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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


Phase 2
19 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

4 weeks

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

France: AFFSAPS

Study ID:

1239.2

NCT ID:

NCT00801294

Start Date:

July 2006

Completion Date:

Related Keywords:

  • Colorectal Neoplasms
  • Neoplasms
  • Colorectal Neoplasms

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