Activity of Seviteronel in Patients With Androgen Receptor (AR)-Positive Glioblastoma (START)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03600467|
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : September 18, 2019
This study's purpose is to facilitate and expedite the clinical testing of SEVI-D in a population with advanced GBM that are androgen receptor (AR) positive.
Who is it for? You may be eligible for this study if you have a GBM with clinical/radiological progression on or following last anticancer therapy.
All participants will be screened to confirm if their GBM 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 GBM that are known to be human androgen receptor positive.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Androgen Receptor Gene Overexpression||Drug: SEVI-D (Seviteronel in combination with dexamthasone)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||START is an open-label, single-arm, multicentre Phase IIa signal-seeking trial.|
|Masking:||None (Open Label)|
|Official Title:||A Single-arm, Open-label, Signal-seeking, Phase IIa Trial of the Activity of Seviteronel in Patients With Androgen Receptor (AR)-Positive GBM|
|Actual Study Start Date :||August 13, 2018|
|Estimated Primary Completion Date :||August 30, 2020|
|Estimated Study Completion Date :||August 30, 2021|
|Experimental: Adrogen Postive Solid Tumours||
Drug: SEVI-D (Seviteronel in combination with dexamthasone)
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.
- Objective tumour response or the ratio of time-to-progression over the preceding period [ Time Frame: 1 year ]Assessing radiological images at each time point using either RECIST 1..1 or RANO criteria for disease progression.
- Overall survival (OS) [ Time Frame: 5 years ]Number of Patients alive >= 5 years
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.03. [ Time Frame: Through study completion, average 1 year ]The type and frequency of treatment-related adverse events as assessed by CTCAE v4.03.
- Change in quality of life measurements during treatment [ Time Frame: Through study completion, average 1 year ]Change from Baseline in EORTC QLQ-C30 v3 questionnaires
- Change in pain score measurements during treatment [ Time Frame: Through study completion, average 1 year ]Change from Baseline in BP-SF questionnaires
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03600467
|Contact: Robert Kent||+61 2 9355 5611||SVHS.CancerResearch@svha.org.au|
|Australia, New South Wales|
|St Vincent's Hospital||Recruiting|
|Darlinghurst, New South Wales, Australia, 2010|
|Contact: Robert Kent 02 9355 5611 SVHS.CancerResearch@svha.org.au|
|Principal Investigator: Anthony Joshua|