Know Cancer

or
forgot password

Multicentre, Randomised, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral BIBF 1120 Plus Standard Docetaxel Therapy Compared to Placebo Plus Standard Docetaxel Therapy in Patients With Stage IIIB/IV or Recurrent Non Small Cell Lung Cancer After Failure of First Line Chemotherapy


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

Multicentre, Randomised, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral BIBF 1120 Plus Standard Docetaxel Therapy Compared to Placebo Plus Standard Docetaxel Therapy in Patients With Stage IIIB/IV or Recurrent Non Small Cell Lung Cancer After Failure of First Line Chemotherapy

Inclusion Criteria


Inclusion criteria:

- male or female patient aged 18 years or older;

- histologically or cytologically confirmed, locally advanced and/or metastatic NSCLC
of stage IIIB or IV or recurrent NSCLC;

- relapse or failure of one first line prior chemotherapy;

- at least one target tumour lesion that has not been irradiated within the past three
months and that can accurately be measured ;

- life expectancy of at least three months;

- ECOG score of 0 or 1;

- patient has given written informed consent

Exclusion criteria:

- more than one prior chemotherapy regimen for advanced and/or metastatic or recurrent
NSCLC;

- more than one chemotherapy treatment regimen (either neoadjuvant or adjuvant or
neoadjuvant plus adjuvant) prior to first line chemotherapy;

- previous therapy with other VEGFR inhibitors (other than bevacizumab) or docetaxel
for treatment of NSCLC;

- persistence of clinically relevant therapy related toxicities from previous
chemotherapy and/or radiotherapy;

- treatment with other investigational drugs or other anti-cancer therapy or treatment
in another clinical trial within the past four weeks before start of - therapy or
concomitantly with this trial ;

- radiotherapy (except extremities and brain) within the past three months prior to
baseline imaging;

- active brain metastases or leptomeningeal disease;

- radiographic evidence of cavitary or necrotic tumours;

- centrally located tumours with radiographic evidence (CT or MRI) of local invasion of
major blood vessels;

- history of clinically significant haemoptysis within the past 3 months;

- therapeutic anticoagulation (except low dose heparin) or antiplatelet therapy;

- history of major thrombotic or clinically relevant major bleeding event in the past 6
months;

- known inherited predisposition to bleeding or thrombosis;

- significant cardiovascular diseases ;

- inadequate safety laboratory parameters;

- significant weight loss (> 10 %) within the past 6 weeks;

- current peripheral neuropathy greater than CTCAE grade 2 except due to trauma;

- preexisting ascites and/or clinically significant pleural effusion;

- major injuries and/or surgery within the past ten days prior to randomisation with
incomplete wound healing;

- serious infections requiring systemic antibiotic therapy;

- decompensated diabetes mellitus or other contraindication to high dose corticosteroid
therapy;

- gastrointestinal disorders or abnormalities that would interfere with absorption of
the study drug;

- active or chronic hepatitis C and/or B infection;

- serious illness or concomitant non-oncological disease or laboratory abnormality that
may increase the risk associated with study participation or study drug
administration;

- patients who are sexually active and unwilling to use a medically acceptable method
of contraception during the trial and for at least twelve months after end of active
therapy;

- pregnancy or breast feeding;

- psychological, familial, sociological or geographical factors potentially hampering
compliance with the study protocol and follow-up schedule;

- patients unable to comply with the protocol;

- active alcohol or drug abuse;

- other malignancy within the past three years other than basal cell skin cancer, or
carcinoma in situ of the cervix;

- any contraindications for therapy with docetaxel;

- history of severe hypersensitivity reactions to docetaxel or other drugs formulated
with polysorbate 80 (Tween 80);

- hypersensitivity to BIBF 1120 and/or the excipients of the trial drugs;

- hypersensitivity to contrast media

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

progression free survival

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

Austria: Agency for Health and Food Safety

Study ID:

1199.13

NCT ID:

NCT00805194

Start Date:

December 2008

Completion Date:

December 2013

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location