CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 22 enrolled
Drug / intervention
volasertibdrug
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.

Search/NCT01971476
NCT01971476Phase 1Completed
CompareCT.gov

Open, Non-controlled, Dose Escalating Phase I Trial to Evaluate the Pharmacokinetics, Pharmacodynamics, Tolerability and Toxicity of Volasertib in Paediatric Patients From 2 Years to Less Than 18 Years of Age With Acute Leukaemia or Advanced Solid Tumour, for Whom no Effective Treatment is Known

Boehringer Ingelheim·interventional·Posted Oct 29, 2013·Updated Jul 30, 2018

In Brief

A Phase 1 clinical trial evaluating volasertib for Leukemia and Neoplasms. Completed, enrolled 22 participants across 5 sites in 5 countries.

Detailed Summary

The present trial will be performed according to an open design to determine the maximum tolerable dose (MTD) by evaluation of dose-limiting toxicity (DLT) of volasertib in paediatric leukaemia and solid tumours in the age group 2 to less than 12 and 12 to less than 18 years. A further objective is to collect data on safety, tolerability, toxicity, efficacy (preliminary activity), pharmacokinetics and pharmacodynamics of volasertib in paediatric cancer patients

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Neoplasms
CountriesBelgium, Czechia, France, Germany, Italy
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 29, 2013
Enrollment StartOct 22, 2013
Primary CompletionJun 1, 2015
Study CompletionJan 27, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.7 years ago

Interventions

volasertibdrug

intravenous administration on day 1of a treatment course