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the Safety and Tolerability of Proxalutamide (GT0918) in Subjects With Metastatic Castrate Resistant Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03899467
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Suzhou Kintor Pharmaceutical Inc,

Brief Summary:

This study is an open-label, randomized, expanded/phase II study in subjects with metastatic castrate resistant prostate cancer (mCRPC) who progressed after either abiraterone or enzalutamide.

The objective of the study is to evaluate the safety and tolerability of proxalutamide and determine the RP2D for Ph III and/or other confirming studies.

Subjects will be randomized into the 2 treatment arms.


Condition or disease Intervention/treatment Phase
Metastatic Castrate Resistant Prostate Cancer (mCRPC) Drug: GT0918 Phase 2

Detailed Description:

This study is an open-label, randomized, expanded/phase II study in subjects with metastatic castrate resistant prostate cancer (mCRPC) who progressed after either abiraterone or enzalutamide. All subjects will be randomized to take 400 mg or 500 mg of GT0918 by oral administration once daily on an empty stomach (2-3 hours after a meal) for initial treatment of 6 months. Randomization of subjects will be stratified by prior therapy (abiraterone or enzalutamide).

Subjects will continue treatment with GT0918 (proxalutamide) at their assigned dose on an empty stomach until disease progression, intolerable toxicities (AEs), or withdrawn consent. A post-treatment period of 4 weeks will commence that concludes with an end-of-study visit.

Disease progression will be assessed by three methods over the duration of the study. Subjects will be assessed for biochemical (PSA) progression measured monthly, as well as radiographic progression by CT scan or/and bone progression by radionuclide bone scan every 12-weeks. Progressive disease will be considered on the occurrence of the first assessed progression event. Subjects with PSA progression only may continue the study until radiographic or bone progression at the discretion of the Investigator and with agreement by the sponsor or their authorized medical monitor.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extended/Phase 2, Multi-Center, Randomized, Open-Label Study to Evaluate the Safety and Tolerability of GT0918 in Subjects With Metastatic Castrate Resistant Prostate Cancer (mCRPC) Who Failed Either Abiraterone or Enzalutamide
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Arm 1: biological dose group

400mg/day of proxalutamide

Group 1: Post enzalutamide failure

Group 2: Post abiraterone failure

Drug: GT0918
anti-tumor activity
Other Names:
  • proxalutamide
  • androgen receptor antagonist

Experimental: Arm 2: MTD dose group

500mg/day of proxalutamide

Group 1: Post enzalutamide failure

Group 2: Post abiraterone failure

Drug: GT0918
anti-tumor activity
Other Names:
  • proxalutamide
  • androgen receptor antagonist




Primary Outcome Measures :
  1. recommended Phase 2 dose (RP2D) [ Time Frame: 6 month ]
    determine the RP2D for Ph III and/or other confirming studies

  2. Number of Patients With Toxicity of proxalutamide [ Time Frame: 6 month ]
    Only adverse events that are possibly, probably or definitely related to study drug are reported


Secondary Outcome Measures :
  1. >50% PSA suppression [ Time Frame: 12 weeks ]
    To evaluate proportion of subjects with a > 50% PSA suppression at 12 weeks

  2. percentage of radiographic disease progression [ Time Frame: 6 and 12 months ]
    To evaluate percentage of radiographic disease progression at 6 and 12 months

  3. radiographic and bone progression time [ Time Frame: 6 month ]
    To evaluate time to radiographic and bone progression

  4. the time to PSA progression [ Time Frame: 6 month ]
    To evaluate the time to PSA progression

  5. exploratory biomarkers: cell free circulating tumor DNA (ct-DNA)/RNA (ct-RNA) [ Time Frame: 6 month ]
    To identify exploratory biomarkers to characterize androgen receptor (AR) inhibition and/or down-regulation by proxalutamide

  6. exploratory biomarkers: Circulating tumor cells (CTC) [ Time Frame: 6 months ]
    anti-tumor activities



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

Inclusion Criteria:

