At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 5 enrolled
Drug / intervention
Azacitidine +1 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 Trial of Intravenous Volasertib in Combination With Subcutaneous Azacitidine in Japanese Patients With Higher-risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
In Brief
A Phase 1 clinical trial evaluating Azacitidine and Volasertib for Myelodysplastic Syndromes and Leukemia, Myelomonocytic, Chronic. Completed, enrolled 5 participants across 4 sites.
Detailed Summary
To identify the maximum tolerated dose or recommended dose for further development of volasertib in combination with azacitidine in Japanese patients with myelodysplastic syndromes or chronic myelomonocytic leukemia, and evaluate the safety and tolerability, pharmacokinetics and the preliminary efficacy of this combination.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 2014
Enrollment StartAug 2014
Primary CompletionJan 2015
Study CompletionSep 2015
TodayJul 2026
First PostedJul 28, 2014
Enrollment StartAug 1, 2014
Primary CompletionJan 1, 2015
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 11.9 years ago
Interventions
Azacitidinedrug
Azacitidine (subcutaneous)
Volasertibdrug
Volasertib escalating doses (intravenous)