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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-01

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.

Detailed Description

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Conditions

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Colorectal Neoplasms

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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BIBF 1120 and BIBW 2992

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

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EudraCT 2006-000893-56

Identifier Type: -

Identifier Source: secondary_id

1239.2

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Interventions

BIBF 1120 and BIBW 2992

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Boehringer Ingelheim

Responsible Party

Principal Investigators

Boehringer Ingelheim

Locations

1239.2.3305A clinique Saint Jean

1239.2.3305B Cabinet Médical

1239.2.3301A Hôpital Saint Antoine

1239.2.3301B Hôpital Saint Antoine

1239.2.3301C Hôpital Saint Antoine

1239.2.3301D Hôpital Saint Antoine

1239.2.3301E Hôpital Saint Antoine

1239.2.3301F Hôpital Saint Antoine

1239.2.3301G Hôpital Saint Antoine

1239.2.3301H Hôpital Saint Antoine

1239.2.3301I Hôpital Saint Antoine

1239.2.3301J Hôpital Saint Antoine

1239.2.3301K Hôpital Saint Antoine

1239.2.3302A Hôpital Tenon

1239.2.3302B Hôpital Tenon

1239.2.3304A Hôpital Robert Debré

1239.2.3304B Hôpital Robert Debré

1239.2.3304C Hôpital Robert Debré

1239.2.3303A Institut Gustave Roussy

1239.2.3303B Institut Gustave Roussy

1239.2.3303C Institut Gustave Roussy

1239.2.3303D Institut Gustave Roussy

1239.2.3303E Institut Gustave Roussy

1239.2.3303F Institut Gustave Roussy

Countries

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Other Identifiers

EudraCT 2006-000893-56

1239.2