Value through Innovation27 July 2016

Clinical Study Results

  • Afatinib + Nintedanib - Neoplasms
    Clinical Study Number 1239.1
    Study Indication Neoplasms
    Product Afatinib + Nintedanib
    Generic Name Afatinib + Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    A combination Phase I open-label dose escalation study of concomitant administration of BIBW 2992 with BIBF 1120 in patients with advanced solid tumors

    Study Document Trial synopsis 1239.1_DR english
  • Afatinib + Nintedanib - Neoplasms
    Clinical Study Number 1239.14
    Study Indication Neoplasms
    Product Afatinib + Nintedanib
    Generic Name Afatinib + Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    Phase I Dose escalation study of concomitant BIBF 1120 and BIBW 2992 in patients with advanced solid tumours.

    Study Document Trial synopsis 1239.14_PE english Trial synopsis 1239.14 english
  • 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 - 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 811283 - Neoplasms
    Clinical Study Number 1247.1
    Study Indication Neoplasms
    Product BI 811283
    Generic Name BI 811283
    Lab Code
    Clinical Phase I
    Study Title

    An open phase I single dose escalation study of two dosing schedules of BI 811283 administered intravenously over 24 h continuous infusion in patients with advanced solid tumours with repeated administration in patients with clinical benefit

    Study Document Trial synopsis 1247.1 english
  • BI 831266 - Neoplasms
    Clinical Study Number 1257.1
    Study Indication Neoplasms
    Product BI 831266
    Generic Name BI 831266
    Lab Code
    Clinical Phase I
    Study Title

    An open-label phase I single dose escalation trial of two dosing schedules of BI 831266 administered intravenously over 24 h continuously in patients with advanced solid tumours

    Study Document Trial synopsis 1257.1 english
  • GIOTRIF ® (afatinib) - Neoplasms
    Clinical Study Number 1200.26
    Study Indication Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    An open label Phase II trial of BIBW 2992 (Afatinib) in genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EFGR activating mutations.

    Study Document Trial statement 1200.26_CO english Trial synopsis 1200.26_CO english
  • GIOTRIF ® (afatinib) - Neoplasms
    Clinical Study Number 1200.24
    Study Indication Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    Phase II open label trial to assess the efficacy and the impact on QTcF of continuous oral BIBW 2992 at a daily dose of 50 mg in patients with relapsed or refractory solid tumours including patients with brain metastases and those with glioblastoma not amenable to other therapy

    Study Document Trial synopsis 1200.24 english
  • GIOTRIF ® (afatinib) - Neoplasms
    Clinical Study Number 1200.37
    Study Indication Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase Ib
    Study Title

    A phase Ib open label study to assess the safety, tolerability and pharmacokinetics of continuous dosing with BIBW 2992 combined with two different regimens of backbone chemotherapy: cisplatin combined with 5-fluorouracil and cisplatin combined with paclitaxel in patients with advanced solid tumours

    Study Document Trial synopsis 1200.37 english
  • GIOTRIF ® (afatinib) - Neoplasms
    Clinical Study Number 1200.69
    Study Indication Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    Phase I open label trial to assess safety of BIBW 2992 in combination with vinorelbine (i.v. and oral) in patients with solid tumours historically known to overexpress HER2 and /or EGFR and not amenable to other treatment and with an indication for vinorelbine therapy

    Study Document Trial synopsis 1200.69 english
  • GIOTRIF ® (afatinib) - Neoplasms
    Clinical Study Number 1200.92
    Study Indication Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I open-label dose escalation study to assess the safety, tolerability and   pharmacokinetics of continuous and pulsed daily dosing of BIBW 2992 combined with pemetrexed given every 21 days in patients with advanced solid tumours

    Study Document Trial synopsis 1200.92_DS_CO english
  • GIOTRIF ® (afatinib) - Neoplasms
    Clinical Study Number 1200.84
    Study Indication Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    An open-label Phase I study of once daily oral treatment with BIBW 2992 in combination with weekly vinorelbine intravenous injection in Japanese patients with advanced solid tumours

