BI 6727 Administered Intravenously Every 3 Weeks in Patients With Solid Tumours

An Open Phase I Single Dose Escalation Study of BI 6727 Administered Intravenously in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit

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. Secondary objectives are the collection of overall safety and antitumour efficacy data and the determination of the pharmacokinetic profile of BI 6727.

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. Age 18 years or older

3. Written informed consent consistent with ICH-GCP and local legislation

4. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score ¿ 2

5. Recovery from CTCAE Grade 2 - 4 therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies (except alopecia)

   The 18 additional patients recruited at the MTD must also meet the following criterion:

6. Measurable tumour deposits (RECIST) by one or more techniques (CT, MRI)

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
4. Clinical evidence of active brain or leptomeningeal disease during the past 12 months
5. Second malignancy currently requiring active therapy
6. Absolute neutrophil count less than 1500 / mm3
7. Platelet count less than 100 000 / mm3
8. Bilirubin greater than 1.5 mg / dl (> 26 ¿mol / L, SI unit equivalent)
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 ¿mol / L, SI unit equivalent)
11. Known history of relevant QT-prolongation, e.g. long QT-syndrome
12. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
13. Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
14. Chemo-, radio or immunotherapy within the past four weeks before start of therapy or concomitantly with this trial. This restriction does not apply to steroids and bisphosphonates.
15. Patients unable to comply with the protocol
16. Active alcohol or drug abuse