A Phase I Dose Escalation Trial of Afatinib Plus Gemcitabine or Plus Docetaxel

Boehringer Ingelheim

Status: Completed

Conditions: Neoplasms

Treatments: Drug: docetaxel; Drug: Afatinib; Drug: gemcitabine

Study type: Observational

Funder types: Industry

Identifiers

NCT01251653

1200.93

2010-020560-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

94 participants in 2 patient groups

Afatinib and docetaxel

Treatment:

Drug: Afatinib

Drug: docetaxel

Drug: Afatinib

Afatinib and gemcitabine

Treatment:

Drug: gemcitabine

Drug: Afatinib

Drug: Afatinib