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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04074343
Recruitment Status : Active, not recruiting
First Posted : August 30, 2019
Last Update Posted : April 6, 2022
Taiho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Farshid Dayyani, University of California, Irvine

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.

Condition or disease Intervention/treatment Phase
Gastric Adenocarcinoma GastroEsophageal Cancer Drug: TAS-102 Drug: Irinotecan Phase 1

Detailed Description:
Treatment on study will be administered in 14 day cycles.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib Multicenter Study of TAS-102 in Combination With Irinotecan in Patients With Advanced Recurrent or Unresectable Gastric and Gastroesophageal Adenocarcinoma After at Least One Line of Treatment With a Fluoropyrimidine and Platinum Containing Regimen
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Drug: TAS-102
Given PO
Other Names:
  • trifluoridine and tipiracil

Drug: Irinotecan
Given IV
Other Names:
  • CPT-11

Primary Outcome Measures :
  1. Percentage of Participants with Progression-free Survival at 6 Months [ Time Frame: 6 Months ]
    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.

Secondary Outcome Measures :
  1. Percentage of Grade 3-5 Adverse Events [ Time Frame: 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.

  2. Overall Response Rate as Assessed by RECIST v1.1 Criteria of Patients Who Received TAS-102 and Irinotecan [ Time Frame: 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 overall response rate to the combination of TAS-102 and Irinotecan. Overall 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

  3. Overall Survival of Patients Who Received TAS-102 and Irinotecan [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04074343

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United States, California
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, United States, 92868
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Irvine
Taiho Pharmaceutical Co., Ltd.
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Principal Investigator: Farshid Dayyani, MD, PhD Chao Family Comprehensive Cancer Center
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Responsible Party: Farshid Dayyani, Associate Clinical Professor of Medicine, University of California, Irvine Identifier: NCT04074343    
Other Study ID Numbers: UCI 18-125 [HS# 2019-5179]
2019-5179 ( Other Identifier: University of California, Irvine )
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Farshid Dayyani, University of California, Irvine:
Gastric Adenocarcinoma
Gastroesophageal Adenocarcinoma
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents