A double-blind, randomized Phase II study to determine efficacy and safety of oral treatment with BIBF 1120 ES 250 mg twice daily versus 150 mg twice daily in patients suffering from advanced non-small-cell lung cancer. -
- Conditions
- Relapsed non-small-cell lunger cancer patients stage IIIB and stage IV after previous treatment with platinum- or non-platinum based chemotherapyMedDRA version: 7.1Level: PTClassification code 10061873
- Registration Number
- EUCTR2005-000317-35-DE
- Lead Sponsor
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 70
1) Male or female patients with histologically confirmed advanced NSCLC (non-small-cell lung cancer) (i.e. adenocarcinoma, squamous cell carcinoma, large cell carcinoma, or combinations of these) stage IIIB (including pleural effusion) and stage IV.
2) Patients with recurrent disease who relapsed after previous treatment with platinum- or non-platinum based chemotherapy.
3) Full recovery from all therapy related toxicities from previous chemotherapy / radiotherapy or recovery in as much as no further improvement may be expected by the investigator.
4) Age 18 years or older
5) Life expectancy of at least 3 months
6) Eastern Cooperative Oncology Group (ECOG) performance score 0, 1 or 2.
7) Bi-dimensionally measurable tumour lesions by one or more techniques (CT, MRI, X-ray).
8) Adequate hepatic function: total bilirubin within normal limits; ALT and/or AST equal or less than 1.5 times upper limit of normal (ULN) in patients without liver metastasis.
For patients with liver metastasis: total bilirubin equal or less than 1.5 times ULN; ALT and/or AST less than 2.5 times ULN.
9) Coagulation parameters: interantional normalised ratio less than 1.3 or prothrombin time (PT) and partial thromboplastin time (PTT) less than 1.5 times institutional ULN.
10) Adequate renal function: serum creatinine equal or less than 1.5 times upper normal limit.
11) Absolute neutrophil count (ANC) equal or more than 1500/mL, platelets equal or more than 100,000/mL, haemoglobin equal or more than 9.0 g/dL.
12) Written informed consent consistent with ICH-GCP guidelines and local law.
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
1) Active brain metastases stable for less than 4 weeks, symptomatic, or requiring treatment with anti-convulsants and/or steroids or leptomeningeal disease.
2) Patients with history of haemorrhagic or thrombotic event (including transient ischemic attacks) in the past 12 months. Known inherited predisposition to thrombosis.
3) Concurrent therapeutic anticoagulation (except heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except chronic low-dose acetylsalicylic acid less than 325 mg).
4) Sanguineous pleural effusion due to disease or pericardial effusion suspicious for disease.
5) Clinically significant haemoptysis (1 teaspoon or more) within the last 3 months.
6) Centrally located tumours with radiographic evidence (CT or MRI) of local invasion of major blood vessels.
7) Radiographic evidence of cavitary or necrotic tumours at screening.
8) Major injuries and surgeries. Planned surgical procedures during the trial. Patients with incomplete wound healing within the past 4 weeks.
9) Gross haematuria with the last 3 months.
10) Significant cardiovascular diseases (i.e. uncontrolled hypertension, instable angina, history of myocardial infarction with the past 6 months, serious cardiac arrhythmia, congestive heart failure according NYHA III or IV (New York Heart Association).
11) Serious illness or concomitant non-oncological disease such as neurologic-, psychiatric- or infectious disease or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgement of the investigator would make the patient inappropriate for entry into the study.
12) Gastrointestinal abnormalities that would interfere with intake or absorption of the study drug, prior surgical procedures affecting absorption, treatment for peptic ulcer disease within the last 6 months, active gastrointestinal bleeding unrelated to cancer (as evidenced by either hematemesis, hematochezia, or melena in the past 3 months and without endoscopic documented resolution), or malabsorption syndromes.
13) Other malignancy within the past 5 years (other than non-melanomatous skin cancer or cervical carcinoma in situ).
14) Treatment with other investigational drugs (elimination half life less than 5 days) within the past 4 weeks before visit 2 or participation in another clinical trial within the past 4 weeks before start of therapy (visit 2) or concomitantly with this trial.
15) Treatment with chemo-, immuno-, or homornetherapy or with biologic response modifier within the past 4 weeks prior to treatmetn with the trial drug and during the trial.
16) Radiotherapy within the last 4 weeks prior start of treatment with the trial drug and radiotherapy to an area of measurable disease.
17) Hypersensitivity to BIBF 1120 ES or the excipients of the trial drug.
18) Male and female patients who are sexually active and unwilling to use a medically acceptable method of contraception prior to study entry and for the duration of study participation.
19) Pregnancy or breast feeding.
20) Known or suspected alcohol or drug abuse.
21) Patients unable to comply with the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method