Status:
COMPLETED
BIBW 2992 (Afatinib) and Vinorelbine in Japanese Patients With Advanced Solid Tumours
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Neoplasms
Eligibility:
All Genders
20-74 years
Phase:
PHASE1
Brief Summary
* To identify the Maximum Tolerated Dose (MTD) of afatinib in combination with vinorelbine i.v. by assessment of Dose Limiting Toxicities (DLT); * To assess safety and anti-tumour efficacy and determi...
Eligibility Criteria
Inclusion
- 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 afatinib and or vinorelbine
- Clinically significant active infectious disease
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01214616
Start Date
October 1 2010
End Date
May 1 2013
Last Update
February 7 2025
Active Locations (4)
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1
1200.84.003 Boehringer Ingelheim Investigational Site
Chuo-ku, Osaka, Osaka, Japan
2
1200.84.004 Boehringer Ingelheim Investigational Site
Kashiwa, Chiba, Japan
3
1200.84.001 Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan
4
1200.84.002 Boehringer Ingelheim Investigational Site
Sakyo-ku, Kyoto, Kyoto, Japan