Adult patients who suffer from advanced liposarcoma will be included in this study. Liposarcoma is a malignant tumour which originates in fatty tissue. Advanced means that the tumour has already spread to the surrounding tissue and/or has formed metastases. The goal of the study is to find out whether combined treatment with the two substances HDM201 and LEE011 (which have not yet been approved for the treatment of liposarcoma) are safe and effective for the patients and, if so, in which dose.
The study is divided into two sections:
In section one, the dose of both trial products will be increased gradually until a maximum dose at which no unacceptable side-effects appear when administered is determined for each product. About 42 patients will take part in this section of the study.
In section two, the patients will receive HDM201 and LEE011, each at the dose and according to the dosing regimen which was determined to be optimal in the first section of the study. Approximately 44 patients will take part in this section of the study.
The physician will inform the patients whether they can take part in the first or second section before the study begins.
Before the study, the investigator conducts an entry examination in which the patients are examined extensively and their suitability for taking part in the study is assessed.
If this preliminary examination indicates that the patient can take part in the clinical study, the investigator will inform him/her how many capsules of HDM201 and LEE011 he/she will have to take according to which regimen, and the treatment phase will begin.
The patients will be asked to visit the study site regularly for the first six months of the study. During this period, the frequency of these visits may fluctuate between several times a week to twice every three or four weeks. After six months, the patients will only visit the study site once a month.
Extensive examinations will be carried out during the visits. These include physical examinations, electrocardiograms (ECG) to check heart function and blood samples for further tests. In order to investigate how the tumour responds to the treatment, magnetic resonance tomography (MRT) and/or computer tomography (CRT) will be carried out, as well as X-ray examinations if necessary. This will take place every six weeks in the first six months and every twelve weeks thereafter.
Important criteria for taking part in the CHDM201X2103C study include:
- Diagnosis of advanced liposarcoma.
- Certain health restrictions or the use of certain medications may constitute criteria for exclusion.
- Pregnant or nursing women may not take part in the study.
The investigator can inform you of the exact inclusion and exclusion criteria for the CHDM201X2103C study.
If you have any questions about this study and would like to know where the next study site in your area is, please feel free to contact the information service at Novartis Pharma GmbH.
You can reach the Novartis information service:
Monday through Friday, 8 AM to 6 PM
Tel. 0800 – 54 55 000 (free of charge)
Please give the code word for this study, “Ulm” when calling.
Novartis is the sponsor of the study. The study has been approved by the ethics committee and notified to the competent authorities.