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An Open Phase I Single Dose Escalation Study of BI 2536 BS Administered Intravenously in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit
The primary objective of this study was to determine the maximum tolerated dose (MTD) of BI 2536 BS in patients with advanced solid tumours. Secondary objectives were the evaluation of safety, efficacy, and pharmacokinetics of BI 2536 BS
Details
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 63 |
| Start date | 2004-08 |
Conditions
- Neoplasms
Interventions
- BI 2536 BS, intravenous
Primary outcomes
- Maximum tolerated dose (MTD) for a single dose of BI 2536 BS — Up to 16 weeks
- MTD for single doses of BI 2536 BS on 3 consecutive days — Up to 16 weeks