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Trial record 1 of 1 for:    TAS-102 302
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Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer

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.
ClinicalTrials.gov Identifier: NCT02500043
Recruitment Status : Active, not recruiting
First Posted : July 16, 2015
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this trial is to compare the effects of TAS-102 and best supportive care (BSC) with Placebo (an inactive drug) and best supportive care on metastatic gastric cancer.

Condition or disease Intervention/treatment Phase
Refractory Metastatic Gastric Cancer Drug: TAS-102 Drug: Placebo Phase 3

Detailed Description:
This is a multinational, double-blind, two-arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of TAS-102 plus BSC versus placebo plus BSC in patients with metastatic gastric cancer who have previously received at least 2 prior regimens for advanced disease. Eligible patients will be centrally randomized (2:1) to TAS-102 + BSC (experimental arm) or placebo + BSC (control arm).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 506 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Phase 3 Study Evaluating TAS-102 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Gastric Cancer Refractory to Standard Treatments
Study Start Date : December 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: TAS-102
35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle. Number of cycles: approximately 4 or until discontinuation criteria is met.
Drug: TAS-102
35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle.
Experimental: Placebo
35 mg/m2/dose of placebo orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle. Number of cycles: approximately 4 or until discontinuation criteria is met.
Drug: Placebo
35 mg/m2/dose of placebo orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle.


Outcome Measures

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to 3 years ]
    OS is defined as the time from the date of randomization to the date of death.


Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Up to 3 years ]
    PFS is defined as the time from the date of randomization until radiological disease progression or death due to any cause.

  2. Safety and Tolerability [ Time Frame: Up to 3 years ]
    Safety and Tolerability is defined as AEs graded using NCI criteria for AEs (CTCAE).


Other Outcome Measures:
  1. Overall Response Rate (ORR) [ Time Frame: Up to 3 years ]
    ORR is defined as the proportion of patients with objective evidence of complete response or partial response.

  2. Disease Control Rate (DCR) [ Time Frame: Up to 3 years ]
    DCR is defined as the proportion of patients with objective evidence of complete response, partial response or SD.

  3. Time to Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status to Score of 2 or Higher [ Time Frame: Up to 3 years ]
    The time to deterioration of ECOG performance status is defined as the time from randomization to the first date on which an ECOG performance status score of 2 or higher is observed.

  4. Quality of Life [ Time Frame: Up to 3 years ]
    Quality of life is defined as an assessment for health-related quality of life of cancer patients.


Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Has histologically confirmed non-resectable, metastatic gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction.
  2. Has previously received at least 2 prior regimens for advanced disease and were refractory to or unable to tolerate their last prior therapy.
  3. Has measureable or nonmeasurable disease as defined by RECIST 1.1 criteria.
  4. Is able to take medications orally (ie, no feeding tube).
  5. Has an ECOG performance status of 0 or 1.
  6. Has adequate organ function as defined by protocol defined labs.
  7. Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.

Exclusion Criteria:

  1. Has certain serious illnesses or medical conditions
  2. Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent within the specified time frames prior to study drug administration.
  3. Has previously received TAS-102.
  4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies.
  5. Is a pregnant or lactating female.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT02500043


  Show 139 Study Locations
Sponsors and Collaborators
Taiho Oncology, Inc.
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02500043     History of Changes
Other Study ID Numbers: TO-TAS-102-302
2015-002683-16 ( EudraCT Number )
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018

Keywords provided by Taiho Oncology, Inc.:
Gastric Cancer
Metastatic Gastric Cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Trifluridine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents