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

Phase 2

Completed

• Conditions: Colorectal Neoplasms

• Registration Number: NCT00801294
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-01
• Primary Completion: 2007-11-01
• Study First Submitted: 2008-12-02
• Study First Submitted QC: 2008-12-02
• Study First Posted: 2008-12-03
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-28
• Last Update Posted: 2017-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Age over 18 years.
2. Signed informed consent.
3. Histologically proven colorectal adenocarcinoma
4. History or presence of metastatic colorectal cancer (stage IV)
5. Measurable (>1 cm) or evaluable tumour deposit (according to RECIST criteria)
6. Documented progression or unacceptable toxicity on the last therapy
7. Progression on oxaliplatin-based chemotherapy or unacceptable residual neurotoxicity on oxaliplatin
8. Progression on irinotecan-based chemotherapy or unacceptable toxicity on irinotecan
9. If patients have been previously exposed to Cetuximab or other EGFR inhibitor, they must have shown progression or unacceptable toxicity
10. If patients have been previously exposed to Bevacizumab or other VEGF inhibitor, they must have shown progression or unacceptable toxicity
11. Life expectancy of at least 12 weeks.
12. WHO (ECOG) performance status <= 2, <= 1 if age > 75 years.
13. Adequate hepatic function
14. Adequate renal function

Exclusion Criteria

1. Prior treatment with small molecule EGFR, HER2 or VEGFR tyrosine kinase inhibitors
2. Treatment with standard chemotherapy or cetuximab within the last 14 days
3. Treatment with bevacizumab within the last 28 days
4. 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.
5. Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality
6. Significant cardiovascular diseases
7. History of haemorrhagic or thrombotic event in the past 12 months. Known inherited predisposition to bleeds or to thrombosis.
8. Patient with history or clinical or radiological evidence of CNS disease or brain metastases.
9. Pregnancy or breast-feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Progression-free survival (based on the RECIST criteria)	66 Weeks
Overall survival	66 Weeks
Effectiveness of dose reduction guidelines in managing adverse events	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

Trial Locations

Locations (24)

1239.2.3305A clinique Saint Jean; 🇫🇷 Lyon, France

1239.2.3305B Cabinet Médical; 🇫🇷 Lyon, France

1239.2.3301A Hôpital Saint Antoine; 🇫🇷 Paris Cedex 12, 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

1239.2.3301F 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

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