Combination of BI6727 (Volasertib) and BIBF1120 in Solid Tumors

Launched by BOEHRINGER INGELHEIM · Nov 26, 2009

Keywords

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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