A Dose Escalation Study of BIBF 1120 Together With Paclitaxel and Carboplatin in Patients With Advanced Stage Non-small-cell Lung Cancer

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: Paclitaxel

Drug: BIBF 1120

Drug: Carboplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02182232

1199.5

Details and patient eligibility

About

The primary objectives of this trial were to determine the MTD of BIBF 1120 in combination with carboplatin and paclitaxel, pharmacokinetics and objective response of treatment

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patients with histologically or cytologically confirmed Stage IIIB (including pleural effusion), IV or recurrent NSCLC
Bi-dimensionally measurable disease by one or more techniques (CT, MRI, X-ray)
Age 18 years or older
Life expectancy of at least three (3) months
Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
Written informed consent that is consistent with ICH-GCP guidelines

Exclusion criteria

Prior treatment for NSCLC including chemotherapy, biologic response modifier therapy, or any investigational drug
Participation in another clinical study within the past four weeks before start of therapy or concomitantly with this study
Active brain metastases (stable for <28 days, symptomatic, or requiring concurrent steroids or antiepileptic therapy)
Centrally located tumors with radiologic evidence (CT or MRI) of local invasion of major blood vessels
Cavitary or necrotic tumors
Sanguinous pleural effusion due to disease or pericardial effusion suspicious for disease
Radiotherapy to an area of measurable disease (unless disease progression had been documented following completion of therapy)
Radiotherapy within 4 weeks preceding Day 0
Other active malignancy diagnosed within the past 3 years (other than non-melanomatous skin cancer)
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
Significant cardiovascular disease (i.e., uncontrolled hypertension, myocardial infarction within 6 months, unstable angina, serious cardiac arrhythmia, ≥NYHA Grade 2 congestive heart failure)
History of hemorrhagic or thrombotic event (including transient ischemic attacks) in the past 12 months
Clinically significant hemoptysis (1 teaspoon or more) in the past 3 months
Concurrent therapeutic anticoagulation (except heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except chronic low-dose daily aspirin <325 mg)
Known hypersensitivity to paclitaxel, carboplatin, or any of their excipients including Cremophor® (polyoxyethylated castor oil)
Absolute neutrophil count (ANC) ≤1,500/μl, platelet count ≤100,000/μl, or hemoglobin <9 gm/dL
Total bilirubin >1.5 mg/dL (26 μmol/L, SI Unit equivalent), alanine amino transferase (ALT) and/or aspartate amino transferase (AST) ≥1.5 X ULN,
Serum creatinine >1.5 mg/dL (>132 μmol/L, SI Unit equivalent)
Persistent hematuria or proteinuria (more than trace)
Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
Pregnancy or breastfeeding
Known or suspected active alcohol or drug abuse
Patients unable to comply with the protocol