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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

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
BIBF 1120 and BIBW 2992
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Progression-free survival (based on the RECIST criteria)
Overall survival
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)
Changes in safety laboratory parameters
Effectiveness of dose reduction guidelines in managing adverse events

Full Information

First Posted
December 2, 2008
Last Updated
December 28, 2017
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00801294
Brief Title
A Phase II Trial of Weekly Alternating Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Advanced Colorectal Cancer
Official Title
A Phase II Trial of Weekly Alternating Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Advanced Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2006 (Actual)
Primary Completion Date
November 1, 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
BIBF 1120 and BIBW 2992
Primary Outcome Measure Information:
Title
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
Title
PFS
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Progression-free survival (based on the RECIST criteria)
Time Frame
66 Weeks
Title
Overall survival
Time Frame
66 Weeks
Title
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
Title
Changes in safety laboratory parameters
Time Frame
66 Weeks
Title
Effectiveness of dose reduction guidelines in managing adverse events
Time Frame
66 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1239.2.3305A clinique Saint Jean
City
Lyon
Country
France
Facility Name
1239.2.3305B Cabinet Médical
City
Lyon
Country
France
Facility Name
1239.2.3301A Hôpital Saint Antoine
City
Paris Cedex 12
Country
France
Facility Name
1239.2.3301B Hôpital Saint Antoine
City
Paris Cedex 12
Country
France
Facility Name
1239.2.3301C Hôpital Saint Antoine
City
Paris Cedex 12
Country
France
Facility Name
1239.2.3301D Hôpital Saint Antoine
City
Paris Cedex 12
Country
France
Facility Name
1239.2.3301E Hôpital Saint Antoine
City
Paris Cedex 12
Country
France
Facility Name
1239.2.3301F Hôpital Saint Antoine
City
Paris Cedex 12
Country
France
Facility Name
1239.2.3301G Hôpital Saint Antoine
City
Paris Cedex 12
Country
France
Facility Name
1239.2.3301H Hôpital Saint Antoine
City
Paris Cedex 12
Country
France
Facility Name
1239.2.3301I Hôpital Saint Antoine
City
Paris Cedex 12
Country
France
Facility Name
1239.2.3301J Hôpital Saint Antoine
City
Paris Cedex 12
Country
France
Facility Name
1239.2.3301K Hôpital Saint Antoine
City
Paris Cedex 12
Country
France
Facility Name
1239.2.3302A Hôpital Tenon
City
Paris Cedex 20
Country
France
Facility Name
1239.2.3302B Hôpital Tenon
City
Paris Cedex 20
Country
France
Facility Name
1239.2.3304A Hôpital Robert Debré
City
Reims Cedex
Country
France
Facility Name
1239.2.3304B Hôpital Robert Debré
City
Reims Cedex
Country
France
Facility Name
1239.2.3304C Hôpital Robert Debré
City
Reims Cedex
Country
France
Facility Name
1239.2.3303A Institut Gustave Roussy
City
Villejuif Cedex
Country
France
Facility Name
1239.2.3303B Institut Gustave Roussy
City
Villejuif Cedex
Country
France
Facility Name
1239.2.3303C Institut Gustave Roussy
City
Villejuif Cedex
Country
France
Facility Name
1239.2.3303D Institut Gustave Roussy
City
Villejuif Cedex
Country
France
Facility Name
1239.2.3303E Institut Gustave Roussy
City
Villejuif Cedex
Country
France
Facility Name
1239.2.3303F Institut Gustave Roussy
City
Villejuif Cedex
Country
France

12. IPD Sharing Statement

Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/21737652
Description
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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

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