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Trial record 31 of 1542 for:    Androgens

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

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ClinicalTrials.gov Identifier: NCT03600467
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Anthony Joshua, FRACP, St Vincent's Hospital, Sydney

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.


Condition or disease Intervention/treatment Phase
Solid Tumor Androgen Receptor Gene Overexpression Drug: SEVI-D (Seviteronel in combination with dexamthasone) Phase 2

  Show Detailed Description

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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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 5 years ]
    Number of Patients alive >= 5 years

  2. 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.

  3. 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

  4. Change in pain score measurements during treatment [ Time Frame: Through study completion, average 1 year ]
    Change from Baseline in BP-SF questionnaires



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. To be eligible for treatment in the study, patients must continue to meet all of the inclusion criteria and none of the exclusion criteria at the time of registration. Male or female patients, aged 18 years and older, with pathologically confirmed advanced GBM;
  2. Sufficient and accessible tissue for molecular screening;
  3. 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.

    1. Failure is defined as either progression of disease (clinical or radiological) or intolerance to standard therapy resulting in the discontinuation of the therapy.
    2. 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;
  4. ECOG performance status 0, 1 or 2;
  5. 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;
  6. Signed, written informed consent to participation in the molecular screening and treatment study.
  7. Received and failed all standard anticancer therapy or have documented unsuitability for any further standard therapy, if standard therapy exists;
  8. Clinical or radiological progression on or following last anticancer therapy;
  9. Adequate organ system function as assessed by the following minimal laboratory requirements (within 7 days prior to first administration of study drug):

    1. 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
    2. 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;
    3. renal function; serum creatinine ≤1.5xULN;
  10. Meet any additional inclusion criteria specified in the relevant study addendum;
  11. Signed, written informed consent to participation in the specific treatment study.
  12. AR-positive GBM confirmed by immunohistochemistry
  13. Able to comply with study requirements

Exclusion Criteria:

Exclusion criteria will include those relevant for screening but also include:

  1. Suitable for standard therapy or accepted standard care, if the patient has not been previously treated;
  2. Specific comorbidities or conditions (e.g. psychiatric) or concomitant medications which may contraindicate participation and/or interact with seviteronel, dexamethasone or the GnRH analogue;
  3. Other co-morbidities or conditions that may compromise assessment of key outcomes or in the opinion of the clinician, limit the ability of the patient to comply with the protocol;
  4. For non central nervous system (CNS) cancers, patients with symptomatic CNS involvement of his/her cancer. Subjects with stable neurological function, on stable doses of steroids/anti-epileptics over 4 weeks, and with no evidence of CNS progression within 12 weeks prior to study entry are eligible;
  5. History of another malignancy within 2 years prior to registration unless adequately treated and determined free of progressive and metastatic disease for at least 6 months. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible;
  6. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a barrier method of contraception (double barrier, if required).
  7. Known history of hypersensitivity to active or inactive components of seviteronel, dexamethasone, and/or GnRH analoge;
  8. Previous treatment with seviteronel or same class of agent;
  9. Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment:

    • 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;
    • Immunotherapy within 28 days prior to the first dose of study treatment;
    • 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);
  10. Administration of any investigational treatment within 30 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study treatment;
  11. Active prostate cancer requiring treatment.
  12. Active breast cancer requiring treatment.
  13. Symptomatic central nervous system cancer. Subjects with stable neurological function, on stable doses of steroids/anti-epileptics over 4 weeks prior to screening are eligible.
  14. 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.
  15. 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).
  16. Any medical condition that could preclude patient participation in the study, pose an undue medical hazard, or which could interfere with study results.
  17. Class III or IV Congestive Heart Failure as defined by the New York Heart Association functional classification system within the previous 6 months.
  18. Known active Human Immunodeficiency Virus, Hepatitis B, or Hepatitis C infections.

Information from the National Library of Medicine

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


Contacts
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Contact: Robert Kent +61 2 9355 5611 SVHS.CancerResearch@svha.org.au

Locations
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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         
Sponsors and Collaborators
St Vincent's Hospital, Sydney

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Responsible Party: Anthony Joshua, FRACP, Principle Investigator, St Vincent's Hospital, Sydney
ClinicalTrials.gov Identifier: NCT03600467     History of Changes
Other Study ID Numbers: START
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anthony Joshua, FRACP, St Vincent's Hospital, Sydney:
Androgen Receptor Positive
Seviteronel
Advanced Cancers
Additional relevant MeSH terms:
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Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs