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Open-Label, Multicenter Study of D07001-Softgel Capsules (Oral Gemcitabine Hydrochloride) in Subjects With Unresectable, Metastatic or Locally Advanced Gastrointestinal (GI) Cancer in Dose-Escalation Phase and in Subjects With Advanced Biliary Tract Cancer (BTC) Following Primary Chemotherapy or Combined Chemoradiotherapy (CCRT) in Dose-Expansion Phase

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Trial Profile

Open-Label, Multicenter Study of D07001-Softgel Capsules (Oral Gemcitabine Hydrochloride) in Subjects With Unresectable, Metastatic or Locally Advanced Gastrointestinal (GI) Cancer in Dose-Escalation Phase and in Subjects With Advanced Biliary Tract Cancer (BTC) Following Primary Chemotherapy or Combined Chemoradiotherapy (CCRT) in Dose-Expansion Phase

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 28 Nov 2023

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At a glance

  • Drugs Gemcitabine (Primary)
  • Indications Cholangiocarcinoma; Gallbladder cancer; Gastrointestinal cancer
  • Focus Adverse reactions
  • Sponsors INNOPHARMAX

    • Most Recent Events

    • 01 Nov 2023 Status changed from discontinued to completed.
    • 06 Jun 2023 Results from two phase 1 studies NCT01800630, NCT03531320 assessing dose-limiting toxicity (DLT), pharmacokinetics (PK), bioavailability (BA) and maximum tolerated dose (MTD) of D07001-F4 and D07001-softgel capsules in subjects with refractory, advanced solid tumors presented at the 59th Annual Meeting of the American Society of Clinical Oncology
    • 25 Aug 2021 Status changed from active, no longer recruiting to discontinued.
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