An Open Label Phase I Dose Escalation Trial of Intravenous BI 6727 in Combination With Oral BIBW 2992 in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit
Inclusion Criteria
Inclusion criteria:
- Patients with histologically or cytologically confirmed diagnosis of advanced, non
resectable and/or metastatic, relapsed or refractory solid tumours not amenable to
standard therapy and for whom no therapy of proven efficacy exists
- Eastern Cooperative Oncology Group performance score 0 - 2
- Recovery from clinically significant toxicities from previous systemic anti-cancer
therapies or radiotherapy
Exclusion criteria:
- Serious illness, concomitant non-oncological disease or mental problem considered by
the investigator to be incompatible with participation to the trial
- Known hypersensitivity to the trial drugs or their excipients
- Treatment with any other investigational drug or active participation in any other
interventional trial within 28 days before first administration of trial drug(s) or
concomitantly with this trial
- Major surgery or radiotherapy within 28 days before start of therapy or concomitantly
with this trial
- Systemic anti-cancer therapy within 28 days before start of therapy or concomitantly
with this trial
- Requirements for treatment with any of the prohibited concomitant medications
- Active infectious disease or known HIV I/II infection
- Gastrointestinal disorders that may interfere with the absorption of the study drug
or chronic diarrhoea
- Active brain metastases
- History or presence of cardiovascular abnormalities deemed clinically relevant by the
investigator
- Cardial left ventricular function with resting ejection fraction < 50%
- Inadequate hepatic, renal and haematologic organ function
- QT prolongation deemed clinically relevant by the investigator
- Active alcohol or drug abuse
- Women of childbearing potential and men who are able to father a child unwilling to
use a medically acceptable method of contraception during the trial and 28 days
thereafter
- Pregnancy or breast-feeding
- Patients unable to comply with the protocol
- Patients with known pre-existing interstitial lung disease