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Dose Escalation Trial of BI 6727 in Combination With BIBF 1120

Phase 1
18 Years
Not Enrolling

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Trial Information

Dose Escalation Trial of BI 6727 in Combination With BIBF 1120

Inclusion Criteria

Inclusion criteria:

1. Patients with confirmed diagnosis of advanced, non resectable and/or metastatic solid
tumours, who have failed conventional treatment, and for whom no therapy of proven
efficacy exists, or who are not amenable to established forms of treatment

2. Age > or = 18 years

3. European Cooperative Oncology Group performance status < or = 2

4. Written informed consent in accordance with International Conference on Harmonization
-Good Clinical Practice (ICH-GCP) and local legislation

5. Recovery from Common Terminology Criteria for Adverse Events grade 2-4
therapy-related toxicities from previous systemic anti-cancer therapies or
radiotherapy (except alopecia)

Exclusion criteria:

1. Serious illness or concomitant non-oncological disease considered by the investigator
to be incompatible with the trial

2. Known hypersensitivity to the trial drugs or their excipients

3. Treatment with any other investigational drug or participation in any other
interventional trial within 28 days before first administration of trial drug (BIBF
1120) or concomitantly with this trial

4. Systemic anti-cancer therapy or radiotherapy within 28 days before start of therapy
or concomitantly with this trial. The restriction does not apply to steroids and

5. Active infectious disease infection or HIV I/II

6. Other malignancy currently requiring another anti-cancer therapy

7. Clinical evidence of symptomatic progressive brain or leptomeningeal disease during
the past 6 months

8. Known inherited predisposition to bleeding or thrombosis

9. Radiographic evidence of cavitary or necrotic tumours

10. History of clinically significant haemoptysis within the past 3 months

11. Centrally located tumours with radiographic evidence (Computed Tomography or Magnetic
Resonance Imaging) of local invasion of major blood vessels

12. Absolute Neutrophil Count (ANC) less than 1.5 x 1000000000/L

13. Platelets Count (PLT) less than 100 x 1000000000/L

14. Total bilirubin > upper limit of normal (ULN)

15. Alaninaminotransferase (ALT) and/or Aspartateaminotransferase (AST) >= 1.5 x ULN (in
case of liver metastases: ALT and AST >= 2.5 x ULN)

16. Serum creatinine > 1.5 mg/dl

17. Major injuries and/or surgery or bone fracture within 28 days before first
administration of trial drug (BIBF 1120), or planned surgical procedures during the
trial period

18. Known history of clinically relevant QT prolongation (e.g. long QT syndrome)

19. History of severe haemorrhagic or thromboembolic event in the past 6 months
(excluding central venous catheter thrombosis and peripheral deep vein thrombosis)

20. Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed
for maintenance of an indwelling intravenous device) or antiplatelet therapy (except
for chronic low-dose therapy with acetylsalicylic acid < or = 325mg per day)

21. Active alcohol or drug abuse

22. Women and men who are sexually active and unwilling to use a medically acceptable
method of contraception during the trial

23. Pregnancy or breast-feeding

24. Patients unable to comply with the protocol

25. Uncontrolled hypertension

Type of Study:


Study Design:

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

Outcome Measure:

Maximum Tolerated Dose of BI 6727 in combination with 200 mg BIBF 1120 given bis in die

Outcome Time Frame:

12 Months (ie during the enrollment period)

Safety Issue:


Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals


Italy: National Institute of Health

Study ID:




Start Date:

December 2009

Completion Date:

February 2013

Related Keywords:

  • Neoplasms
  • Neoplasms