Activity of Seviteronel in Patients With Androgen Receptor (AR)-Positive Glioblastoma

NCT03600467 | Terminated Phase 2 DMC

• 1 other identifier: START
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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. Study details: 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.

Conditions

Solid Tumor; Androgen Receptor Gene Overexpression

Keywords

Androgen Receptor Positive; Seviteronel; Advanced Cancers

Outcome Measures

Primary Outcomes (1)

• Objective tumour response or the ratio of time-to-progression over the preceding period

  Assessing radiological images at each time point using either RECIST 1..1 or RANO criteria for disease progression.

  1 year

Secondary Outcomes (4)

• Overall survival (OS)

  5 years

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.03.

  Through study completion, average 1 year

• Change in quality of life measurements during treatment

  Through study completion, average 1 year

• Change in pain score measurements during treatment

  Through study completion, average 1 year

Study Arms (1)

Adrogen Postive Solid Tumours

EXPERIMENTAL

Drug: SEVI-D (Seviteronel in combination with dexamthasone)

Interventions

SEVI-D (Seviteronel in combination with dexamthasone) DRUG

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.

Adrogen Postive Solid Tumours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Sufficient and accessible tissue for molecular screening;
• Patients receiving their last line of standard treatment or who have received and failed all standard anticancer therapy (where standard therapy exists) or have documented unsuitability for any further standard anticancer therapy Poor prognosis cancers or cancers with low expected response rate to standard treatment (in the opinion of the investigator and based on available evidence) may be screened on an earlier line of treatment.
• Failure is defined as either progression of disease (clinical or radiological) or intolerance to standard therapy resulting in the discontinuation of the therapy.
• Documented unsuitability for further standard therapy includes known hypersensitivity, organ dysfunction or other patient factors that would make therapy unsuitable in the judgement of the responsible investigator;
• ECOG performance status 0, 1 or 2;
• Willing and potentially able to comply with study requirements, including treatment, timing and/or nature of required assessments; It is the intention to screen patients who are in principle wishing to take part in the START study if they are found to have an appropriate tumour biomarker and are still eligible for enrolment at the time of the treatment phase;
• Signed, written informed consent to participation in the molecular screening and treatment study.
• Received and failed all standard anticancer therapy or have documented unsuitability for any further standard therapy, if standard therapy exists;
• Clinical or radiological progression on or following last anticancer therapy;
• Adequate organ system function as assessed by the following minimal laboratory requirements (within 7 days prior to first administration of study drug):
• bone marrow function; platelets ≥ 100 x 109/L, ANC ≥ 1.5 x 109/L, and haemoglobin ≥9g/dL (5.6mmol/L); white blood cell count ≥3,000 cells/μL
• liver function; ALT/AST ≤ 3 x ULN (in the absence of liver metastases, ≤ 5 x ULN for patients with liver involvement) and total bilirubin ≤1.5xULN;
• renal function; serum creatinine ≤1.5xULN;
• Signed, written informed consent to participation in the specific treatment study.
• AR-positive GBM confirmed by immunohistochemistry

Sponsors & Collaborators

• St Vincent's Hospital, Sydney: lead

Study Sites (1)

St Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

MeSH Terms

Interventions

seviteronel

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: START is an open-label, single-arm, multicentre Phase IIa signal-seeking trial.

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: July 26, 2018
• Study Start: August 13, 2018
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: March 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)