Volasertib Dosing Schedule for Solid Malignancies
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Solution Overview
Problem
Current treatment modalities for advanced or metastatic solid malignancies often result in tumour progression and death, highlighting the need for improved dosage schedules and therapeutic strategies for chemotherapeutic agents like Volasertib.
Innovation Solution
Administering Volasertib at higher frequencies within a 21-day treatment cycle, specifically at 50 to 200 mg doses on days 1 and 8, or days 1 and another day between 5 to 12, to enhance its efficacy in treating advanced or metastatic solid malignancies.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If Volasertib is administered once in a 21-day treatment cycle (standard monotherapy), then the treatment is manageable with acceptable toxicity, but the anti-tumor efficacy is insufficient leading to tumour progression and death
Solution Approach 1:
The treatment cycle is segmented into multiple dosing events (day 1 and day 8) rather than a single dose, allowing the therapeutic effect to be maintained at effective levels while managing toxicity through interval dosing
Solution Approach 2:
The invention implements periodic administration of Volasertib at specific intervals (days 1 and 8 of a 21-day cycle) to maintain therapeutic efficacy while allowing recovery periods, optimizing the balance between anti-tumor effect and toxicity management
2Reliability
If Volasertib dosage is increased to improve anti-tumor activity, then partial responses and stable disease are achieved, but the risk of severe toxicity increases
Solution Approach 1:
The dosage schedule is dynamically optimized by administering higher doses (50-200 mg) at specific intervals rather than continuous low dosing, allowing peak therapeutic concentrations to achieve anti-tumor responses while interspersed rest periods allow toxicity to subside
Solution Approach 2:
The invention changes the temporal parameters of drug administration (frequency and timing) rather than simply increasing dose magnitude, achieving better efficacy-toxicity ratio through optimized dosing intervals on days 1 and 8 of a 21-day cycle
Data Source
AI summary
The present invention relates to the use of Volasertibor a salt thereof or the hydrate thereof for treating patients suffering from solid malignancies including advanced or metastatic solid malignancies comprising a high frequency administration of Volasertib according to a specific dosage schedule.