Overview
A Phase I Dose Escalation Trial of Afatinib Plus Gemcitabine or Plus Docetaxel
Status:
Completed
Completed
Trial end date:
2015-04-01
2015-04-01
Target enrollment:
0
0
Participant gender:
All
All
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 the combination. To investigate the PK characteristics of docetaxel or gemcitabine and of oral afatinib (BIBW2992) in the tested treatment schedule. To assess antitumor activity.Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Boehringer IngelheimTreatments:
Afatinib
Docetaxel
Gemcitabine
Criteria
Inclusion criteria:1. histologically or cytologically confirmed diagnosis of any advanced or metastatic
relapsed or refractory solid tumor.
Exclusion criteria:
1. Active brain metastases
2. Patients with known pre-existing interstitial lung disease