    Study Document Trial synopsis 1200.84_CO english
  • GIOTRIF ® (afatinib) - Neoplasms
    Clinical Study Number 1200.1
    Study Indication Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I open label dose escalation study of once-daily oral treatment with BIBW 2992 for 14 days in patients with advanced solid tumors

    Study Document Trial synopsis 1200.1 english
  • GIOTRIF ® (afatinib) - Neoplasms
    Clinical Study Number 1200.17
    Study Indication Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I open-label extension study of 1200.1 and 1200.2 of once-daily oral treatment with BIBW 2992 in patients with advanced solid tumors

    Study Document Trial synopsis 1200.17_CO english
  • GIOTRIF ® (afatinib) - Neoplasms
    Clinical Study Number 1200.2
    Study Indication Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I open-label dose escalation study of once-daily oral treatment with BIBW 2992 for 21 days in patients with advanced solid tumors

    Study Document Trial synopsis 1200.2 english
  • GIOTRIF ® (afatinib) - Neoplasms
    Clinical Study Number 1200.3
    Study Indication Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I open-label dose escalation study of continuous once-daily oral treatment with BIBW 2992 in patients with advanced solid tumours

    Study Document Trial synopsis 1200.3_CO english
  • GIOTRIF ® (afatinib) - Neoplasms
    Clinical Study Number 1200.4
    Study Indication Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I open-label dose escalation study of continuous once-daily oral treatment with BIBW 2992 in patients with advanced solid tumors

    Study Document Trial synopsis 1200.4_CO english
  • GIOTRIF ® (afatinib) - Neoplasms
    Clinical Study Number 1200.6
    Study Indication Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I dose escalation trial of BIBW 2992 administration for 20, 13 or 6 days in combination with docetaxel every 21 days

    Study Document Trial synopsis 1200.6_CO english
  • GIOTRIF ® (afatinib) - Neoplasms
    Clinical Study Number 1200.20
    Study Indication Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I open-label dose escalation study of single oral daily doses of BIBW 2992 for three days after administration of docetaxel, in patients with advanced solid tumors

    Study Document Trial synopsis 1200.20_CO english
  • GIOTRIF ® (afatinib) - Neoplasms
    Clinical Study Number 1200.122
    Study Indication Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase Ib
    Study Title

    A Phase Ib dose escalation study of afatinib in combination with cetuximab inpatients with advanced solid tumours

    Study Document Trial synopsis 1200.122 english
  • GIOTRIF ® (afatinib) - Neoplasms
    Clinical Study Number 1200.12
    Study Indication Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase Ib
    Study Title

    A phase I open label trial of continuous dosing with BIBW 2992 combined with paclitaxel and BIBW 2992 combined with paclitaxel and bevacizumab, BIBW 2992 combined with carboplatin and BIBW 2992 combined with paclitaxel and carboplatin in patients with advanced solid tumours

    Study Document Trial synopsis 1200.12 english
  • GIOTRIF ® (afatinib) - Neoplasms
    Clinical Study Number 1200.93
    Study Indication Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    A phase I dose escalation trial of once daily oral treatment using afatinib (BIBW2992) plus gemcitabine or docetaxel in patients with relapsed or refractory solid tumors

    Study Document Trial synopsis 1200.93_DR english
  • VARGATEF ® - Neoplasms
    Clinical Study Number 1199.16
    Study Indication Neoplasms
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I/II
    Study Title

    A phase I/II open label extension study of BIBF 1120 administered orally once or twice daily to establish safety, pharmacokinetics and efficacy in patients with advanced solid tumours and clinical benefit from previous therapy with BIBF 1120

    Study Document Trial synopsis 1199.16_DS_DR english
  • VARGATEF ® - Neoplasms
    Clinical Study Number 1199.1
    Study Indication Neoplasms
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase Ib
    Study Title

    Phase I dose escalation study of BIBF 1120 in patients with various solid tumours

    Study Document Trial synopsis 1199.1_CO english
  • VARGATEF ® - Neoplasms
    Clinical Study Number 1199.3
    Study Indication Neoplasms
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase Ib
    Study Title

