Overview

This trial is active, not recruiting.

Conditions leukemia, neoplasms
Treatment volasertib
Phase phase 1
Sponsor Boehringer Ingelheim
Start date October 2013
End date June 2015
Trial size 22 participants
Trial identifier NCT01971476, 1230.27, 2013-001291-38

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Volasertib will be administered as intravenous infusion
volasertib
intravenous administration on day 1of a treatment course

Primary Outcomes

Measure
number of patients with dose limiting toxicity
time frame: 14 days

Secondary Outcomes

Measure
number of patients with hepatic injury as defined as protocol-specified adverse events of special interest
time frame: up to 6 months
number of patients with clinically relevant lab value changes of calcium (hyper and/or hypocalcaemia) as judged by the investigator and reported as adverse events (Common Terminology Criteria for Adverse Event grade 3 or higher)
time frame: up to 6 months
number of patients with changes in cardiac activity (prolonged QTc interval) reported as clinically relevant observations ( Adverse Events)
time frame: up to 6 months
number of patients with complete remission (CR)
time frame: up to 6 months
progression free survival
time frame: up to one year
overall survival
time frame: up to one year
number of patients with complete remission with incomplete blood count (CRi)
time frame: up to 6 months
number of patients with partial response/remission (PR)
time frame: up to 6 months

Eligibility Criteria

Male or female participants from 2 years up to 17 years old.

Inclusion criteria: - paediatric patients with leukaemia or advanced solid tumours including lymphomas (age 2 - less than 18 years) for whom no further treatment is known - Lansky score > 60 for children 2 to less than 12 years - Karnofsky score > 60 for children aged 12 or older - life expectancy of at least 6 weeks as judged by the investigator - parents or legal guardians have given written informed consent and informed assent suitable for the respective age group obtained Exclusion criteria: - patient eligible for other anti-leukaemic therapy with curative intent or effective therapy known for solid tumour therapy - presence of cardiac disease (LVEF by echocardiography less than 25 %) - symptomatic CNS involvement of the malignant disease - primary CNS tumour - inadequate lab parameters - inadequate venous access - QTc prolongation - pregnancy, breastfeeding - other diseases or CTs that might interfere with evaluation of safety

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.