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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
This study has been completed.
First Received: December 2, 2008   Last Updated: April 24, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00801294
  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 II

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: BIBW 2992 BIBF 1120
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase II Trial of Weekly Alternating Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Advanced Colorectal Cancer

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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: 4 weeks ]

Secondary Outcome Measures:
  • Progression free survival Overall survival The incidence and intensity of AE changes in safety laboratory parameters Pharmacokinetic analysis

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

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1239.2, EudraCT 2006-000893-56
Study First Received: December 2, 2008
Last Updated: April 24, 2009
ClinicalTrials.gov Identifier: NCT00801294     History of Changes
Health Authority: France: AFFSAPS;   United States: Food and Drug Administration

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

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

ClinicalTrials.gov processed this record on May 07, 2009