Patients with locally advanced, non-resectable and/or metastatic solid tumours.
Conditions
Sponsors
Boehringer Ingelheim Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: •Histologically confirmed diagnosis of malignancy that is now advanced, non-resectable and / or metastatic. •Life expectancy of at least 3 months. •Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0 or 1. •Patients must have recovered from any previous surgery. •Adequate organ function 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
Exclusion criteria
Exclusion criteria: •Active infectious disease •Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol •GI tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease. •Significant cardiovascular disease (a history of congestive heart failure requiring therapy, a need for anti-arrhythmic therapy for a ventricular arrhythmia, unstable angina pectoris or myocardial infarction within 6 months prior to trial entry). •Patients who require full-dose anticoagulation. •Patients not completely recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies to CTC 1.5, abnormal PTT •therapeutic anti-coagulation •squamous non-small cell lung cancer (NSCLC)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: There are two stages to this study: 1) to determine the maximum tolerated dose of BIBW 2992 when given continuously in combination with Paclitaxel given on days 1, 15 and 22 of a 4 week cycle. 2) to determine the maximum tolerated dose of Bevacizumab when given every 14 days in combination with the maximum tolerated dose of BIBW 2992 and Paclitaxel as determined by stage 1.;Secondary Objective: 1) To determine the incidence and intensity of Adverse Events according to the Common Toxicity Criteria (CTC v.3). 2) To examine the pharmacokinetic characteristics of BIBW 2992, Paclitaxel and Bevacizumab when given in combination. 3) To evalulate objective tumour responses after BIBW 2992 treatment. 4) To examine any correlation between Epidermal Growth Factor Receptor (EGFR), Human Epidermal Growth Factor Receptor 2 (HER2), Oestrogen Receptor (ER) and Progesterone Receptor (PrR) status and objective tumour responses.;Primary end point(s): There are two stages to this study and hence two primary endpoints: 1) to determine the maximum tolerated dose of BIBW 2992 when given continuously in combination with Paclitaxel given on days 1, 15 and 22 of a 4 week cycle. 2) to determine the maximum tolerated dose of Bevacizumab when given every 14 days in combination with the maximum tolerated dose of BIBW 2992 and Paclitaxel as determined by stage 1. Each endpoint will be reached when 6 patients have been treated for 28 days at the maximum tolerated dose (where less than 2 of the 6 patients have suffered a dose limiting toxicity). | — |
Countries
United Kingdom
Outcome results
None listed