and Irinotecan in 2L+ Gastric and Gastroesophageal Adenocarcinoma (NCT NCT04074343)

Last Updated: 2024-02-02

Results Overview

This is defined as the percentage of subjects who are free of progression 6 months after study treatment start. Progression is defined as death, radiographic progression or clinical deterioration attributed to disease progression as judged by an investigator. Radiographic progression is defined using the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of diameters of target lesions and an absolute increase of an least 5 mm and/or appearance of new lesions.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

20 participants

Primary outcome timeframe

6 Months

Results posted on

2024-02-02

Participant Flow

Participant milestones

Participant milestones
Measure	TAS-102 and Irinotecan Patients receive TAS-102 25 mg/m2 PO twice daily on days 1-5 and and Irinotecan 180mg/m2 IV on day 1 every 14 days. TAS-102: Given PO Irinotecan: Given IV
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TAS-102 and Irinotecan in 2L+ Gastric and Gastroesophageal Adenocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TAS-102 and Irinotecan n=20 Participants Patients receive TAS-102 25 mg/m2 PO twice daily on days 1-5 and and Irinotecan 180mg/m2 IV on day 1 every 14 days. TAS-102: Given PO Irinotecan: Given IV
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	10 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	6 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

Outcome measures

Outcome measures
Measure	TAS-102 and Irinotecan n=20 Participants Patients receive TAS-102 25 mg/m2 PO twice daily on days 1-5 and and Irinotecan 180mg/m2 IV on day 1 every 14 days. TAS-102: Given PO Irinotecan: Given IV
Percentage of Participants With Progression-free Survival at 6 Months	40 percent of participants Interval 19.3 to 60.0

SECONDARY outcome

Timeframe: 8 Weeks

To evaluate the tolerability of administering TAS-102 in combination with Irinotecan in patients with advanced recurrent or unresectable gastric and gastroesophageal adenocarcinoma for the first 2 cycles of study treatment. Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0.

Outcome measures

Outcome measures
Measure	TAS-102 and Irinotecan n=20 Participants Patients receive TAS-102 25 mg/m2 PO twice daily on days 1-5 and and Irinotecan 180mg/m2 IV on day 1 every 14 days. TAS-102: Given PO Irinotecan: Given IV
Number of Participants With Grade 3-5 Adverse Events	8 Participants

SECONDARY outcome

Timeframe: From date of registration until first date of disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.

To assess the objective response rate to the combination of TAS-102 and Irinotecan. Objective response rate (ORR) is defined as confirmed complete response (CR) and partial response (PR). Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. ORR = CR + PR

Outcome measures

Outcome measures
Measure	TAS-102 and Irinotecan n=17 Participants Patients receive TAS-102 25 mg/m2 PO twice daily on days 1-5 and and Irinotecan 180mg/m2 IV on day 1 every 14 days. TAS-102: Given PO Irinotecan: Given IV
Objective Response Rate as Assessed by RECIST v1.1 Criteria of Patients Who Received TAS-102 and Irinotecan	0 Participants

SECONDARY outcome

Timeframe: From date of registration for up to 18 months after last patient is enrolled or until death from any cause, whichever came first.

To evaluate overall survival in patients with advanced recurrent or unresectable and gastroesophageal adenocarcinoma treated with this combination of TAS-102 and Irinotecan.

Outcome measures

Outcome measures
Measure	TAS-102 and Irinotecan n=20 Participants Patients receive TAS-102 25 mg/m2 PO twice daily on days 1-5 and and Irinotecan 180mg/m2 IV on day 1 every 14 days. TAS-102: Given PO Irinotecan: Given IV
Overall Survival of Patients of Patients Who Received TAS-102 and Irinotecan	12.2 Months Interval 5.9 to 18.6

Adverse Events

TAS-102 and Irinotecan

Serious events: 2 serious events

Other events: 20 other events

Deaths: 17 deaths

Serious adverse events

Serious adverse events
Measure	TAS-102 and Irinotecan n=20 participants at risk Patients receive TAS-102 25 mg/m2 PO twice daily on days 1-5 and and Irinotecan 180mg/m2 IV on day 1 every 14 days. TAS-102: Given PO Irinotecan: Given IV
Blood and lymphatic system disorders Febrile Neutropenia	5.0% 1/20 • From date of registration until treatment completion, disease progression or other reasons for removal from protocol treatments, whichever came first, an average of 1 year. Toxicity was graded according to National Cancer Institute Common Terminology Criteria of Adverse Events, version 5.0. Safety was assessed through adverse event monitoring, physical examinations, vital signs and clinical laboratory tests before each dosing.
Vascular disorders Hypotension	5.0% 1/20 • From date of registration until treatment completion, disease progression or other reasons for removal from protocol treatments, whichever came first, an average of 1 year. Toxicity was graded according to National Cancer Institute Common Terminology Criteria of Adverse Events, version 5.0. Safety was assessed through adverse event monitoring, physical examinations, vital signs and clinical laboratory tests before each dosing.

