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Cisplatin Combined with Oral TS-1 in Patients with Advanced Solid Tumors with Different Degrees of Liver Dysfunction

StatusUnknown
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Active, Not Recruiting
  2. Primary completion date changed from estimate of Dec 20, 2022 to Sep 1, 2024
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v4
  3. Primary completion date: Dec 20, 2021 to Dec 20, 2022v3
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to formally characterize the pharmacokinetics (PK), safety, and tolerability of TS-1 in combination with cisplatin in adult patients with advanced solid tumors who have mild, moderate or severe hepatic impairment relative to patients with normal hepatic function, as categorized by the United States National Cancer Institute organ dysfunction working group \[NCI-ODWG\] criteria for hepatic dysfunction.
Trial Details
NCT Number NCT03519074
Lead Sponsor National University Hospital, Singapore
Conditions
(from sponsor)		 Cancer, Liver Dysfunction
Related terms Liver Diseases, Neoplasms
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov