Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin in Patients With Advanced Gastric Cancer (SOLAR)

• ClinicalTrials.gov Identifier: NCT02322593
• Recruitment Status: Completed
• First Posted: December 23, 2014
• Results First Posted: December 20, 2021
• Last Update Posted: December 20, 2021
• Sponsor: Taiho Pharmaceutical Co., Ltd.
• Collaborator: Yakult Honsha Co., LTD
• Information provided by (Responsible Party): Taiho Pharmaceutical Co., Ltd.

Tracking Information

• First Submitted Date: December 12, 2014
• First Posted Date: December 23, 2014
• Results First Submitted Date: August 24, 2021
• Results First Posted Date: December 20, 2021
• Last Update Posted Date: December 20, 2021
• Actual Study Start Date: December 2014
• Actual Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 10, 2021)

Overall Survival [ Time Frame: A survival follow-up was required every 12 weeks from the date of randomization to the date of death from any cause, whichever came first, assessed up to 38 months. ]

The primary endpoint was OS, which was defined as the time from the date of randomization to the date of death from any cause. Surviving patients were censored at the cutoff date or last contact date if lost to follow-up, or upon withdrawal of consent.

• Original Primary Outcome Measures (submitted: December 17, 2014): Overall survival [ Time Frame: 4 years ]

Current Secondary Outcome Measures (submitted: November 10, 2021)

• Progression-free Survival [ Time Frame: A radiographic imaging examination using CT or MRI was repeated every 6 weeks. Tumor assessments were performed from the date of randomization to the date of disease progression or death from any cause, whichever came first. ]
  PFS was defined as the time from the date of randomization to the date of disease progression (assessed by each investigator) or death from any cause, whichever came first.
• Time to Treatment Failure [ Time Frame: From the date of randomization to the date of the last administration of the study drug. ]
  TTF was defined as the time from the date of randomization to the date of the last administration of the study drug. Patients on study treatment were censored at the date of the last administration or the cutoff date, whichever came earlier.
• Overall Response Rate [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months. ]
  ORR was defined as the proportion of patients with the best unconfirmed overall response of complete response (CR) or partial response (PR) in patients with measurable lesions
• Disease Control Rate [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months. ]
  DCR was defined as the proportion of patients with CR, PR, or stable disease in patients with measurable lesions.

Original Secondary Outcome Measures (submitted: December 17, 2014)

• Progression-free survival [ Time Frame: 4 years ]
• Time to treatment failure [ Time Frame: 4 years ]
• Overall response rate [ Time Frame: 4 years ]
• Disease control rate [ Time Frame: 4 years ]
• Safety monitoring including adverse events, vital signs, and laboratory assessments. [ Time Frame: 4 years ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin in Patients With Advanced Gastric Cancer
• Official Title: An Open-label Randomized Multi-center Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin as First-line Therapy in Patients With Advanced Gastric Cancer
• Brief Summary: The purpose of this trial is to evaluate the efficacy of TAS-118 plus Oxaliplatin compared with S-1 plus Cisplatin in overall survival in patients with advanced gastric cancer.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Gastric Cancer

Intervention

• Drug: TAS-118 plus Oxaliplatin
• Drug: S-1 plus Cisplatin

Study Arms

• Experimental: TAS-118/Oxaliplatin
  TAS-118 plus Oxaliplatin
  Intervention: Drug: TAS-118 plus Oxaliplatin
• Active Comparator: S-1/Cisplatin
  S-1 plus Cisplatin
  Intervention: Drug: S-1 plus Cisplatin

• Publications *: Kang YK, Chin K, Chung HC, Kadowaki S, Oh SC, Nakayama N, Lee KW, Hara H, Chung IJ, Tsuda M, Park SH, Hosaka H, Hironaka S, Miyata Y, Ryu MH, Baba H, Hyodo I, Bang YJ, Boku N. S-1 plus leucovorin and oxaliplatin versus S-1 plus cisplatin as first-line therapy in patients with advanced gastric cancer (SOLAR): a randomised, open-label, phase 3 trial. Lancet Oncol. 2020 Aug;21(8):1045-1056. doi: 10.1016/S1470-2045(20)30315-6. Epub 2020 Jul 16.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 31, 2020): 711
• Original Estimated Enrollment (submitted: December 17, 2014): 686
• Actual Study Completion Date: May 2020
• Actual Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria:

• Patients who are diagnosed as gastric cancer.
• No prior treatment for gastric cancer.
• Negative or unknown for HER2 testing.
• ECOG performance status of 0 or 1.

Key Exclusion Criteria:

• Unmanageable diarrhea.
• Current peripheral sensory neuropathy or paresthesia.
• Pregnant or lactating female.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan, Korea, Republic of

Administrative Information

• NCT Number: NCT02322593
• Other Study ID Numbers: 10056040
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Taiho Pharmaceutical Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Taiho Pharmaceutical Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Yakult Honsha Co., LTD
• Investigators: Not Provided
• PRS Account: Taiho Pharmaceutical Co., Ltd.
• Verification Date: November 2021