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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00801294
First received: December 2, 2008
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Colorectal Neoplasms
Drug: BIBF 1120 and BIBW 2992
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Phase II Trial of Weekly Alternating Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Advanced Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival (based on the RECIST criteria) [ Time Frame: 66 Weeks ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 66 Weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Changes in safety laboratory parameters [ Time Frame: 66 Weeks ] [ Designated as safety issue: No ]
  • Effectiveness of dose reduction guidelines in managing adverse events [ Time Frame: 66 Weeks ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: July 2006
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00801294

Locations
France
1239.2.3305B Cabinet Médical
Lyon, France
1239.2.3305A clinique Saint Jean
Lyon, France
1239.2.3301A Hôpital Saint Antoine
Paris Cedex 12, France
1239.2.3301K 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
1239.2.3301I Hôpital Saint Antoine
Paris Cedex 12, France
1239.2.3301E Hôpital Saint Antoine
Paris Cedex 12, France
1239.2.3301J 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
1239.2.3301D Hôpital Saint Antoine
Paris Cedex 12, France
1239.2.3301F Hôpital Saint Antoine
Paris Cedex 12, France
1239.2.3302A Hôpital Tenon
Paris Cedex 20, France
1239.2.3302B Hôpital Tenon
Paris Cedex 20, France
1239.2.3304A Hôpital Robert Debré
Reims Cedex, France
1239.2.3304C Hôpital Robert Debré
Reims Cedex, France
1239.2.3304B Hôpital Robert Debré
Reims Cedex, France
1239.2.3303D Institut Gustave Roussy
Villejuif Cedex, France
1239.2.3303F Institut Gustave Roussy
Villejuif Cedex, France
1239.2.3303B Institut Gustave Roussy
Villejuif Cedex, France
1239.2.3303C Institut Gustave Roussy
Villejuif Cedex, France
1239.2.3303A Institut Gustave Roussy
Villejuif Cedex, France
1239.2.3303E Institut Gustave Roussy
Villejuif Cedex, France
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00801294     History of Changes
Other Study ID Numbers: 1239.2, EudraCT 2006-000893-56
Study First Received: December 2, 2008
Last Updated: October 30, 2013
Health Authority: France: AFFSAPS
United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 23, 2014