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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00801294 |
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.
Condition | Intervention | Phase |
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Colorectal Neoplasms |
Drug: BIBF 1120 and BIBW 2992 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial of Weekly Alternating Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Advanced Colorectal Cancer |
Enrollment: | 46 |
Study Start Date: | July 2006 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
1239.2.3301A Hôpital Saint Antoine | |
Paris Cedex 12, France | |
1239.2.3302A Hôpital Tenon | |
Paris Cedex 20, France | |
1239.2.3303A Institut Gustave Roussy | |
Villejuif Cedex, France | |
1239.2.3304A Hôpital Robert Debré | |
Reims Cedex, France | |
1239.2.3305A clinique Saint Jean | |
Lyon, France | |
1239.2.3301B Hôpital Saint Antoine | |
Paris Cedex 12, France | |
1239.2.3301C Hôpital Saint Antoine | |
Paris Cedex 12, France | |
1239.2.3301D Hôpital Saint Antoine | |
Paris Cedex 12, France | |
1239.2.3301E Hôpital Saint Antoine | |
Paris Cedex 12, France | |
1239.2.3302B Hôpital Tenon | |
Paris Cedex 20, France | |
1239.2.3303B Institut Gustave Roussy | |
Villejuif Cedex, France | |
1239.2.3303C Institut Gustave Roussy | |
Villejuif Cedex, France | |
1239.2.3301K Hôpital Saint Antoine | |
Paris Cedex 12, France | |
1239.2.3303E Institut Gustave Roussy | |
Villejuif Cedex, France | |
1239.2.3303F Institut Gustave Roussy | |
Villejuif Cedex, France | |
1239.2.3304B Hôpital Robert Debré | |
Reims Cedex, France | |
1239.2.3304C Hôpital Robert Debré | |
Reims Cedex, France | |
1239.2.3305B Cabinet Médical | |
Lyon, France | |
1239.2.3301F Hôpital Saint Antoine | |
Paris Cedex 12, France | |
1239.2.3301G Hôpital Saint Antoine | |
Paris Cedex 12, France | |
1239.2.3301H Hôpital Saint Antoine | |
Paris Cedex 12, France | |
1239.2.3301I Hôpital Saint Antoine | |
Paris Cedex 12, France | |
1239.2.3301J Hôpital Saint Antoine | |
Paris Cedex 12, France | |
1239.2.3303D Institut Gustave Roussy | |
Villejuif Cedex, France |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1239.2, EudraCT 2006-000893-56 |
Study First Received: | December 2, 2008 |
Last Updated: | April 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00801294 History of Changes |
Health Authority: | France: AFFSAPS; United States: Food and Drug Administration |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Gastrointestinal Neoplasms |
Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |