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Dose Escalation Study of Concomitant BIBF 1120 + BIBW 2992 in Patients With Advanced Solid Tumours.

Phase 1
18 Years
Open (Enrolling)

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Trial Information

Dose Escalation Study of Concomitant BIBF 1120 + BIBW 2992 in Patients With Advanced Solid Tumours.

Inclusion Criteria

Inclusion criteria:

1. 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

2. Age 18 years or older.

3. Life expectancy of at least three months.

4. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.

5. Patients previously treated and with asymptomatic brain metastases are eligible

6. Patients must have recovered from recent surgery.

Exclusion criteria:

1. Active infectious disease

2. Recent surgery within the last 4 weeks prior visit 1.

3. Chronic diarrhoea or gastrointestinal tract disease resulting in an inability to take
oral medication

4. History of haemorrhagic or thrombotic events

5. Significant cardiovascular diseases within

6. Current peripheral neuropathy > Common Terminology Criteria for Adverse Events
(CTCAE) grade 1 except due to trauma

7. Untreated or symptomatic brain metastases or leptomeningeal disease.

8. Treatment with an Epidermal growth Factor-receptor (EGFR)- or Heregulin Receptor 2
(HER2) inhibiting drug or antiangiogenic drug.

9. Therapeutic anticoagulation.

10. Female patients of childbearing potential.

11. Known pre-existing interstitial lung disease

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary endpoint of this trial is the assessment of the incidence of Dose Limiting Toxicity (DLT) in the combination BIBW 2992 and BIBF 1120 when administered concomitantly and this incidence will be used to determine the Maximum Tolerated Dose (MTD)

Outcome Time Frame:


Safety Issue:


Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

October 2009

Completion Date:

October 2014

Related Keywords:

  • Neoplasms
  • Neoplasms