    Phase I study of escalating continous doses of BIBF 1120 in patients with various cancers

    Study Document Trial synopsis 1199.3 english
  • VARGATEF ® - Neoplasms
    Clinical Study Number 1199.19
    Study Indication Neoplasms
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase Ib
    Study Title

    A Phase I open-label dose-escalation study of continuous twice-daily oral treatment with BIBF 1120 in Japanese patients with advanced solid tumours

    Study Document Trial synopsis 1199.19_CO english
  • Volasertib - Neoplasms
    Clinical Study Number 1230.15
    Study Indication Neoplasms
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study Title

    An open-label phase I study of once every three weeks intravenous treatment with BI 6727 in Japanese patients with advanced solid tumours

    Study Document Trial synopsis 1230.15 english
  • Volasertib - Neoplasms
    Clinical Study Number 1230.16
    Study Indication Neoplasms
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study Title

    A Phase I single dose escalation study of two dosing schedules of BI 6727 administered intravenously in Asian patients with various solid cancers with repeated administration in patients with clinical benefit

    Study Document Trial synopsis 1230.16 english
  • Volasertib - Neoplasms
    Clinical Study Number 1230.20
    Study Indication Neoplasms
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study Title

    An open label phase I dose escalation trial of intravenous BI 6727 in combination with oral BIBW 2992 in patients with advanced solid tumours with repeated administration in patients with clinical benefit

    Study Document Trial synopsis 1230.20 english
  • Volasertib - Neoplasms
    Clinical Study Number 1230.23
    Study Indication Neoplasms
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study Title

    Investigation of the metabolism, excretion and pharmacokinetics of an open-label single dose 300 mg (14C)volasertib administered intravenously in patients with various solid tumours with a possible extension phase with non-labelled drug

    Study Document Trial synopsis 1230.23 english
  • Volasertib - Neoplasms
    Clinical Study Number 1230.6
    Study Indication Neoplasms
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study Title

    A phase I dose escalation trial of BI 6727 in combination with cisplatin or carboplatin in patients with advanced or metastatic solid tumours

    Study Document Trial synopsis 1230.6 english
  • Volasertib - Neoplasms
    Clinical Study Number 1230.7
    Study Indication Neoplasms
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study Title

    An open label phase I dose escalation trial of intravenous BI 6727 in combination with oral BIBF 1120 in patients with advanced solid tumours with repeated administration in patients with clinical benefit

    Study Document Trial synopsis 1230.7 english
  • Volasertib - Neoplasms
    Clinical Study Number 1230.27
    Study Indication Neoplasms ; Leukemia
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase I
    Study Title

    Open, non-controlled, dose-escalating Phase I trial to evaluate the pharmacokinetics, pharmacodynamics, tolerability, and toxicity of volasertib in paediatric patients from 2 years to less than 18 years of age with acute leukaemia or advanced solid tumour, for whom no effective treatment is known

    Study Document Trial synopsis 1230.27 english Lay summary 1230.27 english
  • BI 860585 - Neoplasms
    Clinical Study Number 1325.1
    Study Indication Neoplasms
    Product BI 860585
    Generic Name BI 860585
    Lab Code BI 860585
    Clinical Phase I
    Study Title

    An open-label, Phase I, dose-finding study of BI 860585 administered orally in a continuous dosing schedule as a single agent and in combination with exemestane or with paclitaxel in patients with various advanced and/or metastatic solid tumours

    Study Document Trial synopsis 1325.1 english
  • BI 847325 - Neoplasms
    Clinical Study Number 1287.1
    Study Indication Neoplasms
    Product BI 847325
    Generic Name BI 847325
    Lab Code
    Clinical Phase Ia/Ib
    Study Title

    An open-label, uncontrolled Phase Ia/Ib study of two dosing schedules of BI 847325 orally administered once a day in patients with advanced solid tumours, with repeated administration in patients with clinical benefit

    Study Document Trial synopsis 1287.1 english

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