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Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of Simmitecan and Simmitecan, 5-fluorouracil and Leucovorin Calcium, in Patients With Advanced Solid Tumors

Trial Profile

Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of Simmitecan and Simmitecan, 5-fluorouracil and Leucovorin Calcium, in Patients With Advanced Solid Tumors

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Simmitecan (Primary) ; Fluorouracil; Folinic acid; Thalidomide
  • Indications Biliary cancer; Carcinoma; Colorectal cancer; Gallbladder cancer; Gastric cancer; Gastrointestinal cancer; Gastrointestinal stromal tumours; Liver cancer; Neuroendocrine carcinoma; Oesophageal cancer; Pancreatic cancer; Solid tumours
  • Focus Pharmacokinetics
  • Sponsors Haihe Biopharma; ShangHai HaiHe Pharmaceutical
  • Most Recent Events

    • 31 May 2020 Results (n=41) assessing safety and efficacy presented at the 56th Annual Meeting of the American Society of Clinical Oncology
    • 18 Jul 2017 Number of arms of the study has increased from 4 to 6,hence number of planned patient number has also changed from 153 to243.
    • 11 Jul 2017 Planned number of patients changed from 158 to 243.
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