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A Single-arm, Open Label, Multi-center Phase I/II Trial to Assess the Safety and Efficacy of BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML Unfit for an Intensive Induction Therapy.

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Trial Profile

A Single-arm, Open Label, Multi-center Phase I/II Trial to Assess the Safety and Efficacy of BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML Unfit for an Intensive Induction Therapy.

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 17 Jan 2023

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At a glance

  • Drugs Nintedanib (Primary) ; Cytarabine
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions; Therapeutic Use

    • Most Recent Events

    • 01 Jan 2023 Results (n=31) assessing safety and efficacy of nintedanib added to low-dose cytarabine (LDAC) in a phase 1/2 study in patients 60 years or older with newly diagnosed or relapsed/refractory (r/r) AML ineligible for intensive chemotherapy published in the Annals of Hematology
    • 19 Aug 2021 This trial has been completed in Germany, according to European Clinical Trials Database.
    • 03 Jun 2014 Interim results (n=13) presented at the 50th Annual Meeting of the American Society of Clinical Oncology.

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