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

NCT ID: NCT04074343

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-26
• Study Completion Date: 2022-07-21

Brief Summary

This is a phase Ib single-arm, open-label clinical trial determining the feasibility and efficacy of TAS-102 and irinotecan in subjects with advanced gastric and gastroesophageal adenocarcinoma. These are subjects who are not candidates for curative treatments and who have received at least one prior line of chemotherapy with a fluoropyrimidine and platinum agent.

Detailed Description

Treatment on study will be administered in 14 day cycles.

Conditions

Gastric Adenocarcinoma; GastroEsophageal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

TAS-102

Intervention Type: DRUG

Given PO

Irinotecan

Intervention Type: DRUG

Given IV

Interventions

TAS-102

Given PO

Intervention Type: DRUG

Irinotecan

Given IV

Intervention Type: DRUG

Other Intervention Names

LONSURF; trifluoridine and tipiracil; CAMPTOSAR; CPT-11

Eligibility Criteria

Inclusion Criteria

• Patients must have histologically or cytologically confirmed gastric or gastroesophageal adenocarcinoma
• Must have locally advanced, recurrent, or metastatic disease not amenable to curative intent surgery.
• Must have progressed, or not tolerated, at least one line of treatment with a platinum and/or fluoropyrimidine containing regimen. At least one cycle of combination chemotherapy including a platinum (oxaliplatin, cisplatin, carboplatin) and/or fluoropyrimidine (capecitabine or 5-Fluorouracil) based regimen for advanced disease. Combination regimens with platinum/fluoropyrimidine containing a taxane and or a checkpoint inhibitor are allowed. Patients progressing within six months of perioperative chemotherapy or definitive chemoradiation for localized disease are eligible. Patients who have exhausted all other standard of care options are also eligible.
• Age ≥ 18 years
• Performance status: ECOG performance status ≤2
• Life expectancy of greater than 3 months
• Adequate organ and marrow function as defined below:

1. leukocytes : ≥ 3,000/mcL

2. absolute neutrophil count: ≥ 1,500/mcL

3. platelets: ≥ 80,000/mcl

4. total bilirubin: within normal institutional limits

5. AST(SGOT)/ALT(SPGT): ≤ 3 X institutional upper limit of normal or ≤ 5 X if liver metastases are present

6. creatinine: < 1.5 X upper limit of normal

• The effects of TAS-102 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because topoisomerase inhibitors are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

1. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

1. Has not undergone a hysterectomy or bilateral oophorectomy; or

2. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

• Ability to swallow tablets
• Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria

• Patients who have had major surgery within 4 weeks, or chemotherapy or radiotherapy within 2 weeks prior to Cycle 1 Day 1.
• All toxicities attributed to prior anti-cancer therapy other than alopecia must have resolved to grade 1 or baseline
• Patients may not be receiving any other investigational agents.
• Patients with known brain metastases due to poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAS-102, irinotecan or other agents used in study.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Prior treatment with irinotecan or TAS-102
• History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ.
• Inability to comply with study and follow-up procedures as judged by the Investigator
• Patients who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taiho Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Farshid Dayyani

Associate Clinical Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Farshid Dayyani, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chao Family Comprehensive Cancer Center

Locations

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, United States

UC Davis Comprehensive Cancer Center

Sacramento, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2019-5179

Identifier Type: OTHER

Identifier Source: secondary_id

UCI 18-125 [HS# 2019-5179]

Identifier Type: -

Identifier Source: org_study_id