None listed
Conditions
Brief summary
This study's purpose is to facilitate and expedite the clinical testing of SEVI-D in a population with advanced cancer that are androgen receptor (AR) positive. Who is it for? You may be eligible for this study if you have a solid tumour with clinical/radiological progression on or following last anticancer therapy. There study has a focus on, but not exclusive to, rare or neglected cancers. Study details All participants will be screened to confirm if their solid tumour is AR positive by the study team. If eligible, participants will receive the medications of Serivteronel and Dexamethasone (also known as SEVI-D) by oral tablets continuously per cycle (4 weeks). Participants will be asked to have blood tests, scans, complete questionnaire and regularly meet with the study doctor and team. It is hoped this research will demonstrate this treatment could be beneficial for the treatment of cancers that are known to be human androgen receptor positive.
Interventions
Use of SEVI-D (Serivteronel and dexamethasone) in the treatment of androgen receptor positive solid tumours.
Serivteronel will be administered orally at 450 mg (3 tables) once daily. It will be given in combination with one oral tablet of 0.5 mg tablet of Dexamethosone. SEVI-D will be continuously administered daily while on the study.
Clinical and safety assessments are scheduled every 4 weeks during the study and then every 8 weeks after the end of the safety follow up period of the stud
Use of SEVI-D (Serivteronel and dexamethasone) in the treatment of androgen receptor positive solid tumours. Serivteronel will be administered orally at 450 mg (3 tables) once daily. It will be given in combination with one oral tablet of 0.5 mg tablet of Dexamethosone. SEVI-D will be continuously administered daily while on the study. Clinical and safety assessments are scheduled every 4 weeks during the study and then every 8 weeks after the end of the safety follow up period of the study. There is no set duration of administration and treatment will continue until the Clinical and/or disease assessments show no therapeutic benefit. The hospital pharmacy will keep a drug accountability record and patients will be asked to return any unused medication and empty drug containers.
Sponsors
St Vincent's Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Received and failed all standard anticancer therapy or have documented unsuitability for any further standard therapy (if standard therapy exists) 2. Clinical or radiological progression on or following last anticancer therapy 3. Patients with AR-positive solid tumours as confirmed by immunohistochemistry 4. Adequate organ system function 5, Ability to comply with study requirements
Exclusion criteria
1. Contraindications to investigational product, as listed in the study addendum and outlined in the Investigator Brochure appended to each study module 2. Known history of hypersensitivity to active or inactive components of investigational product 3. Previous treatment with the same agent or same class of agent 4. Treatment with any of the following anticancer therapies prior to the first dose of study treatment: o Radiation therapy, surgery or tumour embolization within 14 days prior to the first dose of study treatment. Palliative radiotherapy (for analgesia) is acceptable only if the irradiated field does not include target lesions; o Immunotherapy within 28 days prior to the first dose of study treatment; o Chemotherapy, biologic therapy, or hormonal therapy within 14 days or 5 half lives of a drug prior to the first dose of study treatment or until recovery from previous therapy (whichever is longer) 5. Administration of any investigational treatment within 30 days or 5 half lives (whichever is longer) prior to receiving the first dose of study treatment; 6. Any additional exclusion criteria specified in the relevant study addendum. 7. Active prostate cancer requiring treatment. 8. Active breast cancer requiring treatment. 9. Symptomatic central nervous system cancer. Subjects with stable neurological function, on stable doses of steroids/antiepileptics over 4 weeks prior to screening are eligible. 10. Corrected QT interval by the Fridericia correction formula (QTcF) on the screening electrocardiogram (ECG) >470 msec. If the screening ECG QTcF interval is >470 msec, it may be repeated once, and if the repeat ECG is <470 msec, the patient may be enrolled. 11. Clinically significant cardiac arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, torsades de pointes, second degree or third degree atrioventricular heart block without a permanent pacemaker in place). 12. Any medical condition that could preclude patient participation in the study, pose an undue medical hazard, or which could interfere with study results. 13. Class III or IV Congestive Heart Failure as defined by the New York Heart Association functional classification system within the previous 6 months. 14. Known active Human Immunodeficiency Virus, Hepatitis B, or Hepatitis C infections.
Outcome results
None listed