Conditions: Neoplasms
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 61
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: patient to receive 3-weekly infusion escalating dose of BI 6727 combined to cisplatin arm 2: patient to receive 3-weekly infusion escalating dose of BI 6727 combined to carboplatin

Interventions: intervention 1: BI-6727 intervention 2: BI 6727
Intervention descriptions: intervention 1: Low to high dose (administered every 3 weeks). Depending on the toxicities observed, intermediary dose levels may be added intervention 2: low to high dose

Protocol document: