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An Open Label, Phase 1, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Clinical Activity of Gemcitabine Hydrochloride Oral Formulation(D07001-F4) in Patients With Advanced Solid Malignancies and Malignant Lymphomas

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Trial Profile

An Open Label, Phase 1, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Clinical Activity of Gemcitabine Hydrochloride Oral Formulation(D07001-F4) in Patients With Advanced Solid Malignancies and Malignant Lymphomas

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 03 Jul 2023

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At a glance

  • Drugs Gemcitabine (Primary) ; Gemcitabine (Primary)
  • Indications Lymphoma; Solid tumours
  • Focus Adverse reactions
  • Sponsors INNOPHARMAX

    • Most Recent Events

    • 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
    • 02 Dec 2016 Results presented at the 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics
    • 30 Aug 2016 Status changed from recruiting to completed.

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