History of Changes for Study: NCT02500043

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

Latest version (submitted August 19, 2021) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	July 14, 2015	None (earliest Version on record)
2	August 5, 2015	Study Status and Contacts/Locations
3	January 4, 2016	Recruitment Status, Study Status, Contacts/Locations and Oversight
4	January 6, 2016	Contacts/Locations and Study Status
5	June 24, 2016	Study Status and Contacts/Locations
6	July 6, 2016	Study Status and Contacts/Locations
7	January 19, 2017	Contacts/Locations and Study Status
8	May 22, 2017	Contacts/Locations and Study Status
9	June 6, 2017	Contacts/Locations and Study Status
10	June 12, 2017	Contacts/Locations and Study Status
11	July 11, 2017	Study Status and Contacts/Locations
12	July 26, 2017	Contacts/Locations and Study Status
13	October 6, 2017	Contacts/Locations and Study Status
14	January 4, 2018	Recruitment Status, Study Status, Contacts/Locations and Study Design
15	September 27, 2018	Recruitment Status, Study Status and Outcome Measures
	Results Submission Events
July 2, 2021		Returned after QC review: July 28, 2021
16	August 19, 2021	Outcome Measures, Study Status, Arms and Interventions, Oversight, Document Section, Results, Eligibility, Study Design and Study Description

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Study NCT02500043
Submitted Date: July 14, 2015 (v1)

Study Identification


Unique Protocol ID:	TO-TAS-102-302
Brief Title:	Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer
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
Secondary IDs:	2015-002683-16 [EudraCT Number]

Study Status


Record Verification:	July 2015
Overall Status:	Not yet recruiting
Study Start:	December 2015
Primary Completion:	June 2018 [Anticipated]
Study Completion:	December 2018 [Anticipated]

First Submitted:	July 13, 2015
First Submitted that Met QC Criteria:	July 14, 2015
First Posted:	July 16, 2015 [Estimate]

Last Update Submitted that Met QC Criteria:	July 14, 2015
Last Update Posted:	July 16, 2015 [Estimate]

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.

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
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	500 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Has histologically confirmed non-resectable, metastatic gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction. Has previously received at least 2 prior regimens for advanced disease and were refractory to or unable to tolerate their last prior therapy. Has measureable or nonmeasurable disease as defined by RECIST 1.1 criteria. Is able to take medications orally (ie, no feeding tube). Has an ECOG performance status of 0 or 1. Has adequate organ function as defined by protocol defined labs. 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: Has certain serious illnesses or medical conditions 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. Has previously received TAS-102. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies. Is a pregnant or lactating female.

Contacts/Locations


Central Contact Person:	Robert Winkler, MD Telephone: 609-750-5300 Email: rwinkler@taihooncology.com
Study Officials:	David H Ilson, MD, PhD Principal Investigator Memorial Sloan Kettering Cancer Center
	Josep Tabernero, MD, PhD Principal Investigator Vall d'Hebron University Hospital
	Toshihiko Doi, MD, PhD Principal Investigator National Cancer Center Hospital East
Locations:

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