Other adverse events

Other adverse events
Measure	TAS-102 and Irinotecan n=20 participants at risk Patients receive TAS-102 25 mg/m2 PO twice daily on days 1-5 and and Irinotecan 180mg/m2 IV on day 1 every 14 days. TAS-102: Given PO Irinotecan: Given IV
Blood and lymphatic system disorders Hypokalemia	10.0% 2/20 • From date of registration until treatment completion, disease progression or other reasons for removal from protocol treatments, whichever came first, an average of 1 year. Toxicity was graded according to National Cancer Institute Common Terminology Criteria of Adverse Events, version 5.0. Safety was assessed through adverse event monitoring, physical examinations, vital signs and clinical laboratory tests before each dosing.
Blood and lymphatic system disorders White blood cell decreased	10.0% 2/20 • From date of registration until treatment completion, disease progression or other reasons for removal from protocol treatments, whichever came first, an average of 1 year. Toxicity was graded according to National Cancer Institute Common Terminology Criteria of Adverse Events, version 5.0. Safety was assessed through adverse event monitoring, physical examinations, vital signs and clinical laboratory tests before each dosing.
General disorders Nausea	70.0% 14/20 • From date of registration until treatment completion, disease progression or other reasons for removal from protocol treatments, whichever came first, an average of 1 year. Toxicity was graded according to National Cancer Institute Common Terminology Criteria of Adverse Events, version 5.0. Safety was assessed through adverse event monitoring, physical examinations, vital signs and clinical laboratory tests before each dosing.
Gastrointestinal disorders Diarrhea	50.0% 10/20 • From date of registration until treatment completion, disease progression or other reasons for removal from protocol treatments, whichever came first, an average of 1 year. Toxicity was graded according to National Cancer Institute Common Terminology Criteria of Adverse Events, version 5.0. Safety was assessed through adverse event monitoring, physical examinations, vital signs and clinical laboratory tests before each dosing.
General disorders Fatigue	50.0% 10/20 • From date of registration until treatment completion, disease progression or other reasons for removal from protocol treatments, whichever came first, an average of 1 year. Toxicity was graded according to National Cancer Institute Common Terminology Criteria of Adverse Events, version 5.0. Safety was assessed through adverse event monitoring, physical examinations, vital signs and clinical laboratory tests before each dosing.
General disorders Abdominal Pain	35.0% 7/20 • From date of registration until treatment completion, disease progression or other reasons for removal from protocol treatments, whichever came first, an average of 1 year. Toxicity was graded according to National Cancer Institute Common Terminology Criteria of Adverse Events, version 5.0. Safety was assessed through adverse event monitoring, physical examinations, vital signs and clinical laboratory tests before each dosing.
General disorders Vomiting	30.0% 6/20 • From date of registration until treatment completion, disease progression or other reasons for removal from protocol treatments, whichever came first, an average of 1 year. Toxicity was graded according to National Cancer Institute Common Terminology Criteria of Adverse Events, version 5.0. Safety was assessed through adverse event monitoring, physical examinations, vital signs and clinical laboratory tests before each dosing.
Nervous system disorders Anorexia	30.0% 6/20 • From date of registration until treatment completion, disease progression or other reasons for removal from protocol treatments, whichever came first, an average of 1 year. Toxicity was graded according to National Cancer Institute Common Terminology Criteria of Adverse Events, version 5.0. Safety was assessed through adverse event monitoring, physical examinations, vital signs and clinical laboratory tests before each dosing.
Immune system disorders Alopecia	20.0% 4/20 • From date of registration until treatment completion, disease progression or other reasons for removal from protocol treatments, whichever came first, an average of 1 year. Toxicity was graded according to National Cancer Institute Common Terminology Criteria of Adverse Events, version 5.0. Safety was assessed through adverse event monitoring, physical examinations, vital signs and clinical laboratory tests before each dosing.
Gastrointestinal disorders Constipation	15.0% 3/20 • From date of registration until treatment completion, disease progression or other reasons for removal from protocol treatments, whichever came first, an average of 1 year. Toxicity was graded according to National Cancer Institute Common Terminology Criteria of Adverse Events, version 5.0. Safety was assessed through adverse event monitoring, physical examinations, vital signs and clinical laboratory tests before each dosing.
General disorders Headache	15.0% 3/20 • From date of registration until treatment completion, disease progression or other reasons for removal from protocol treatments, whichever came first, an average of 1 year. Toxicity was graded according to National Cancer Institute Common Terminology Criteria of Adverse Events, version 5.0. Safety was assessed through adverse event monitoring, physical examinations, vital signs and clinical laboratory tests before each dosing.
General disorders Mucositis oral	10.0% 2/20 • From date of registration until treatment completion, disease progression or other reasons for removal from protocol treatments, whichever came first, an average of 1 year. Toxicity was graded according to National Cancer Institute Common Terminology Criteria of Adverse Events, version 5.0. Safety was assessed through adverse event monitoring, physical examinations, vital signs and clinical laboratory tests before each dosing.
Vascular disorders Hypotention	10.0% 2/20 • From date of registration until treatment completion, disease progression or other reasons for removal from protocol treatments, whichever came first, an average of 1 year. Toxicity was graded according to National Cancer Institute Common Terminology Criteria of Adverse Events, version 5.0. Safety was assessed through adverse event monitoring, physical examinations, vital signs and clinical laboratory tests before each dosing.
Blood and lymphatic system disorders Neutrophil count decreased	30.0% 6/20 • From date of registration until treatment completion, disease progression or other reasons for removal from protocol treatments, whichever came first, an average of 1 year. Toxicity was graded according to National Cancer Institute Common Terminology Criteria of Adverse Events, version 5.0. Safety was assessed through adverse event monitoring, physical examinations, vital signs and clinical laboratory tests before each dosing.
Blood and lymphatic system disorders Anemia	25.0% 5/20 • From date of registration until treatment completion, disease progression or other reasons for removal from protocol treatments, whichever came first, an average of 1 year. Toxicity was graded according to National Cancer Institute Common Terminology Criteria of Adverse Events, version 5.0. Safety was assessed through adverse event monitoring, physical examinations, vital signs and clinical laboratory tests before each dosing.

Additional Information

Chao Family Comprehensive Cancer Center, University of California, Irvine

Phone: 1-877-UC-STUDY

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place