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: Therapeutic area: Diseases [C] - Cancer [C04]; Refractory metastatic gastric cancer; MedDRA version: 20.0 Level: LLT Classification code 10007050 Term: Cancer System Organ Class: 100000004864

• Registration Number: EUCTR2015-002683-16-CZ
• Lead Sponsor: Taiho Oncology, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-07
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 500

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 regimens must have included a fluoropyrimidine, platinum, and either a taxaneand/ 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c. Patients who have withdrawn from their last prior regimen due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to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 and 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 at time of randomisation
8. Has adequate organ function as defined by the following criteria:
a. Absolute neutrophil count (ANC) of =1,500/mm3 (ie, =1.5 × 10(9)/L by International Units [IU]).
b. Platelet count =100,000/mm3 (IU: =100 × 10(9)/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.

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.

Study & Design

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