Clinical trial · Interventional
Dose Finding Study of BI 6727 (Volasertib) in Patients With Various Solid Cancers
A Phase I Single Dose Escalation Study of Two Dosing Schedules of BI 6727 Administered Intravenously in Asian Patients With Various Solid Cancers With Repeated Administration in Patients With Clinical Benefit
NCT00969553CI-TRIAL-00039746completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 in Asian cancer patients, and to provide safety data in terms of drug-related adverse events.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BI 6727 | Drug | Volasertib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BI 6727
- description
- Schedule A
- interventionNames
- Drug: BI 6727
Primary outcomes (2)
- measure
- Percentage of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib
- timeFrame
- From first administration of study drug up to 3 weeks
- description
- Primary objective for this trial was to identify the MTD of volasertib for 2 dosing schedules. The MTD was defined as the highest volasertib dose studied for which the incidence of DLT was less than 2/6 patients. The MTD was defined on the basis of DLTs observed during the first treatment course only. In this outcome measure the percentage of participants with DLTs in cycle 1 is presented.
- measure
- MTD of Volasertib
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: 1. Patients with histologically or cytologically confirmed diagnosis of advanced solid cancer 2. Age 18 years or older 3. Written informed consent 4. Eastern Cooperative Oncology Group (ECOG) performance score 2 or less Exclusion criteria: 1. Serious illness or concomitant non-oncological disease. 2. Pregnancy or breast feeding 3. Active infectious disease 4. Absolute neutrophil count less than 1,500/cubic millimeter 5. Platelet count less than 100,000/cubic millimeter 6. Bilirubin greater than 1.5 mg/dL (\> 26 µmol/L, SI unit equivalent) 7. Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal 8. Serum creatinine greater than 1.5x ULN.
References
Publications (0)
Data not yet available
No reference posted for this study.