Status:
COMPLETED
A Phase I Dose Escalation Trial of Afatinib Plus Gemcitabine or Plus Docetaxel
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Brief Summary
To establish the maximum tolerated dose (MTD) of oral afatinib (BIBW2992) given in combination with gemcitabine or docetaxel in patients with relapsed or refractory tumors. To assess the safety of th...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 1\. histologically or cytologically confirmed diagnosis of any advanced or metastatic relapsed or refractory solid tumor.
- Exclusion criteria:
- Active brain metastases
- Patients with known pre-existing interstitial lung disease
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT01251653
Start Date
November 1 2010
End Date
April 1 2015
Last Update
May 30 2016
Active Locations (3)
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1
1200.93.33002 Boehringer Ingelheim Investigational Site
Dijon, France
2
1200.93.33001 Boehringer Ingelheim Investigational Site
Saint-Herblain, France
3
1200.93.33003 Boehringer Ingelheim Investigational Site
Toulouse, France