  1. Written informed consent obtained prior to any study-related procedure being performed.
  2. Subjects at least 18 years of age or older at the time of consent.
  3. Subjects with histologically confirmed metastatic castrate resistant prostate cancer (mCRPC) who progressed after abiraterone or enzalutamide.
  4. Ongoing androgen deprivation therapy with a luteinizing hormone-releasing hormone (LHRH) "super-agonist" or antagonist, or bilateral orchiectomy and serum testosterone level < 50 ng/dL (< 0.5 ng/mL, < 1.7 nmol/L) at screening.
  5. Metastatic disease documented by computed tomography (CT)/magnetic resonance imaging (MRI) or bone scan.
  6. Progressive disease despite hormonal treatment with abiraterone or enzalutamide, but not both. One line of chemotherapy is eligible. Progressive disease is defined by 1 or more of the following criteria:

    1. Subjects with a rising prostate specific antigen (PSA) value > 5 ng/mL in at least 2 measurements, at least 1 week apart. If the confirmatory PSA value is less than the screening PSA value, then an additional test for the rising PSA is required to document progression.
    2. Subjects with measurable disease, progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
    3. Subjects with metastatic bone disease, progression defined by 2 or more new lesions in a radionuclide bone scan.
  7. ECOG performance status of 0-1
  8. Screening blood counts of the following:

    1. Absolute neutrophil count ≥ 1500/μL
    2. Platelets ≥ 100,000/μL
    3. Hemoglobin > 9 g/dL (if asymptomatic).
  9. Screening chemistry values of the following:

    1. Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 × upper limit of the normal reference range (ULN)
    2. Total bilirubin ≤ 2 × ULN
    3. Creatinine ≤ 1.5 × ULN
    4. Albumin > 2.8 g/dL.
  10. At screening, life expectancy of at least 6 months.
  11. Subjects whose partners are women of childbearing potential (WOCBP) must use an adequate method of birth control while on study drug and for at least 3 months after discontinuation of study drug.
  12. Subject is willing and able to comply with all protocol required visits and assessments.

Exclusion Criteria:

  1. Discontinuation of enzalutamide or abiraterone less than 3 weeks, prior to the start of study medication.
  2. Prior chemotherapy, radiation, sipuleucel-T or other experimental immunotherapy less than 3 weeks prior to the start of study medication
  3. Prior chemotherapies more than 1 line.
  4. Ongoing acute treatment-related toxicity associated with a previous therapy greater than grade 1 except for grade 2 alopecia or neuropathy.
  5. History of impaired adrenal gland function (e.g., Addison's disease, Cushing's syndrome).
  6. Known gastrointestinal disease or condition that affects the absorption of proxalutamide.
  7. History of congestive heart failure New York Heart Association (NYHA) class III or IV or uncontrolled hypertension at screening.
  8. History or family history of long QT syndrome.
  9. History of other malignancy within the previous 3 years, except basal cell or squamous cell carcinoma, or non-muscle invasive bladder cancer.
  10. Use of systemic glucocorticoid (e.g., prednisone, dexamethasone) within 14 days prior to the start of study medication. Inhaled or topical steroids are allowed.
  11. Co-administration of CYP3A4 ligands that serve as substrates or induce or inhibit the enzyme.
  12. Prior use of any herbal products known to decrease PSA levels (e.g., PC-SPES or saw palmetto) within 30 days prior to the start of study medication.
  13. Major surgery within 30 days prior to the start of study medication.
  14. Blood transfusion (including blood products) within 1 week of screening.
  15. Serious persistent infection within 14 days prior to the start of study medication.
  16. Serious concurrent medical condition including CNS disorders.
  17. Previous history of difficulty swallowing capsules.
  18. Known hypersensitivity to GT0918 or its excipients.
  19. Any condition that, in the opinion of the investigator, would impair the subject's ability to comply with study procedures.

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): NCT03899467


Contacts
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Contact: Phoebe Zhang, PhD +1-984-208-1255 pzhang@kintor.com.cn

Locations
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United States, Maryland
Chesapeake Urology Research Associates
Towson, Maryland, United States, 21204
United States, Nebraska
G U Research Network
Omaha, Nebraska, United States, 68130
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
United States, New York
North Shore Hematology Oncology Associates
East Setauket, New York, United States, 11733
United States, Ohio
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
Sponsors and Collaborators
Suzhou Kintor Pharmaceutical Inc,
Investigators
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Study Director: Phoebe Zhang, PhD Suzhou Kintor Pharmaceuticals Inc

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Responsible Party: Suzhou Kintor Pharmaceutical Inc,
ClinicalTrials.gov Identifier: NCT03899467     History of Changes
Other Study ID Numbers: GT0918-US-1002
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Androgen Receptor Antagonists
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs