Phase I Dose Escalation Study of Concomitant BIBF 1120 and BIBW 2992 in Patients With Advanced Solid Tumours.
The primary objective of this trial is to determine the Maximum Tolerated Dose (MTD) of the combination of BIBW 2992/BIBF 1120 therapy administered concomitantly. The MTD will provide dosing recommendation for subsequent phase II trials in patients with metastatic cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Dose Escalation Study of Concomitant BIBF 1120 and BIBW 2992 in Patients With Advanced Solid Tumours.|
- The primary endpoint of this trial is the assessment of the incidence of Dose Limiting Toxicity (DLT) in the combination BIBW 2992 and BIBF 1120 when administered concomitantly and this incidence will be used to determine the Maximum Tolerated Dose (MTD) [ Time Frame: 28-day ] [ Designated as safety issue: No ]
- Overall response rate according to the Response Evaluation Criteria In Solid Tumours/RECIST [ Time Frame: 28-day ] [ Designated as safety issue: No ]
- Incidence and intensity of all adverse events according to CTCAE (version 3.0). [ Time Frame: 60-months ] [ Designated as safety issue: No ]
- Changes in safety clinical laboratory parameters evaluation [ Time Frame: 60-months ] [ Designated as safety issue: No ]
- Determination of pharmacokinetic characteristics of BIBF1120 and BIBW 2992 [ Time Frame: 28-day ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: BIBW 2992 + BIBF 1120
This is a phase I dose escalation clinical trial and the data obtained shall determine the MTD for the combination of BIBW 2992/BIBF 1120 in 28-day of treatment.
Drug: BIBW 2992
EGFR inhibitorDrug: BIBF 1120
Please refer to this study by its ClinicalTrials.gov identifier: NCT00998296
|1239.14.3301A Boehringer Ingelheim Investigational Site|
|Villejuif Cedex, France|
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|