Value through Innovation27 July 2016

Clinical Study Results

  • VARGATEF ® - Ovarian Neoplasms
    Clinical Study Number 1199.15
    Study Indication Ovarian Neoplasms
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase IIIa
    Study Title

    Multicenter, randomised, double-blind Phase III trial to investigate the efficacy and safety of BIBF 1120 in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in patients with advanced ovarian cancer

    Study Document Trial synopsis 1199.15 english Lay summary 1199.15 english
  • VARGATEF ® - Ovarian Neoplasms
    Clinical Study Number 1199.9
    Study Indication Ovarian Neoplasms
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase II
    Study Title

    A randomised placebo-controlled phase II study of continuous maintenance treatment with BIBF 1120 following chemotherapy in patients with relapsed ovarian cancer

    Study Document Trial synopsis 1199.9_DS_DR english
  • VARGATEF ® - Prostatic Neoplasms
    Clinical Study Number 1199.11
    Study Indication Prostatic Neoplasms
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase IIa
    Study Title

    Phase II trial of two dose levels BIBF 1120 in patients with advanced prostate cancer

    Study Document Trial synopsis 1199.11 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 ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.29
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I study of continuous, concomitant oral treatment with BIBF 1120 and docetaxel - a Phase I, open-label, dose-escalation study in Japanese patients with stage IIIB/IV or recurrent non-small-cell lung cancer after failure of chemotherapy

    Study Document Trial synopsis 1199.29 english
  • VARGATEF ® - Colorectal Neoplasms
    Clinical Study Number 1199.51
    Study Indication Colorectal Neoplasms
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I/II
    Study Title

    A phase I-II study of BIBF 1120 and Folfox compared to Bevacizumab and Folfox in first line metastatic colorectal cancer patients

    Study Document Trial synopsis 1199.51_DR english
  • VARGATEF ® - Ovarian Neoplasms
    Clinical Study Number 1199.117
    Study Indication Ovarian Neoplasms
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    An open label, dose escalation phase I study of the safety and tolerability of BIBF 1120 in combination with carboplatin and pegylated liposomaldoxorubicin (PLD) in Japanese patients with a first, second or third platinum sensitive relapse of advanced epithelial ovarian cancer (OC), fallopian tube or primary peritoneal cancer 

    Study Document Trial synopsis 1199.117_DR english
  • VARGATEF ® - Healthy
    Clinical Study Number 1199.161
    Study Indication Healthy
    Product OFEV ® ; VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of nintedanib given alone and in combination with ketoconazole at steady state in healthy male volunteers (an open-label, randomised, two-way cross-over clinical Phase I study)

    Study Document Trial synopsis 1199.161_DS_DR english
  • VARGATEF ® - Healthy
    Clinical Study Number 1199.162
    Study Indication Healthy
    Product OFEV ® ; VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of a single oral dose of nintedanib given alone and in combination with multiple oral doses of rifampicin in healthy male volunteers (an open-label, two-period, fixed-sequence clinical Phase I trial)

    Study Document Trial synopsis 1199.162_DS_DR english
  • VARGATEF ® - Ovarian Neoplasms
    Clinical Study Number 1199.119
    Study Indication Ovarian Neoplasms
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    Phase I dose escalation trial to determine the maximum tolerated dose of BIBF 1120 in combination with carboplatin and pegylated liposomal doxorubicin (PLD) in patients with a first, second or third platinum sensitive relapse of advanced epithelial ovarian cancer, fallopian tube or primary peritoneal cancer

    Study Document Trial synopsis 1199.119_primary_anal english Trial synopsis 1199.119_final english Lay summary 1199.119 english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.10
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase IIa
    Study Title

    Phase II trial of BIBF 1120 in patients with stage IIIB/IV non small cell lung cancer

    Study Document Trial synopsis 1199.10 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 ® - Multiple Myeloma
    Clinical Study Number 1199.2
    Study Indication Multiple Myeloma
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase Ib
    Study Title

    Phase I dose escalation in patients with refractory multiple myeloma

    Study Document Trial synopsis 1199.2_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 ® - Prostatic Neoplasms
    Clinical Study Number 1199.4
    Study Indication Prostatic Neoplasms
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase Ib
    Study Title

    Phase I study of escalating doses of BIBF 1120 ES with docetaxel in patients with hormone refractory prostate cancer

