A Phase II Trial of Weekly Alternating Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Advanced Colorectal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Trial of Weekly Alternating Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Advanced Colorectal Cancer

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Drug: BIBF 1120 and BIBW 2992


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: BIBF 1120 and BIBW 2992|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |