Phase 1
N=59
Dose Finding Study of BI 6727 (Volasertib) in Patients With Various Solid Cancers
Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00969553 ↗Enrolled (actual)
59
Serious AEs
37.3%
Results posted
Jul 2019
Primary outcome: Primary: Percentage of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib — 0.0; 0.0; 16.7; 23.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 6727 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib |
0.0; 0.0; 16.7; 23.5; 100; 0.0 | — |
| PRIMARY MTD of Volasertib |
300; 150 | — |
| SECONDARY Percentage of Participants With Incidence and Intensity of Drug-related AEs According to CTCAE v.3.0 |
0.0; 0.0; 0.0; 5.9; 0.0; 0.0 | — |
| SECONDARY Change From Baseline to Last Value on Treatment in Platelets |
-30; -62; -5; -10; -55; -18 | — |
| SECONDARY Change From Baseline to Last Value on Treatment in Neutrophils |
0.9; -1.4; -1.3; -0.8; -0.7; 1.3 | — |
| SECONDARY Patient Performance |
0; 0; 0; 6; 0; 0 | — |
| SECONDARY Vital Signs (Blood Pressure) |
-19.0; 4.7; 0.0; -1.0; -12.3; 6.0 | — |
| SECONDARY Vital Signs (Pulse Rate) |
18.3; 9.7; 16.5; 10.4; 2.7; 13.5 | — |
| SECONDARY ECG |
21.0; 13.9; 5.2; 6.3 | — |
| SECONDARY Objective Response |
100; 100; 100; 100; 67; 100 | — |
| SECONDARY Progression-free Survival |
83.0; 62.0; 48.0; 49.0; 274.0; 42.5 | — |
| SECONDARY Response Duration |
— | — |
| SECONDARY Disease Control |
33; 33; 67; 59; 33; 75 | — |
| SECONDARY Sum of the Largest Diameters of Target Lesions |
— | — |
| SECONDARY Pharmacokinetics (PK) AUC0-∞ of Volasertib |
2140; 3280; 6140; 6260; 9790 | — |
| SECONDARY Pharmacokinetics (PK) AUC0-168 of Volasertib |
590; 1380; 1890; 3320; 847; 1870 | — |
| SECONDARY Pharmacokinetics (PK) Cmax of Volasertib |
186; 540; 540; 489; 675; 106 | — |
Summary
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.
Eligibility Criteria
Inclusion criteria
- Patients with histologically or cytologically confirmed diagnosis of advanced solid cancer
- Age 18 years or older
- Written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance score 2 or less
Exclusion criteria
- Serious illness or concomitant non-oncological disease.
- Pregnancy or breast feeding
- Active infectious disease
- Absolute neutrophil count less than 1, 500/cubic millimeter
- Platelet count less than 100,000/cubic millimeter
- Bilirubin greater than 1.5 mg/dL (> 26 µmol/L, SI unit equivalent)
- Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal
- Serum creatinine greater than 1.5x ULN.
Data sourced from ClinicalTrials.gov (NCT00969553). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.