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Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer

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ClinicalTrials.gov Identifier: NCT02500043
Recruitment Status : Completed
First Posted : July 16, 2015
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.

Tracking Information
First Submitted Date  ICMJE July 13, 2015
First Posted Date  ICMJE July 16, 2015
Last Update Posted Date October 1, 2018
Study Start Date  ICMJE December 2015
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2015)
Overall Survival [ Time Frame: Up to 3 years ]
OS is defined as the time from the date of randomization to the date of death.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2015)
  • 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.
  • Safety and Tolerability [ Time Frame: Up to 3 years ]
    Safety and Tolerability is defined as AEs graded using NCI criteria for AEs (CTCAE).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 27, 2018)
  • 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.
  • 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.
  • 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.
  • Quality of Life as an assessment for health-related [ Time Frame: Up to 3 years ]
    Quality of life is defined as an assessment for health-related quality of life of cancer patients.
Original Other Pre-specified Outcome Measures
 (submitted: July 14, 2015)
  • 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.
  • 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.
  • 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.
  • 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.
 
Descriptive Information
Brief Title  ICMJE Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Refractory Metastatic Gastric Cancer
Intervention  ICMJE
  • 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.
  • Drug: Placebo
    35 mg/m2/dose of placebo orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: TAS-102
  • 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.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2018)
506
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2015)
500
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belarus,   Belgium,   Canada,   Czechia,   France,   Germany,   Ireland,   Israel,   Italy,   Japan,   Poland,   Portugal,   Romania,   Russian Federation,   Spain,   Turkey,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02500043
Other Study ID Numbers  ICMJE TO-TAS-102-302
2015-002683-16 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Taiho Oncology, Inc.
Study Sponsor  ICMJE Taiho Oncology, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Taiho Oncology, Inc.
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP