Status:
COMPLETED
Phase I Dose Escalation Study of Concomitant BIBF 1120 and BIBW 2992 in Patients With Advanced Solid Tumours.
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objective of this trial is to determine the Maximum Tolerated Dose (MTD) of the combination of BIBW 2992/BIBF 1120 therapy administered concomitantly. The MTD will provide dosing recommend...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with confirmed histological or cytological diagnosis of advanced solid tumours and for whom no proven therapy exists or who are not amenable to established treatments.
- Age 18 years or older.
- Life expectancy of at least three months.
- Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
- Patients previously treated and with asymptomatic brain metastases are eligible
- Patients must have recovered from recent surgery.
- Exclusion criteria:
- Active infectious disease
- Recent surgery within the last 4 weeks prior visit 1.
- Chronic diarrhoea or gastrointestinal tract disease resulting in an inability to take oral medication
- History of haemorrhagic or thrombotic events
- Significant cardiovascular diseases within
- Current peripheral neuropathy \> Common Terminology Criteria for Adverse Events (CTCAE) grade 1 except due to trauma
- Untreated or symptomatic brain metastases or leptomeningeal disease.
- Treatment with an Epidermal growth Factor-receptor (EGFR)- or Heregulin Receptor 2 (HER2) inhibiting drug or antiangiogenic drug.
- Therapeutic anticoagulation.
- Female patients of childbearing potential.
- Known pre-existing interstitial lung disease
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00998296
Start Date
October 1 2009
End Date
July 1 2014
Last Update
August 19 2015
Active Locations (1)
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1
1239.14.3301A Boehringer Ingelheim Investigational Site
Villejuif, France