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

December 28, 2017 updated by: Boehringer Ingelheim
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France
        • 1239.2.3305A clinique Saint Jean
      • Lyon, France
        • 1239.2.3305B Cabinet Médical
      • Paris Cedex 12, 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
        • 1239.2.3301I Hôpital Saint Antoine
      • Paris Cedex 12, France
        • 1239.2.3301J Hôpital Saint Antoine
      • Paris Cedex 12, France
        • 1239.2.3301K Hôpital Saint Antoine
      • Paris Cedex 20, France
        • 1239.2.3302A Hôpital Tenon
      • Paris Cedex 20, France
        • 1239.2.3302B Hôpital Tenon
      • Reims Cedex, France
        • 1239.2.3304A Hôpital Robert Debré
      • Reims Cedex, France
        • 1239.2.3304B Hôpital Robert Debré
      • Reims Cedex, France
        • 1239.2.3304C Hôpital Robert Debré
      • Villejuif Cedex, France
        • 1239.2.3303A Institut Gustave Roussy
      • Villejuif Cedex, France
        • 1239.2.3303B Institut Gustave Roussy
      • Villejuif Cedex, France
        • 1239.2.3303C Institut Gustave Roussy
      • Villejuif Cedex, France
        • 1239.2.3303D Institut Gustave Roussy
      • Villejuif Cedex, France
        • 1239.2.3303E Institut Gustave Roussy
      • Villejuif Cedex, France
        • 1239.2.3303F Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Interventional Model: PARALLEL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The RECIST criterion will be used to assess: objective response rate (PR + CR), and disease progression within the first 16 weeks
Time Frame: every 4 weeks
every 4 weeks
PFS
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (based on the RECIST criteria)
Time Frame: 66 Weeks
66 Weeks
Overall survival
Time Frame: 66 Weeks
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)
Time Frame: 66 Weeks
66 Weeks
Changes in safety laboratory parameters
Time Frame: 66 Weeks
66 Weeks
Effectiveness of dose reduction guidelines in managing adverse events
Time Frame: 66 Weeks
66 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2006

Primary Completion (ACTUAL)

November 1, 2007

Study Registration Dates

First Submitted

December 2, 2008

First Submitted That Met QC Criteria

December 2, 2008

First Posted (ESTIMATE)

December 3, 2008

Study Record Updates

Last Update Posted (ACTUAL)

December 29, 2017

Last Update Submitted That Met QC Criteria

December 28, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1239.2
  • EudraCT 2006-000893-56

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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