At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 15 enrolled
Drug / intervention
Volasertib, low dose, d1q3w +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Phase I Study of Once Every Three Weeks Intravenous Treatment With BI 6727 in Japanese Patients With Advanced Solid Tumours
In Brief
A Phase 1 clinical trial evaluating Volasertib, low dose, d1q3w, Volasertib, middle dose, d1q3w, and 1 other intervention for Neoplasms. Completed, enrolled 15 participants across 1 site.
Detailed Summary
This open-label phase I dose escalation trial, 1230.15, is the first trial with Volasertib in Japanese advanced cancer patients. The trial will investigate the maximum tolerated dose (MTD), safety, tolerability, and preliminary efficacy of this specific polo-like kinase 1 (Plk1) inhibitor in advanced cancer patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2011
First PostedMay 2011
Primary CompletionAug 2012
Study CompletionMay 2014
TodayJul 2026
First PostedMay 5, 2011
Enrollment StartApr 25, 2011
Primary CompletionAug 27, 2012
Study CompletionMay 15, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.2 years ago
Interventions
Volasertib, low dose, d1q3wdrug
Patient to receive low dose of Volasertib IV
Volasertib, middle dose, d1q3wdrug
Patient to receive middle dose of Volasertib IV
Volasertib, high dose, d1q3wdrug
Patient to receive high dose of Volasertib IV