Patient enrollment

The ongoing Phase III SAPPHIRE study offers suitable patients with recurrent or refractory anaplastic astrocytoma the opportunity to have their tumor treated either with trabedersen (AP 12009) or standard chemotherapy. Patients will be randomly assigned to one of the two treatment groups. The main purpose of trabedersen (AP 12009) is to reactivate the immune system so that it can successfully combat the brain tumor. For detailed information on how trabedersen works please click here.

The SAPPHIRE study is being carried out in approximately 70 hospitals, and aims to recruit about 130 patients. This is a multinational study, which means that it will be carried out in 14 countries worldwide.

Patients who wish to participate in the SAPPHIRE study must fulfil a number of criteria. Please check the following lists of selected criteria with your physician to see whether you are eligible for the study:

You may be eligible for the SAPPHIRE study, if you:

1. are an adult between 18 and 70 years who has been diagnosed with anaplastic astrocytoma (WHO grade III),
2. have recurrent or refractory disease, i.e. the disease has progressed after:
   1. Initial surgery and radiotherapy (with or without simultaneous chemotherapy)
   2. Initial surgery and radiotherapy with simultaneous chemotherapy, followed by additional (adjuvant) chemotherapy
   3. Initial surgery and radiotherapy, followed by chemotherapy,
3. have not received more than one chemotherapy regimen. Radiation with simultaneous chemotherapy, followed by additional chemotherapy, is considered as one chemotherapy regimen,
4. are able to look after yourself without assistance on a day-to-day basis.

You will not be eligible for the SAPPHIRE study, if you:

1. are eligible to have your tumor surgically removed,
2. have had tumor surgery or other neurosurgery within the past month,
3. have had radiotherapy or gamma knife radiosurgery within the past 3 months,
4. have had chemotherapy, hormone therapy or any other therapy with apparent anticancer effects within the past 4–6 weeks,
5. have previously received a therapy that acts in a similar way to trabedersen [anti-TGF-ß-2 targeted therapy],
6. have cardiovascular problems such as uncontrolled hypertension, congestive heart failure, unstable angina, or poorly controlled arrhythmia, or have had a heart attack in the past 6 months,
7. have acute or chronic HIV, Hepatitis B or Hepatitis C infection or acute viral, bacterial or fungal infections.

If your physician thinks that you might be eligible for the SAPPHIRE study, please call the Antisense Pharma Helpline for more information about participating (German and English spoken) or your nearest study center. You may also contact us via email at info(a)gliomtherapie.de

Study centers with contact details will be updated here regularly, provided the person in charge has given his/her approval in writing.