BI 6727 (Volasertib) in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumour
Condition: Neoplasms
Intervention: BI-6727; BI 6727
Intervention description: Low to high dose (administered every 3 weeks). Depending on the toxicities observed, intermediary dose levels may be added; low to high dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI
      6727 therapy in terms of drug-related adverse events when combined with a platinum therapy
      (cisplatin or carboplatin).

      Secondary objectives are the collection of overall safety and antitumour efficacy data and
      the determination of the pharmacokinetic profile of BI 6727 combination treatment with
      cisplatin and carboplatin.
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients with confirmed diagnosis of advanced, non resectable and / or metastatic
             solid tumours, who have failed conventional treatment, or for whom no therapy of
             proven efficacy exists, or who are not amenable to established forms of treatment

          2. Indication for a treatment with platinum therapy as judged by the investigator

          3. Age 18 years or older

          4. Written informed consent consistent with ICH-GCP and local legislation

          5. ECOG performance score lower or equal 2

          6. Recovery from CTCAE Grade 2 - 4 therapy-related toxicities from previous systemic
             anti-cancer therapies or radiotherapies (except alopecia grade 2)

        Exclusion criteria:

          1. Serious illness or concomitant non-oncological disease considered by the investigator
             to be incompatible with the protocol

          2. Pregnancy or breastfeeding

          3. Active infectious disease or known chronic Hepatitis B/Hepatitis C infection and HIV
             I/II

          4. Clinical evidence of symptomatic progressive brain or leptomeningeal disease during
             the past 6 months

          5. Second malignancy currently requiring another anti-cancer therapy

          6. ANC less than 1500 / mm3

          7. Platelet count less than 100 000 / mm3

          8. Bilirubin greater than 1.5 mg / dl (> 26 micromol / L, SI unit equivalent) (except
             Gilbert's syndrome)

          9. 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)

         10. Serum creatinine greater than 1.5 mg / dl (> 132 micromol / L, SI unit equivalent) or
             creatinine clearance <70ml/min (as calculated according to Cockcroft-Gault formula for
             GFR estimate)

         11. Known history of relevant QT-prolongation, e.g. long QT-syndrome

         12. Pre-existing clinically relevant hearing loss

         13. Women and men who are sexually active and unwilling to use a medically acceptable
             method of contraception

         14. Treatment with other investigational drugs or participation in another clinical
             interventional trial within the past four weeks before start of therapy or
             concomitantly with this trial

         15. Systemic anti-cancer therapy or radiotherapy within the past four weeks before start
             of therapy or concomitantly with this trial. This restriction does not apply to
             steroids and bisphosphonates.

         16. Patients unable to comply with the protocol

         17. Active alcohol or drug abuse