The primary objective of this trial is to explore the overall objective best response rate and the rate of non-progression at 16 weeks of sequential, alternating weekly administration of BIBF 1120 and BIBW 2992 in patients with metastatic CRC based on the RECIST criteria.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
46
1239.2.3305A clinique Saint Jean
Lyon, France
1239.2.3305B Cabinet Médical
The RECIST criterion will be used to assess: objective response rate (PR + CR), and disease progression within the first 16 weeks
Time frame: every 4 weeks
PFS
Time frame: 16 weeks
Progression-free survival (based on the RECIST criteria)
Time frame: 66 Weeks
Overall survival
Time frame: 66 Weeks
The incidence and intensity of Adverse Events with grading of Adverse Events according to the US NCI Common Terminology Criteria for Adverse Events (CTCAE version 3.0)
Time frame: 66 Weeks
Changes in safety laboratory parameters
Time frame: 66 Weeks
Effectiveness of dose reduction guidelines in managing adverse events
Time frame: 66 Weeks
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Lyon, France
1239.2.3301A Hôpital Saint Antoine
Paris, France
1239.2.3301B Hôpital Saint Antoine
Paris, France
1239.2.3301C Hôpital Saint Antoine
Paris, France
1239.2.3301D Hôpital Saint Antoine
Paris, France
1239.2.3301E Hôpital Saint Antoine
Paris, France
1239.2.3301F Hôpital Saint Antoine
Paris, France
1239.2.3301G Hôpital Saint Antoine
Paris, France
1239.2.3301H Hôpital Saint Antoine
Paris, France
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