Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/EUCTR2008-002072-10-NL
EUCTR2008-002072-10-NLActive, not recruitingNot Applicable

Multicenter, randomised, double-blind, Phase III trial to investigate theefficacy and safety of oral BIBF 1120 plus standard pemetrexed therapycompared to placebo plus standard pemetrexed therapy in patients withstage IIIB/IV or recurrent non small cell lung cancer after failure of firstline chemotherapy - BIBF plus Pemetrexed in 2nd line NSCLC patients

Boehringer Ingelheim International GmbH0 sites1,300 target enrollmentStarted: November 4, 2008Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
1,300
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Male or female patient aged 18 years or older
  • •Histologically or cytologically confirmed Stage IIIB, IV (according to AJCC) or
  • •recurrent NSCLC (non squamous histologies)
  • •Relapse or failure of one first line chemotherapy (in the case of recurrent disease one additional prior regimen is allowed for adjuvant ,neoadjuvant or neoadjuvant plus adjuvant therapy)
  • •At least one target tumor lesion that has not been irradiated within the past three
  • •months and that can accurately be measured by magnetic resonance imaging (MRI) or computed tomography (CT) in at least one dimension (longest diameter to be
  • •recorded) as =20 mm with conventional techniques or as =10 mm with spiral CT
  • •Life expectancy of at least three months
  • •ECOG score of 0 or 1
  • •Patient has given written informed consent which must be consistent with the
  • •International Conference on Harmonization – Good Clinical Practice (ICH-GCP) and
  • •local legislation
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •- More than one prior chemotherapy regimen for advanced and/or metastatic disease of NSCLC
  • •- More than one chemotherapy treatment regimen (either neoadjuvant or adjuvant or neoadjvant plus adjuvant) prior to first line chemotherapy of advanced and/or metastatic NSCLC
  • •- Previous therapy with other VEGFR inhibitors (other than bevacizumab) or
  • •pemetrexed for treatment of NSCLC
  • •- Persistence of clinically relevant therapy related toxicities from previous
  • •chemotherapy and/or radiotherapy
  • •- Treatment with other investigational drugs or treatment in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial
  • •- Chemo-, hormone-, immunotherapy or therapy with monoclonal antibodies or small
  • •tyrosine kinase inhibitors within the past four weeks prior to treatment with the trial
  • •drug, i.e., the minimum time elapsed since the last anticancer therapy and the first
  • •administration of BIBF 1120 must be four weeks
  • •- Radiotherapy (except extremities and brain) within the past three months prior to
  • •baseline imaging
  • •- Patients taking NSAIDS with short half lives unable or unwilling to interrupt
  • •NSAIDsS for a five day period (2 days before pemetrexed, day of pemetrexed, 2 days
  • •after pemetrexed)
  • •Patients taking NSAIDS with long half lives must interrupt NSAID for 8 days (5 days
  • •before, day of and 2 days after treatment with pemetrexed)
  • •- Active brain metastases (e.g. stable for < 4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants; dexamethasone therapy will be allowed if administered as stable dose for at least one month before randomisation)
  • •- leptomeningeal disease
  • •- Radiographic evidence of cavitary or necrotic tumors
  • •- Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of
  • •major blood vessels
  • •- History of clinically significant haemoptysis within the past 3 months (more than one tea spoon of fresh blood per day)
  • •- Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except for chronic low-dose therapy with acetylsalicylic acid =?325mg per day)
  • •- History of major thrombotic or clinically relevant major bleeding event in the past
  • •- Known inherited predisposition to bleeding or thrombosis
  • •- Significant cardiovascular diseases (i.e., hypertension not controlled by medical
  • •therapy, unstable angina, history of myocardial infarction within the past 6 months,
  • •congestive heart failure > NYHA II, serious cardiac arrhythmia, pericardial effusion)
  • •- Calculated creatinine clearance by Cockcroft Gault <45ml/min
  • •- Proteinuria CTCAE grade 2 or greater
  • •- Total bilirubin above the upper limit of normal
  • •- ALT and/or AST > 2.5 x upper limit of normal in the presence of live metastasis or
  • •ALT and/or AST >1.5 x upper limit of normal in patients without liver metastasis.
  • •- Prothrombin time and/or partial thromboplastin time greater than 50% deviation from normal limits
  • •- Absolute neutrophil count (ANC) < 1500 neutrophils /mm3
  • •- Platelets < 100,000 platelets/mm
  • •- Haemoglobin < 9.0 g/dL
  • •- Significant weight loss (> 10 %) within the past 6 weeks prior to treatment in the
  • •present trial
  • •Major injuries and/or surgery within the past ten days prior to randomisation with
  • •incomplete wound healing
  • •- Current peripheral neuropathy =?CTCAE grade 2 except due to trauma
  • •- Preexisting ascites and/or clinically significant pleural effusion

Investigators

Similar Trials

Active, not recruiting
Not Applicable
BIBF 1120 plus pemetrexed compared to placebo plus pemetrexed in 2nd line nonsquamous NSCLCStage IIIB/IV or recurrent non small cell lung cancer. non squamous histologyMedDRA version: 14.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2008-002072-10-HUBoehringer Ingelheim International GmbH1,300
Active, not recruiting
Not Applicable
Multicenter, randomised, double-blind, Phase III trial to investigate theefficacy and safety of oral BIBF 1120 plus standard pemetrexed therapycompared to placebo plus standard pemetrexed therapy in patients withstage IIIB/IV or recurrent non small cell lung cancer after failure of firstline chemotherapy - BIBF plus Pemetrexed in 2nd line NSCLC patientsStage IIIB/IV or recurrent non small cell lung cancer. non squamous histologyMedDRA version: 9.1Level: LLTClassification code 10029521Term: Non-small cell lung cancer stage IIIBMedDRA version: 9.1Level: LLTClassification code 10029522Term: Non-small cell lung cancer stage IVMedDRA version: 9.1Level: LLTClassification code 10029515Term: Non-small cell lung cancer recurrent
EUCTR2008-002072-10-ROBoehringer Ingelheim International GmbH1,300
Active, not recruiting
Phase 1
BIBF 1120 plus pemetrexed compared to placebo plus pemetrexed in 2nd line nonsquamous NSCLCStage IIIB/IV or recurrent non small cell lung cancer. non squamous histologyMedDRA version: 14.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2008-002072-10-DEBoehringer Ingelheim International GmbH1,300
Active, not recruiting
Not Applicable
BIBF 1120 plus pemetrexed compared to placebo plus pemetrexed in 2nd line nonsquamous NSCLCStage IIIB/IV or recurrent non small cell lung cancer. non squamous histologyMedDRA version: 16.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.1Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2008-002072-10-PLBoehringer Ingelheim International GmbH1,300
Active, not recruiting
Not Applicable
BIBF 1120 plus pemetrexed compared to placebo plus pemetrexed in 2nd line nonsquamous NSCLC
EUCTR2008-002072-10-LVBoehringer Ingelheim International GmbH1,300