Status:
COMPLETED
A Phase II Trial of Weekly Alternating Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Advanced Colorectal Cancer
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
19+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00801294
Start Date
July 1 2006
Last Update
December 29 2017
Active Locations (24)
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1
1239.2.3305A clinique Saint Jean
Lyon, France
2
1239.2.3305B Cabinet Médical
Lyon, France
3
1239.2.3301A Hôpital Saint Antoine
Paris, France
4
1239.2.3301B Hôpital Saint Antoine
Paris, France