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Trial registered on ANZCTR


Registration number
ACTRN12618001074280
Ethics application status
Approved
Date submitted
4/06/2018
Date registered
27/06/2018
Date last updated
19/11/2019
Date data sharing statement initially provided
19/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Intervention study assessing the novel use of seviteronel in androgen receptor positive cancers
Scientific title
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.
Secondary ID [1] 295085 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The START Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid cancers 308146 0
Condition category
Condition code
Cancer 307181 307181 0 0
Bladder
Cancer 307182 307182 0 0
Bowel - Anal
Cancer 307183 307183 0 0
Cervical (cervix)
Cancer 307184 307184 0 0
Head and neck
Cancer 307185 307185 0 0
Kidney
Cancer 307186 307186 0 0
Liver
Cancer 307187 307187 0 0
Lung - Non small cell
Cancer 307188 307188 0 0
Other cancer types
Cancer 307189 307189 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 307190 307190 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 301417 0
Treatment: Drugs
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306137 0
To test the clinical activity of novel targeted treatments and/or indications as measured by objective tumour response or the ratio of time-to-progression on study over the preceding period using medical imaging tools (CT, MRI, PET or 18F-FDG PET).
Timepoint [1] 306137 0
Assessments will occur at pre-treatment and then routine imaging will occur every 8 weeks until disease progression. Radiological images will be assessed at each time point using either RECIST 1..1 or RANO criteria for disease progression
Secondary outcome [1] 347684 0
To determine overall survival (OS)
Timepoint [1] 347684 0
Death from any cause assessed for up to 5 years. This will be followed up by assessing medical records, state-based cancer registries and/or the national mortality registry (AIHW)
Secondary outcome [2] 347685 0
To determine composite safety and tolerability of treatment using CTCAE 4.03 criteria
Timepoint [2] 347685 0
Assessments will occur prior to start of treatment, at the end of the first cycle, each cycle thereafter and a 30 day follow up period at study discontinuation.
Secondary outcome [3] 347686 0
To determine health related quality of life during treatment using EORTC QLQ-C30 v3 and BP-SF questionnaires.
Timepoint [3] 347686 0
Assessments will occur prior to start of treatment, at the end of the first cycle, each cycle thereafter and 8 weekly after study discontinuation.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
n/a
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Once consent obtained, patients will be pre-screened to determine if androgen receptor positive (AR>0)
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The study will screen up to 200 patient to achieve a enrolment of 16 patients on treatment. We envisage that studies with =3/16 responding patients, will in general be sufficiently interesting to investigate further.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2018
Actual
13/08/2018
Date of last participant enrolment
Anticipated
31/07/2020
Actual
Date of last data collection
Anticipated
31/07/2021
Actual
Sample size
Target
16
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11063 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 22865 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 299667 0
Commercial sector/Industry
Name [1] 299667 0
Innocrin Pharmaceuticals Inc
Country [1] 299667 0
United States of America
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
370 Victoria Street
Darlinghurst
NSW 2010

Country
Australia
Secondary sponsor category [1] 298995 0
None
Name [1] 298995 0
Address [1] 298995 0
Country [1] 298995 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300564 0
St Vincent's Hospital HREC (EC00140)
Ethics committee address [1] 300564 0
St Vincent's Research Office
Translational Research Centre
97-105 Boundary St
Darlinghurst
NSW 2010
Ethics committee country [1] 300564 0
Australia
Date submitted for ethics approval [1] 300564 0
12/04/2018
Approval date [1] 300564 0
02/05/2018
Ethics approval number [1] 300564 0
HREC/18/SVH/52

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84082 0
Dr Hao-Wen Sim
Address 84082 0
The Kinghorn Cancer Centre
370 Victoria St
Darlinghurst
NSW 2010
Country 84082 0
Australia
Phone 84082 0
+61 2 9355 5711
Fax 84082 0
+61 2 9355 5735
Email 84082 0
[email protected]
Contact person for public queries
Name 84083 0
Robert Kent
Address 84083 0
The Kinghorn Cancer Centre
370 Victoria St
Darlinghurst
NSW 2010
Country 84083 0
Australia
Phone 84083 0
+61 2 9355 5711
Fax 84083 0
+61 2 9355 5735
Email 84083 0
[email protected]
Contact person for scientific queries
Name 84084 0
Robert Kent
Address 84084 0
The Kinghorn Cancer Centre
370 Victoria St
Darlinghurst
NSW 2010
Country 84084 0
Australia
Phone 84084 0
+61 2 9355 5711
Fax 84084 0
+61 2 9355 5735
Email 84084 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not apart of ethics approval


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.