Combination of BI6727 (Volasertib) and BIBF1120 in Solid Tumors
Condition: Neoplasms
Intervention: BI 6727; BIBF 1120
Intervention description: intravenous each 21 days; oral continuously
Intervention MeSH terms: Nintedanib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the current study is to investigate the Maximum Tolerated Dose (MTD)
      in terms of safety and tolerability of BI 6727 in combination with fixed dose BIBF 1120, in
      patients with advanced or metastatic solid tumours.
    

Eligibility 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
             bisphosphonates

          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