An Open-label Phase I Study of Once Daily Oral Treatment With BIBW 2992 in Combination With Weekly Vinorelbine Intravenous Injection in Japanese Patients With Advanced Solid Tumours
Phase 1
20 Years
74 Years
20 Years
74 Years
Not Enrolling
Both
Neoplasms
Both
Neoplasms
Trial Information
An Open-label Phase I Study of Once Daily Oral Treatment With BIBW 2992 in Combination With Weekly Vinorelbine Intravenous Injection in Japanese Patients With Advanced Solid Tumours
Inclusion Criteria
Inclusion criteria:
- Histologically confirmed diagnosis of malignancy that is advanced and for which
standard therapies do not exist or are no longer effective.
- Life expectancy at least 12 weeks
- Eastern Cooperative Oncology Group Performance Status 0 or 1
- Adequate hepatic, renal, haematologic and other organ function
- Written informed consent
Exclusion criteria:
- Chemotherapy, immunotherapy, surgery and radiotherapy within the past 4 weeks
- Prior treatment with BIBW 2992 and or vinorelbine
- Clinically significant active infectious disease
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence and intensity of adverse events according to Common Toxicity Criteria for Adverse Events 3.0
Outcome Time Frame:
Unspecified
Safety Issue:
No
Principal Investigator
Boehringer Ingelheim
Investigator Role:
Study Chair
Investigator Affiliation:
Boehringer Ingelheim Pharmaceuticals
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
1200.84
NCT ID:
NCT01214616
Start Date:
October 2010
Completion Date:
May 2013
Related Keywords:
- Neoplasms
- Neoplasms
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