Value through Innovation27 July 2016

Clinical Study Results

  • BI 2536 - Neoplasms
    Clinical Study Number 1216.1
    Study Indication Neoplasms
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase I
    Study Title

    An open phase I single dose escalation study of BI 2536 BS administered intravenously in patients with advanced solid tumours with repeated administration in patients with clinical benefit

    Study Document Trial synopsis 1216.1_CO english
  • BI 2536 - Neoplasms
    Clinical Study Number 1216.2
    Study Indication Neoplasms
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase I
    Study Title

    An open phase I repeated dose escalation study of BI 2536 BS administered intravenously in patients with advanced solid tumours with repeated administration in patients with clinical benefit

    Study Document Trial synopsis 1216.2_CO english
  • BI 2536 - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1216.5
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I open-label dose escalation study of intravenous BI 2536 together with pemetrexed in previously treated patients with non-small-cell lung cancer

    Study Document Trial synopsis 1216.5_CO english
  • BI 2536 - Pancreatic Neoplasms
    Clinical Study Number 1216.8
    Study Indication Pancreatic Neoplasms
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I open-label dose-finding study of intravenous BI 2536 administered inrepeated 4-week cycles as repeated doses on Day 1 and Day 15 in combinationwith gemcitabine administered on Day 1, Day 8 and Day 15 in patients withlocally advanced or metastatic pancreatic cancer

    Study Document Trial synopsis 1216.8_CO english
  • BI 2536 - Lymphoma, Non-Hodgkin
    Clinical Study Number 1216.3
    Study Indication Lymphoma, Non-Hodgkin
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase I
    Study Title

    An open Phase I single dose escalation study of BI 2536 administered intravenously in patients with refractory or relapsed non-Hodgkin’s lymphoma

    Study Document Trial synopsis 1216.3_CO english
  • BI 2536 - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1216.9
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase II
    Study Title

    An open, randomised clinical Phase II trial to investigate the efficacy, safety and pharmacokinetics of a single dose of 200 mg of i.v. BI 2536 in comparison to 50 mg of i.v. BI 2536 administered on days 1, 2 and 3 in patients with advanced or metastatic non small cell lung cancer

    Study Document Trial synopsis 1216.9_CO english
  • BI 2536 - Pancreatic Neoplasms
    Clinical Study Number 1216.10
    Study Indication Pancreatic Neoplasms
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase II
    Study Title

    An open, randomised, clinical phase II trial in patients with unresectable advanced pancreatic cancer investigating the efficacy, safety, and pharmacokinetics of BI 2536 administered in repeated 3-week cycles as a single IV dose of 200 mg on Day 1 or as 60 mg doses on Days 1, 2, and 3

    Study Document Trial synopsis 1216.10 english
  • BI 2536 - Carcinoma, Small Cell
    Clinical Study Number 1216.11
    Study Indication Carcinoma, Small Cell
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase II
    Study Title

    An open-label Phase II trial to investigate the efficacy, safety, and pharmacokinetics of a single dose of 200 mg i.v. BI 2536 administered every 21 days in patients with sensitive relapse small cell lung cancer

    Study Document Trial synopsis 1216.11_CO english
  • BI 2536 - Neoplasms
    Clinical Study Number 1216.18
    Study Indication Neoplasms
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase II
    Study Title

    Multicenter parallel phase II trial of BI 2536 administered as a 1 hour i.v. infusion every 3 weeks in defined cohorts of patients with various solid tumours. A new drug screening program of the EORTC network of core institutions (NOCI)

    Study Document Trial synopsis 1216.18_CO english
  • BI 2536 - Prostatic Neoplasms
    Clinical Study Number 1216.19
    Study Indication Prostatic Neoplasms
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase II
    Study Title

    A single arm phase II study to investigate the efficacy, safety and pharmacokinetics of a single dose of 200 mg of i.v. BI 2536, administered once every 3 weeks in patients with advanced metastatic hormone-refractory prostate cancer

    Study Document Trial synopsis 1216.19_CO english
  • BI 2536 - Leukemia, Myeloid, Acute
    Clinical Study Number 1216.20
    Study Indication Leukemia, Myeloid, Acute
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase I/IIa
    Study Title

    An open, randomised clinical Phase I/IIa trial to investigate the maximum tolerated dose, efficacy, safety and pharmacokinetics of repeated three-week courses of a single dose i.v. BI 2536 on Day 1 in comparison to single doses i.v. BI 2536 on Days 1, 2 and 3 in patients over 60 years of age with refractory or relapsed acute myeloid leukaemia

    Study Document Trial synopsis 1216.20_CO english

Clinical Trial Registry and structured study results. Find here protocol information for all clinical study types.

European Trial Register of EU studies.