A Phase I Dose Escalation Trial of BI 6727 in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumors
Inclusion 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