Clareo Health | A Dose Escalation Study of BIBF 1120 Together With Paclitaxel and Carboplatin in Patients With Advanced Stage Non-small-cell Lung Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Male or female patients with histologically or cytologically confirmed Stage IIIB (including pleural effusion), IV or recurrent NSCLC
2. Bi-dimensionally measurable disease by one or more techniques (CT, MRI, X-ray)
3. Age 18 years or older
4. Life expectancy of at least three (3) months
5. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
6. Written informed consent that is consistent with ICH-GCP guidelines
You may not be if
1. Prior treatment for NSCLC including chemotherapy, biologic response modifier therapy, or any investigational drug
2. Participation in another clinical study within the past four weeks before start of therapy or concomitantly with this study
3. Active brain metastases (stable for \<28 days, symptomatic, or requiring concurrent steroids or antiepileptic therapy)
4. Centrally located tumors with radiologic evidence (CT or MRI) of local invasion of major blood vessels
5. Cavitary or necrotic tumors
6. Sanguinous pleural effusion due to disease or pericardial effusion suspicious for disease
7. Radiotherapy to an area of measurable disease (unless disease progression had been documented following completion of therapy)
8. Radiotherapy within 4 weeks preceding Day 0
9. Other active malignancy diagnosed within the past 3 years (other than non-melanomatous skin cancer)
10. Gastrointestinal abnormalities that would interfere with intake or absorption of the study drug, such as a requirement for intravenous alimentation, 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
