Know Cancer

forgot password

Extension Study to Establish Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Patients With Previous Clinical Benefit From BIBF 1120

Phase 1
18 Years
Not Enrolling

Thank you

Trial Information

Extension Study to Establish Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Patients With Previous Clinical Benefit From BIBF 1120

Inclusion Criteria:

1. Male or female patients with advanced solid tumours who have completed a previous
study with BIBF 1120. The patients should not have progression of their underlying
tumour disease unless there is evidence for significant clinical benefit (e.g.
symptom improvement) from treatment with BIBF 1120.

2. Age 18 years or older

3. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score <= 2

4. Patients must have given written informed consent (which must be consistent with
ICH-GCP and local legislation)

Exclusion Criteria:

1. Time elapsed from last administration of BIBF 1120 in the previous trial to start of
treatment in the present trial exceeds four weeks

2. Presence of drug related toxicity > grade 2 CTC from previous therapy with BIBF 1120
or presence of drug related continuous toxicity of grade 2 for seven or more
consecutive days which would preclude ongoing chronic therapy with BIBF 1120

3. Active ulcers (gastro-intestinal tract, skin)

4. Major injuries and surgery within the past three weeks with incomplete wound healing

5. Hypersensitivity to BIBF 1120 or the excipients of the trial drug

6. Known secondary malignancy requiring therapy

7. Active infectious disease

8. Significant cardiovascular diseases (i.e. uncontrolled severe hypertension, unstable
angina pectoris, history of myocardial infarction, congestive heart failure > NYHA

9. Gastrointestinal disorders anticipated to interfere with the resorption of the study

10. Brain metastases requiring therapy

11. Absolute neutrophil count less than 1,500/mm3

12. Platelet count less than 100,000/mm3

13. Bilirubin greater than 1.5 mg/dl (> 26 ┬Ámol/L)

14. Aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than
2.5 times the upper limit of normal (if related to liver metastases greater than five
times the upper limit of normal)

15. Serum creatinine greater than 2 mg/dl (> 176 ┬Ámol/L)

16. Concomitant non-oncological diseases which are considered relevant for the evaluation
of the safety of the trial drug

17. Chemo-, radio-, or immunotherapy within the past four weeks prior to treatment with
the trial drug

18. Patients who are sexually active and unwilling to use a medically acceptable method
of contraception

19. Pregnancy or lactation

20. Treatment with other investigational drugs or participation in another clinical trial
within the past four weeks before start of therapy (visit 2) or concomitantly with
this trial (except for a previous study with BIBF 1120)

21. Patients unable to comply with the protocol

22. Active alcohol or drug abuse

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Outcome Measure:

Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE) and changes in safety laboratory parameters

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals



Study ID:




Start Date:

October 2004

Completion Date:

Related Keywords:

  • Neoplasms
  • Neoplasms