A Phase II Trial of Weekly Alternating Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Advanced Colorectal Cancer
2 other identifiers
interventional
46
1 country
24
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 2, 2008
CompletedFirst Posted
Study publicly available on registry
December 3, 2008
CompletedDecember 29, 2017
December 1, 2017
1.3 years
December 2, 2008
December 28, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
The RECIST criterion will be used to assess: objective response rate (PR + CR), and disease progression within the first 16 weeks
every 4 weeks
PFS
16 weeks
Secondary Outcomes (5)
Progression-free survival (based on the RECIST criteria)
66 Weeks
Overall survival
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)
66 Weeks
Changes in safety laboratory parameters
66 Weeks
Effectiveness of dose reduction guidelines in managing adverse events
66 Weeks
Interventions
Eligibility Criteria
You may qualify if:
- Age over 18 years.
- Signed informed consent.
- Histologically proven colorectal adenocarcinoma
- History or presence of metastatic colorectal cancer (stage IV)
- Measurable (\>1 cm) or evaluable tumour deposit (according to RECIST criteria)
- Documented progression or unacceptable toxicity on the last therapy
- Progression on oxaliplatin-based chemotherapy or unacceptable residual neurotoxicity on oxaliplatin
- Progression on irinotecan-based chemotherapy or unacceptable toxicity on irinotecan
- If patients have been previously exposed to Cetuximab or other EGFR inhibitor, they must have shown progression or unacceptable toxicity
- If patients have been previously exposed to Bevacizumab or other VEGF inhibitor, they must have shown progression or unacceptable toxicity
- Life expectancy of at least 12 weeks.
- WHO (ECOG) performance status \<= 2, \<= 1 if age \> 75 years.
- Adequate hepatic function
- Adequate renal function
You may not qualify if:
- Prior treatment with small molecule EGFR, HER2 or VEGFR tyrosine kinase inhibitors
- Treatment with standard chemotherapy or cetuximab within the last 14 days
- Treatment with bevacizumab within the last 28 days
- History of other malignancies in the last 5 years, which could affect compliance with the protocol or interpretation of results. Patients with adequately treated basal or squamous cell skin cancer are generally eligible.
- Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality
- Significant cardiovascular diseases
- History of haemorrhagic or thrombotic event in the past 12 months. Known inherited predisposition to bleeds or to thrombosis.
- Patient with history or clinical or radiological evidence of CNS disease or brain metastases.
- Pregnancy or breast-feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
1239.2.3305A clinique Saint Jean
Lyon, France
1239.2.3305B Cabinet Médical
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
1239.2.3301I Hôpital Saint Antoine
Paris, France
1239.2.3301J Hôpital Saint Antoine
Paris, France
1239.2.3301K Hôpital Saint Antoine
Paris, France
1239.2.3302A Hôpital Tenon
Paris, France
1239.2.3302B Hôpital Tenon
Paris, France
1239.2.3304A Hôpital Robert Debré
Reims, France
1239.2.3304B Hôpital Robert Debré
Reims, France
1239.2.3304C Hôpital Robert Debré
Reims, France
1239.2.3303A Institut Gustave Roussy
Villejuif, France
1239.2.3303B Institut Gustave Roussy
Villejuif, France
1239.2.3303C Institut Gustave Roussy
Villejuif, France
1239.2.3303D Institut Gustave Roussy
Villejuif, France
1239.2.3303E Institut Gustave Roussy
Villejuif, France
1239.2.3303F Institut Gustave Roussy
Villejuif, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2008
First Posted
December 3, 2008
Study Start
July 1, 2006
Primary Completion
November 1, 2007
Last Updated
December 29, 2017
Record last verified: 2017-12