Open Dose Escalating Trial to Determine the Maximum Tolerated Dose in Paediatric Patients With Advanced Cancers for Whom no Therapy is Known

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-22

Study Completion Date

2017-01-27

Brief Summary

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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

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Detailed Description

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Conditions

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Leukemia Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All patients

Volasertib will be administered as intravenous infusion

Group Type EXPERIMENTAL

volasertib

Intervention Type DRUG

intravenous administration on day 1of a treatment course

Interventions

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volasertib

intravenous administration on day 1of a treatment course

Intervention Type DRUG

Eligibility Criteria

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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 Central Nervous System 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

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No