An Open-Label, Exploratory, Limited Dose Escalation Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Gemcitabine Hydrochloride Oral Formulation (D07001-F4) in Subjects With Malignant Tumors

Trial Profile

An Open-Label, Exploratory, Limited Dose Escalation Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Gemcitabine Hydrochloride Oral Formulation (D07001-F4) in Subjects With Malignant Tumors

Completed
Phase of Trial: Phase 0

Latest Information Update: 16 Sep 2016

At a glance

  • Drugs Gemcitabine (Primary)
  • Indications Solid tumours
  • Focus Pharmacokinetics
  • Sponsors INNOPHARMAX
  • Most Recent Events

    • 02 Jun 2015 Based on the absence of drug-related adverse events, it was concluded that single doses used in this study were were safe and well-tolerated and another phase I study has been initiated to determine the maximum tolerated dose , according to an ASCO abstract.
    • 02 Jun 2015 Results presented at the 51st Annual Meeting of the American Society of Clinical Oncology.
    • 19 May 2014 Trial status changed to completed as reported by ClinicalTrials.gov.
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