This is clinical trial for a registration to investigate superiority of overall survival by TAS-102 plus best supportive care compared to placebo (an inactive drug) plus best supportive care in patients with metastatic gastric cancer who had refractory to standard therapies

Phase 1

• Conditions: Refractory metastatic gastric cancer; MedDRA version: 20.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-002683-16-IT
• Lead Sponsor: TAIHO ONCOLOGY INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-12-19
• Study Start: 2021-02-16
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 507

Inclusion Criteria

A patient must meet all of the following inclusion criteria to be eligible for enrollment in this
study:
1. Has provided written informed consent.
2. Has histologically confirmed non-resectable, metastatic gastric adenocarcinoma including
adenocarcinoma of the gastroesophageal (GE) junction as defined by the American Joint
Committee on Cancer (AJCC) staging classification (7th ed., 2010). Documentation of
histology of the tumor (primary or metastasis) will be required prior to enrollment.
Gastroesophageal junction involvement must be documented by endoscopic, radiologic,
surgical or pathology report.
3. Has previously received at least 2 prior regimens (at least 1 cycle per regimen) for
advanced disease and were refractory to or unable to tolerate their last prior therapy:
a. Prior regimen(s) must have included a fluoropyrimidine, platinum, and either a taxane and/
or irinotecan-containing regimen; patients whose tumors are HER2-neu-positive
(HER2+) must have received prior anti-HER2+ therapy if available.
b. Patients have progressed based on imaging during or within 3 months of the last
administration of their last prior regimen.
c. Patients who have withdrawn from their last prior regimen due to unacceptable
toxicity warranting discontinuation of treatment and precluding retreatment with the
same agent prior to progression of disease will also be eligible to enter the study.
d. Patients who have received postoperative adjuvant chemotherapy or chemo-radiotherapy,
and had recurrence during or within 6 months of completion of the adjuvant
chemotherapy are allowed to count the adjuvant therapy as one prior regimen for
advanced disease. Patients who have received pre- and post-operative adjuvant
chemotherapy, and had recurrence during or within 6 months of completion of the
adjuvant chemotherapy are allowed to count the adjuvant therapy as one prior
regimen only if the same regimen was administered both pre- and post-operatively.
4. Has measureable or nonmeasurable disease as defined by RECIST 1.1 criteria.
5. Is able to take medications orally (ie, study drug must not be administered via a feeding
tube).
6. Is =18 years of age (=20 years for patients in Japan).
7. Has an ECOG performance status of 0 or 1 (see Appendix A) at time of randomization.
8. Has adequate organ function as defined by the following criteria:
a. Absolute neutrophil count (ANC) of =1,500/mm3 (ie, =1.5 × 109/L by International
Units [IU]).
b. Platelet count =100,000/mm3 (IU: =100 × 109/L).
c. Hemoglobin value of =9.0 g/dL prior to randomization based on measurements
obtained 2 weeks or more after last transfusion received.
d. Aspartate aminotransferase (AST; SGOT) and alanine aminotransferase (ALT;
SGPT) =3.0 × upper limit of normal (ULN); if liver function abnormalities are due to
underlying liver metastasis, AST (SGOT) and ALT (SGPT) =5 × ULN.
e. Total serum bilirubin of =1.5 × ULN (except for Grade 1 hyperbilirubinemia due
solely to a medical diagnosis of Gilbert’s syndrome).
f. Serum creatinine =1.5 mg/dL.
9. Is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and
other study procedures.
10.Women of childbearing potential must have a negative pregnancy test (urine or serum) within 7 days prior to starting the study drug. Both males and females must agree to use effective birth control during the study (prior to the first dose and for 6 months after the last dose) if conception is possible during this interval. Female patients

Exclusion Criteria

Exclude a patient from this study if any of the following conditions are
observed:
1. Has a serious illness or medical condition(s) including, but not limited
to the following:
a. Other concurrently active malignancies excluding malignancies that
are disease free for more than 5 years or carcinoma-in-situ deemed
cured by adequate treatment.
b. Known brain metastasis or leptomeningeal metastasis.
c. Active infection (ie, body temperature =38°C due to infection)
including active or unresolved pneumonia/pneumonitis.
d. Intestinal obstruction, pulmonary fibrosis, renal failure, liver failure,
or cerebrovascular disorder.
e. Uncontrolled diabetes.
f. Myocardial infarction within 12 months prior to randomization,
severe/unstable angina, symptomatic congestive heart failure New York
Heart Association (NYHA) class III or IV
g. Gastrointestinal hemorrhage (Grade =3) within 2 weeks prior to
randomization.
h. Known human immunodeficiency virus (HIV) or acquired
immunodeficiency syndrome (AIDS)-related illness, or chronic or acute
hepatitis B or hepatitis C.
i. Patients with autoimmune disorders or history of organ
transplantation who require immunosuppressive therapy.
j. Psychiatric disease that may increase the risk associated with study
participation or study drug administration, or may interfere with the
interpretation of study results.
2. Has had treatment with any of the following within the specified time
frame prior to randomization:
a. Major surgery within prior 4 weeks (the surgical incision should be
fully healed prior to study drug administration).
b. Any anticancer therapy within prior 3 weeks.
c. Extended field radiation within prior 4 weeks or limited field radiation
within prior 2 weeks.
d. Any investigational drug/device received within prior 4 weeks.
3. Has previously received TAS-102.
4. 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).
5. Is a pregnant or lactating female.
6. Is inappropriate for entry into this study in the judgment of the
Investigator.

7.Known or assumed hypersensitivity to TAS-102 or any of its ingredients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified