A Phase I/II Open Label Extension Study of BIBF 1120 Administered Orally Once or Twice Daily to Establish Safety, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumours and Clinical Benefit From Previous Therapy With BIBF 1120
Condition: Neoplasms
Intervention: BIBF 1120
Intervention MeSH terms: Nintedanib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this trial is to evaluate the long-term safety of BIBF 1120 in terms
      of incidence and intensity of Adverse Events and changes in safety laboratory parameters.

      Secondary objectives are the collection of further safety data (vital signs), efficacy data
      and the determination of pharmacokinetic characteristics during long-term therapy with BIBF
      1120.
    

Eligibility criteria:

        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 II)

          9. Gastrointestinal disorders anticipated to interfere with the resorption of the study
             drug

         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 µmol/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 µmol/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