ACTRN12618001074280RecruitingPhase 2
A Single arm, open label, signal seeking, Phase II a trial of the activity of seviteronel in patients with androgen receptor (AR) positive solid tumours.
St Vincent's Hospital0 sites16 target enrollmentStarted: June 27, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 16
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
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.
Investigators
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