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A Randomized Double-blind Multicenter Phase III Trial of BIBF 1120 Plus Pemetrexed vs. Pemetrexed/ Placebo in Advanced or Recurrent Non Small Cell Lung Cancer Patients After Failure of First Line Therapy


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

Thank you

Trial Information

A Randomized Double-blind Multicenter Phase III Trial of BIBF 1120 Plus Pemetrexed vs. Pemetrexed/ Placebo in Advanced or Recurrent Non Small Cell Lung Cancer Patients After Failure of First Line Therapy

Inclusion Criteria


Inclusion criteria:

1. Male or female patient aged 18 years or older.

2. Histologically or cytologically confirmed Stage IIIB, IV (according to AJCC) or
recurrent NSCLC (non squamous histologies)

3. 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).

4. 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 greater than or equal to 20 mm with conventional techniques or as greater than or
equal to 10 mm with spiral CT.

5. Life expectancy of at least three months.

6. ECOG score of 0 or 1.

7. Patient has given written informed consent which must be consistent with the
International Conference on Harmonization, Good Clinical Practice (ICH-GCP) and local
legislation.

Exclusion criteria:

1. Previous therapy with other VEGF inhibitors (other than bevacizumab) or pemetrexed
for treatment of NSCLC

2. 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

3. Chemotherapy, hormone therapy, immunotherapy with monoclonal antibodies, treatment
with tyrosine kinase inhibitors, or radiotherapy (except for treatment of brain and
extremities) 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

4. Inability to stop intake of NSAIDS (non steroidal anti inflammatory drugs) for
several days

5. 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)

6. Radiographic evidence of cavitary or necrotic tumors

7. Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of
major blood vessels

8. History of clinically significant haemoptysis within the past 3 months

9. Therapeutic anticoagulation

10. History of major thrombotic or clinically relevant major bleeding event in the past 6
months

11. Significant cardiovascular diseases (i.e., hypertension not controlled by medical
therapy, unstable angina, history of myocardial infarction within the past 6 months,

12. Inadequate kidney, liver, blood clotting function

13. Inadequate blood count

14. Significant weight loss (> 10 %) within the past 6 weeks prior to treatment in the
present trial

15. Current peripheral neuropathy greater than or equal to CTCAE Grade 2 except due to
trauma

16. Pre-existing ascites (abdominal fluid collection) and/or clinically significant
pleural effusion ( fluid collection between the lung and chest wall)

17. Major injuries and/or surgery within the past ten days prior to start of study drug

18. Incomplete wound healing

19. Active or chronic hepatitis C and/or B infection

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/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:

Argentina: Ministry of Health

Study ID:

1199.14

NCT ID:

NCT00806819

Start Date:

December 2008

Completion Date:

December 2013

Related Keywords:

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

Name

Location

1199.14.1092 Boehringer Ingelheim Investigational SiteDowny, California  
1199.14.1093 Boehringer Ingelheim Investigational SiteFountain Valley, California  
1199.14.1164 Boehringer Ingelheim Investigational SiteFullerton, California  
1199.14.1181 Boehringer Ingelheim Investigational SiteLong Beach, California  
1199.14.1080 Boehringer Ingelheim Investigational SiteMeriden, Connecticut  
1199.14.1199 Boehringer Ingelheim Investigational SiteAventura, Florida  
1199.14.1194 Boehringer Ingelheim Investigational SiteBoynton Beach, Florida  
1199.14.1160 Boehringer Ingelheim Investigational SiteJacksonville, Florida  
1199.14.1061 Boehringer Ingelheim Investigational SiteMiami, Florida  
1199.14.1057 Boehringer Ingelheim Investigational SiteNew Port Richey, Florida  
1199.14.1054 Boehringer Ingelheim Investigational SitePort St. Lucie, Florida  
1199.14.1055 Boehringer Ingelheim Investigational SiteStuart, Florida  
1199.14.1188 Boehringer Ingelheim Investigational SiteGalesburg, Illinois  
1199.14.1261 Boehringer Ingelheim Investigational SiteSkokie, Illinois  
1199.14.1196 Boehringer Ingelheim Investigational SiteIndianapolis, Indiana  
1199.14.1152 Boehringer Ingelheim Investigational SiteIndianapolis, Indiana  
1199.14.1058 Boehringer Ingelheim Investigational SiteNew Albany, Indiana  
1199.14.1097 Boehringer Ingelheim Investigational SiteWitchita, Kansas  
1199.14.1079 Boehringer Ingelheim Investigational SiteAshland, Kentucky  
1199.14.1172 Boehringer Ingelheim Investigational SiteLouisville, Kentucky  
1199.14.1051 Boehringer Ingelheim Investigational SiteBurlington, Massachusetts  
1199.14.1182 Boehringer Ingelheim Investigational SiteSpringfield, Massachusetts  
1199.14.1098 Boehringer Ingelheim Investigational SiteSt. Louis park, Minnesota  
1199.14.1086 Boehringer Ingelheim Investigational SiteGrand Island, Nebraska  
1199.14.1094 Boehringer Ingelheim Investigational SiteFarmington, New Mexico  
1199.14.1165 Boehringer Ingelheim Investigational SiteDunkirk, New York  
1199.14.1099 Boehringer Ingelheim Investigational SiteGoshen, New York  
1199.14.1256 Boehringer Ingelheim Investigational SiteLake Success, New York  
1199.14.1151 Boehringer Ingelheim Investigational SiteNyack, New York  
1199.14.1254 Boehringer Ingelheim Investigational SiteAsheville, North Carolina  
1199.14.1174 Boehringer Ingelheim Investigational SiteCanton, Ohio  
1199.14.1071 Boehringer Ingelheim Investigational SiteSandusky, Ohio  
1199.14.1179 Boehringer Ingelheim Investigational SiteEphrata, Pennsylvania  
1199.14.1065 Boehringer Ingelheim Investigational SiteLanghorne, Pennsylvania  
1199.14.1169 Boehringer Ingelheim Investigational SitePhiladelphia, Pennsylvania  
1199.14.1056 Boehringer Ingelheim Investigational SiteGermantown, Tennessee  
1199.14.1096 Boehringer Ingelheim Investigational SiteAmarillo, Texas  
1199.14.1158 Boehringer Ingelheim Investigational SiteSeattle, Washington  
1199.14.1259 Boehringer Ingelheim Investigational SiteSpokane, Washington  
1199.14.1186 Boehringer Ingelheim Investigational SiteMadison, Wisconsin  
1199.14.1088 Boehringer Ingelheim Investigational SiteMilwaukee, Wisconsin