    Study Document Trial synopsis 1199.4 english
  • VARGATEF ® - Genital Neoplasms, Female
    Clinical Study Number 1199.6
    Study Indication Genital Neoplasms, Female
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    Phase I trial of escalating doses of BIBF 1120 in combination with paclitaxel/carboplatin in patients with advanced gynaecological malignancies

    Study Document Trial synopsis 1199.6 english
  • VARGATEF ® - Healthy
    Clinical Study Number 1199.17
    Study Indication Healthy
    Product OFEV ® ; VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase Ia
    Study Title

    Safety and pharmacokinetics/bioavailability of a single dose of 150 mg BIBF 1120 administered as soft gelatine capsules with and without food to healthy male volunteers in an open, randomised intra-individual crossover comparison design

    Study Document Trial synopsis 1199.17 english
  • VARGATEF ® - Healthy
    Clinical Study Number 1199.20
    Study Indication Healthy
    Product OFEV ® ; VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    Metabolism and pharmacokinetics of [14C]-BIBF 1120 after administration of single doses of 100 mg [14C]-BIBF 1120 oral solution in healthy male volunteers

    Study Document Trial synopsis 1199.20_CO english
  • VARGATEF ® - Healthy
    Clinical Study Number 1199.21
    Study Indication Healthy
    Product OFEV ® ; VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    Safety and relative bioavailability of a single dose of 150 mg BIBF 1120 administered as soft gelatine capsules charge 1 compared to BIBF 1120 soft gelatine capsules charge 2 compared to BIBF 1120 administered as drinking solution following oral administration to healthy male volunteers in an open, randomised, intra-individual, crossover comparison design

    Study Document Trial synopsis 1199.21_CO english
  • VARGATEF ® - Healthy
    Clinical Study Number 1199.75
    Study Indication Healthy
    Product OFEV ® ; VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    Safety and tolerability of single rising doses of 1 mg, 3 mg, 10 mg and 20 mg of BIBF 1120 as intravenous infusion (single-blind, placebo controlled at each dose group) and absolute bioavailability of 100 mg BIBF 1120 as soft gelatine capsule (intra-individual comparison)

    Study Document Trial synopsis 1199.75 english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.5
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase Ib
    Study Title

    A Phase I open label dose escalation study of continuous oral treatment with BIBF 1120 together with paclitaxel and carboplatin in patients with advanced stage non-small-cell lung cancer

    Study Document Trial synopsis 1199.5_CO english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.18
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I open label study of continuous oral treatment with BIBF 1120 ES together with pemetrexed in previously treated patients with non-small cell lung cancer

    Study Document Trial synopsis 1199.18_CO 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
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.13
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase III
    Study Title

    Multicentre, randomised, double-blind, Phase III trial to investigate the efficacyand safety of oral BIBF 1120 plus standard docetaxel therapy compared toplacebo plus standard docetaxel therapy in patients with stage IIIB/IV orrecurrent non small cell lung cancer after failure of first line chemotherapy(LUME Lung 1)

    Study Document Trial synopsis 1199.13 english Lay summary 1199.13 english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.14
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase III
    Study Title

    Multicentre, randomized, double-blind, Phase III trial to investigate the efficacy and safety of oral BIBF 1120 plus standard pemetrexed therapy compared to placebo plus standard pemetrexed therapy in patients with stage IIIB/IV or recurrent non-small cell lung cancer after failure of first-line chemotherapy (LUME Lung 2)

    Study Document Trial synopsis 1199.14_PE_DS_DR english Trial synopsis 1199.14_FU english
  • VARGATEF ® - Carcinoma, Hepatocellular
    Clinical Study Number 1199.39
    Study Indication Carcinoma, Hepatocellular
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I/II
    Study Title

    A multicenter, open label, phase I/randomized II study to evaluate safety, pharmacokinetics and efficacy of BIBF 1120 in comparison with sorafenib for advanced hepatocellular carcinoma patients in Asia.

    Study Document Trial synopsis 1199.39 english
  • VARGATEF ® - Carcinoma, Hepatocellular
    Clinical Study Number 1199.37
    Study Indication Carcinoma, Hepatocellular
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I/II
    Study Title

    A multicentre, open label, Phase I/randomised Phase II study to evaluate safety, pharmacokinetics and efficacy of BIBF 1120 in comparison with sorafenib for advanced hepatocellular carcinoma patients

    Study Document Trial synopsis 1199.37 english
  • VARGATEF ® - Carcinoma, Hepatocellular
    Clinical Study Number 1199.120
    Study Indication Carcinoma, Hepatocellular
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    An open label, dose escalation phase I study to evaluate the safety and tolerability of continuous twice-daily oral treatment of nintedanib in Japanese patients with hepatocellular carcinoma

    Study Document Trial synopsis 1199.120_DR english
  • VARGATEF ® - Hepatic Insufficiency
    Clinical Study Number 1199.200
    Study Indication Hepatic Insufficiency
    Product OFEV ® ; VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, safety and tolerability of nintedanib single oral dose in male and female patients with different degrees of hepatic impairment (Child-Pugh classification A and B) as compared with nintedanib administration to male and female healthy subjects (a non-blinded, parallel group study of Phase I)

    Study Document Trial synopsis 1199.200 english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.28
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I/II
    Study Title

    A phase I/II study of continuous, concomitant oral treatment with BIBF 1120 and pemetrexed - a phase I, open-label, dose-escalation study - a phase II, 2 arm, randomised, double-blind, placebo-controlled study in Japanese patients with stage IIIB/IV or recurrent non-small-cell lung cancer after failure of chemotherapy

    Study Document Trial synopsis 1199.28 english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.128
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase III
    Study Title

    Multicentre, randomised, double-blind, Phase III trial to investigate the efficacy and safety of oral nintedanib plus docetaxel therapy compared to placebo plus docetaxel therapy in patients with stage IIIB/IV or recurrent, adenocarcinoma subtype non-small cell lung cancer after failure of first line chemotherapy

    Study Document Trial statement 1199.128_DR english Trial synopsis 1199.128_PR english
  • VARGATEF ® - Healthy
    Clinical Study Number 1199.237
    Study Indication Healthy
    Product OFEV ® ; VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of 1 soft gelatine capsule containing 200 mg nintedanib compared to 2 soft gelatine capsules containing 100 mg nintedanib following oral administration in healthy male subjects

    Study Document Trial synopsis 1199.237 english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.90
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase Ib
    Study Title

    An open label Phase I safety run-in trial of oral nintedanib plus docetaxel therapy in Japanese patients with locally advanced or metastatic adenocarcinoma subtype non-small cell lung cancer after failure of platinum-based first line chemotherapy

    Study Document Trial synopsis 1199.90 english
  • VARGATEF ® - Healthy
    Clinical Study Number 1199.239
    Study Indication Healthy
    Product OFEV ® ; VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    Influence of bosentan on the pharmacokinetics of nintedanib in healthy male subjects

    Study Document Trial synopsis 1199.239 english
  • VARGATEF ® - Mesothelioma
    Clinical Study Number 1199.93
    Study Indication Mesothelioma
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase II/III
    Study Title

    LUME-Meso: Double blind, randomised, multicentre, phase II/III study of nintedanib in combination with pemetrexed/cisplatin followed by continuing nintedanib monotherapy vs. placebo in combination with pemetrexed/cisplatin followed by continuing placebo monotherapy for the treatment of patients with unresectable malignant pleural mesothelioma

    Study Document Trial synopsis 1199.93_Overall_survival_PhaseII english
  • VARGATEF ® - Colorectal Neoplasms
    Clinical Study Number 1199.52
    Study Indication Colorectal Neoplasms
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase III
    Study Title

    A double-blind, randomised, placebo controlled Phase III study of nintedanib plus best supportive care (BSC) versus placebo plus BSC in patients with colorectal cancer refractory to standard therapies

    Study Document Trial synopsis 1199.52_PR english Lay summary 1199.52 english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.82
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I/II
    Study Title

    LUME-Lung 3: A Phase I/II study of continuous oral treatment with BIBF 1120 added to standard gemcitabine/cisplatin therapy in first-line NSCLC patients with squamous cell histology

    Study Document Trial synopsis 1199.82 english
  • VARGATEF ® - Colorectal Neoplasms
    Clinical Study Number 1199.251
    Study Indication Colorectal Neoplasms
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase II
    Study Title

    LUME-Colon 2: An open-label randomized phase II study to assess the efficacy and safety of nintedanib alone or in combination with capecitabine for patients with refractory metastatic colorectal cancer

    Study Document Trial synopsis 1199.251 english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.238
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I trial to investigate the effect of nintedanib on the pharmacokinetics of a combination of ethinylestradiol and levonorgestrel in patients with nonsmall cell lung cancer

    Study Document Trial synopsis 1199.238 english Lay summary 1199.238 english

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