Value through Innovation27 July 2016

Clinical Study Results

  • GIOTRIF ® (afatinib) - Head and Neck Neoplasms
    Clinical Study Number 1200.43
    Study Indication Head and Neck Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase III
    Study Title

    LUX-Head & Neck 1: A randomised, open-label, phase III study to evaluate the efficacy and safety of oral afatinib (BIBW 2992) versus intravenous methotrexate in patients with recurrent and/or metastatic head and neck squamous cell carcinoma who have progressed after platinum-based therapy

    Study Document Trial synopsis 1200.43 english Lay summary 1200.43 english Lay summary 1200.43 czech Lay summary 1200.43 danish Lay summary 1200.43 dutch Lay summary 1200.43 french Lay summary 1200.43 german Lay summary 1200.43 greek Lay summary 1200.43 italian Lay summary 1200.43 spanish Lay summary 1200.43 swedish
  • 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) - Breast Neoplasms
    Clinical Study Number 1200.5
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    A phase II study of BIBW 2992 added to letrozole in patients with ER+ve   hormone refractory metastatic breast cancer progressing on letrozole

    Study Document Trial synopsis 1200.5_DR english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.10
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    An open-label phase II trial to assess the efficacy and safety of a once daily oral   dose of 50 mg BIBW 2992 in two cohorts of patients with HER2-negative metastatic breast cancer after failure of no more than two chemotherapy regimen

    Study Document Trial synopsis 1200.10_DS_DR english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.11
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    Phase II trial of BIBW 2992 in patients with HER2-positive metastatic breast cancer after failure of trastuzumab therapy

    Study Document Trial synopsis 1200.11_DR english
  • GIOTRIF ® (afatinib) - Healthy
    Clinical Study Number 1200.151
    Study Indication Healthy
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of a single oral dose of 40 mg afatinib given alone compared to concomitant and timed administration of multiple oral doses of ritonavir – an open-label, randomised, three-way crossover trial in healthy male volunteers

    Study Document Trial synopsis 1200.151_DR english
  • GIOTRIF ® (afatinib) - Healthy
    Clinical Study Number 1200.152
    Study Indication Healthy
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of a single oral dose of 40 mg afatinib given alone and after multiple doses of rifampicin – an open-label, two-period, fixed sequence clinical phase I trial in healthy male volunteers

    Study Document Trial synopsis 1200.152_DR english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.22
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    LUX Lung 2: A Phase II single arm trial of BIBW 2992 in non-small cell lung cancer patients with EGFR activating mutations

    Study Document Trial synopsis 1200.22_PE_DS_CO english Trial synopsis 1200.22_DS_CO english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.23
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase IIb/III
    Study Title

    Phase IIb/III randomised, double-blind trial of BIBW 2992 plus best supportive care (BSC) versus placebo plus BSC in non-small cell lung cancer patients failing erlotinib or gefitinib (LUX-Lung 1)

    Study Document Trial snopsis 1200.23_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) - Head and Neck Neoplasms
    Clinical Study Number 1200.28
    Study Indication Head and Neck Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    A randomized, open-label Phase II study of BIBW 2992 versus cetuximab (Erbitux®) in patients with metastatic or recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) after failure of platinum-containing therapy with a cross-over period for progressing patients

    Study Document Trial synopsis 1200.28_CO english
  • GIOTRIF ® (afatinib) - Glioma
    Clinical Study Number 1200.36
    Study Indication Glioma
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I/II
    Study Title

    BIBW 2992 with or without daily temozolomide in the treatment of patients with recurrent malignant glioma

    Study Document Trial synopsis 1200.36_prim_anal_DS_CO english Trial synopsis 1200.36_final 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) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.32
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase III
    Study Title

    LUX-Lung 3; A randomised, open-label, phase III study of BIBW 2992 versus chemotherapy as first-line treatment for patients with stage IIIB or IV adenocarcinoma of the lung harbouring an EGFR-activating mutation

    Study Document Trial synopsis 1200.32 english Lay summary 1200.32 english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.33
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I/II
    Study Title

    LUX-Lung 4: A Phase I/II open label trial of continuous once daily oral treatment with BIBW 2992 – Phase I trial in advanced non small cell lung cancer patients & Phase II trial in non small cell lung cancer patients failing erlotinib or gefitinib – Full Analysis for Phase I. LUX-Lung 4: A Phase I/II open label trial of continuous once daily oraltreatment with BIBW 2992 – Phase I trial in advanced non small cell lung cancerpatients & Phase II trial in non small cell lung cancer patients failing erlotinib orgefitinib – Full Analysis for Phase II

    Study Document Trial synopsis 1200.33_Ph_1_DS_CO english Trial synopsis 1200.33_Ph_2_CO english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.41
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    A Phase II single-arm trial of BIBW 2992 in demographically and genotypically selected non-small cell lung cancer patients

    Study Document Trial synopsis 1200.41_DR english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.44
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    A neoadjuvant, randomized, open-label Phase II trial of BIBW 2992 versus  trastuzumab versus lapatinib in patients with locally advanced HER2 –positive  breast cancer

    Study Document Trial synopsis 1200.44_DS_CO english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.68
    Study Indication Breast 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 Herceptin® in patients with HER2-positive advanced breast cancer

    Study Document Trial synopsis 1200.68_CO 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) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.72
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    A Phase II trial of BIBW 2992 as a third-line treatment for patients with stage IIIB/IV adenocarcinoma of the lung harbouring wild-type EGFR

    Study Document Trial synopsis 1200.72_DS_CO english
  • GIOTRIF ® (afatinib) - Colorectal Neoplasms
    Clinical Study Number 1200.74
    Study Indication Colorectal Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    An open label, partially randomised Phase II trial to investigate the efficacy and   safety of BIBW 2992 in patients with metastatic colorectal cancer who never   received prior anti-EGFR treatment

    Study Document Triall synopsis 1200.74_DR english
  • GIOTRIF ® (afatinib) - Liver Diseases
    Clinical Study Number 1200.86
    Study Indication Liver Diseases
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, safety and tolerability of different oral doses of afatinib, in  subjects with mild to moderate hepatic impairment compared to healthy   subjects—a phase I, single-dose, open-label, dose-escalation study in a matched   group design

    Study Document Trial synopsis 1200.86 english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.40
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    A phase II single-arm trial of BIBW 2992 in EGFR FISH positive non-small cell lung cancer patients

    Study Document Trial synopsis 1200.40_DR english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.34
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase III
    Study Title

    LUX-Lung 6: A randomised, open-label, phase III study of BIBW 2992 versus chemotherapy as first-line treatment for patients with stage IIIB or IV adenocarcinoma of the lung harbouring an EGFR-activating mutation

    Study Document Trial synopsis 1200.34_PE 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) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.71
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase Ib
    Study Title

    A Phase Ib open-label clinical trial of continuous once daily oral treatment using BIBW 2992 plus cetuximab (Erbitux®) in patients with non-small cell lung cancer with progression following prior erlotinib (Tarceva®) or gefitinib (Iressa®)

    Study Document Trial synopsis 1200.71_PE_DR english Trial synopsis 1200.71_DR 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) - Breast Neoplasms
    Clinical Study Number 1200.75
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase III
    Study Title

    LUX-Breast 1; An open label, randomised phase III trial of BIBW 2992 and vinorelbine versus trastuzumab and vinorelbine in patients with metastatic HER2-overexpressing breast cancer failing one prior trastuzumab treatment

    Study Document Trial synopsis 1200.75_CO english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.42
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase III
    Study Title

    Phase III randomized trial of BIBW 2992 plus weekly paclitaxel versus Investigator's choice of chemotherapy following BIBW 2992 monotherapy in non-small cell lung cancer patients failing previous erlotinib or gefitinib treatment (LUX lung 5)

    Study Document Trial synopsis 1200.42_OS 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) - Healthy
    Clinical Study Number 1200.25
    Study Indication Healthy
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    Metabolism and pharmacokinetics of [14C]-BIBW 2992 MA2 after administration of single doses of 15 mg [14C]-BIBW 2992 MA2 oral solution in healthy male volunteers

    Study Document Trial synopsis 1200.25_CO english
  • GIOTRIF ® (afatinib) - Healthy
    Clinical Study Number 1200.35
    Study Indication Healthy
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of a single dose of 20 mg BIBW 2992 administered as tablet (final formulation) compared to BIBW 2992 drinking solution andBIBW 2992 tablet (trial formulation II) following oral administration to healthy male volunteers (an open-label, randomised, single-dose, three-way crossover phase I study)

    Study Document Trial synopsis 1200.35 english
  • GIOTRIF ® (afatinib) - Healthy
    Clinical Study Number 1200.79
    Study Indication Healthy
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of a single oral dose of BIBW 2992 (20 mg) after coadministration with multiple oral doses of ritonavir (200 mg bid for 3 days) compared to the bioavailability of a single oral dose of BIBW 2992 (20 mg) alone in healthy male volunteers (an open-label, randomised, two-way crossover, clinical phase I study)

    Study Document Trial synopsis 1200.79 english
  • GIOTRIF ® (afatinib) - Healthy
    Clinical Study Number 1200.80
    Study Indication Healthy
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, safety and tolerability of BIBW 2992 administered orally as 20 mg, 30 mg, 40 mg, and 50 mg tablets (final formulation) to healthy male volunteers in an open-label, single rising dose, Phase I trial

    Study Document Trial synopsis 1200.80 english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.67
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    LUX-Breast 3; Randomised phase II study of afatinib alone or in combination with vinorelbine versus investigator’s choice of treatment in patients with HER2-positive breast cancer with progressive brain metastases after trastuzumab and/or lapatinib based therapy

    Study Document Trial synopsis 1200.67_DR english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.70
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase Ib
    Study Title

    A Phase Ib open-label clinical trial of continuous once daily oral treatment using BIBW 2992 plus sirolimus in patients with non-small cell lung cancer harbouring an EGFR mutation and/or disease progression following prior erlotinib or gefitinib

    Study Document Trial synopsis 1200.70_DR english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.89
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    An open label, phase II trial of afatinib with or without vinorelbine for the treatment of HER2-overexpressing inflammatory breast cancer

    Study Document Trial snyopsis 1200.89_DR 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) - Renal Insufficiency
    Clinical Study Number 1200.216
    Study Indication Renal Insufficiency
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, safety and tolerability after single dose administration of afatinib in moderate and severe renal impairment in comparison to subjects with normal renal function (a mono-centric, open-label study in matched-group design)

    Study Document Trial synopsis 1200.216 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) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.125
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase III
    Study Title

    LUX-Lung 8: A randomized, open-label phase III trial of afatinib versus erlotinib in patients with advanced squamous cell carcinoma of the lung as second-line therapy following first-line platinum-based chemotherapy

    Study Document Trial synopsis 1200.125_OS english Lay summary 1200.125_OS 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
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.167
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase IIIb
    Study Title

    A Phase IIIb, non-randomized, open-label, two-cohort study in patients with EGFR mutations-positive advanced adenocarcinoma of the lung, assessing the utility of the Afatinib Diarrhea Assessment and Management guidelines (ADAM)

    Study Document Trial synopsis 1200.167_DR english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.121
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase Ib
    Study Title

    A Phase 1b study of intermittent administration of high doses of the irreversible EGFR inhibitor afatinib as a means of achieving plasma levels active against non-small cell lung cancer with known T790M mutations

    Study Document Trial synopsis 1200.121_DR english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.123
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase IIb
    Study Title

    LUX-Lung 7: A randomised, open-label Phase IIb Trial of afatinib versus gefitinib as first-line treatment of patients with EGFR mutation positive advanced adenocarcinoma of the lung

    Study Document Trial synopsis 1200.123_primary_analysis english Lay summary 1200.123_primary_analysis english Trial synopsis 1200.123_overall_survival english Lay summary 1200.123_overall_survival english
  • GIOTRIF ® (afatinib) - Head and Neck Neoplasms
    Clinical Study Number 1200.131
    Study Indication Head and Neck Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase III
    Study Title

    LUX-Head & Neck 2: A randomised, double-blind, placebo-controlled, phase III study to evaluatethe efficacy and safety of afatinib (BIBW 2992) as adjuvant therapy after chemo-radiotherapy in primary unresected patients with stage III, IVa, or IV bloco-regionally advanced head and neck squamous cell carcinoma

    Study Document Trial statement 1200.131_DR english Trial synopsis 1200.131 english
  • GIOTRIF ® (afatinib) - Head and Neck Neoplasms
    Clinical Study Number 1200.162
    Study Indication Head and Neck Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of afatinib (BIBW 2992) as adjuvant therapy after chemoradiotherapy in primary unresected patients with stage III, IVa, or IV bloco-regionally advanced head and neck squamous cell carcinoma

    Study Document Trial statement 1200.162_DR english Trial synopsis 1200.162 english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.134
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    Phase I trial of afatinib in combination with 3 weekly trastuzumab in patients with tumours overexpressing HER2. Once the MTD of afatinib with 3 weekly trastuzumab was established the safety of this dose will be assessed also in combination with weekly trastuzumab

    Study Document Trial statement 1200.134 english Trial synopsis 1200.134 english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.48
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase IIIb
    Study Title

    An open label trial of afatinib in treatment-naive or chemotherapy pre-treated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s)

    Study Document Trial synopsis 1200.48 english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.208
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase IV
    Study Title

    An open-label, single-arm Phase IV study of afatinib in patients with stage IV or recurrent Non-Small Cell Lung Cancer who have poor performance status and whose tumors have the common epidermal growth factor receptor (EGFR) mutations, Exon 19 deletions or Exon 21(L858R) substitution mutations

    Study Document Trial synopsis 1200.208 english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.181
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase IV
    Study Title

    Post marketing surveillance on long term drug use of GIOTRIF® Tablets in patients with epidermal growth factor receptor (EGFR) mutation-positive inoperable or recurrent non-small cell lung cancer (NSCLC).

    Study Document Trial synopsis 1200.181 english
  • GIOTRIF ® (afatinib) - Breast Neoplasms
    Clinical Study Number 1200.98
    Study Indication Breast Neoplasms
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    LUX-Breast 2: An open-label, phase II trial of BIBW 2992 (afatinib) in patients with metastatic HER2-overexpressing breast cancer failing HER2- targeted treatment in the neoadjuvant and/or adjuvant treatment setting

    Study Document Trial synopsis 1200.98 english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.217
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase IV
    Study Title

    An open-label, single-arm phase IV study to assess the efficacy and safety of afatinib as second-line therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring an EGFR mutation (Del19 or L858R) who have failed first-line treatment with platinum-based chemotherapy

    Study Document Trial synopsis 1200.217 english
  • GIOTRIF ® (afatinib) - Glioma
    Clinical Study Number 1200.38
    Study Indication Glioma
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    Phase I, open label trial to explore safety of combining BIBW 2992 and radiotherapy with or without temozolomide in newly diagnosed GBM

    Study Document Trial synopsis 1200.38 english Lay summary 1200.38 english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.270
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase IV
    Study Title

    RealGiDo: Real-world data on Gi(l)otrif® dose adjustment in first-line treatment, TKI-naïve, advanced non-small cell lung cancer patients with EGFR activating mutations

    Study Document Trial synopsis 1200.270 english

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