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Metastatic Castrate Resistant Prostate Cancer (mCRPC)Phase 2NCT03899467

The Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC

A Phase 2 study testing GT0918 in people with Metastatic Castrate Resistant Prostate Cancer (mCRPC) and Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), run by Suzhou Kintor Pharmaceutical Inc, at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This was a multiple-center, open-label, randomized, daily dose, two-sequence, expanded/phase II study in subjects with mHSPC or mCRPC who progressed after either abiraterone or enzalutamide treatment. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
GT0918
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
10 sitesUnited States
Study dates
30 May 2019to 19 Sep 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent obtained prior to any study-related procedure being performed.
  • Subjects at least 18 years of age or older at the time of consent.
  • Subjects with histologically confirmed mHSPC or mCRPC who received abiraterone or enzalutamide for the hormonal treatment of 6 months or longer.
  • Subjects with mHSPC are required to have no prior ADT (androgen deprivation therapy) or orchiectomy. For mCRPC, ongoing androgen deprivation therapy with a luteinizing hormonereleasing hormone (LHRH) "super-agonist" or antagonist, or bilateral orchiectomy. Serum testosterone level is < 50 ng/dL (< 0.5 ng/mL, < 1.7 nmol/L) at screening.
  • Metastatic disease documented by computed tomography (CT)/magnetic resonance imaging (MRI) or bone scan.
  • Progressive disease despite hormonal treatment with abiraterone or enzalutamide, but not both. However, if either of these 2 drugs was used less than 3 months due to toxicity, the patient is eligible. One line of chemotherapy is eligible. Progressive disease is defined by 1 or more of the following criteria:
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  • Subjects with a rising prostate specific antigen (PSA) value > 2 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.
  • Subjects with measurable disease, progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  • Subjects with metastatic bone disease, progression defined by 2 or more new lesions in a radionuclide bone scan.
  • ECOG performance status of 0-1
  • Screening blood counts of the following:
  • Absolute neutrophil count ≥ 1500/μL
  • Platelets ≥ 100,000/μL
  • Hemoglobin > 9 g/dL (if asymptomatic).
  • Screening chemistry values of the following:
  • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 × upper limit of the normal reference range (ULN)
  • Total bilirubin ≤ 2 × ULN
  • Creatinine ≤ 1.5 × ULN
  • Albumin > 2.8 g/dL.
  • At screening, life expectancy of at least 6 months.
  • 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.
  • Subject is willing and able to comply with all protocol required visits and assessments.

Who cannot join

  • Discontinuation of enzalutamide or abiraterone less than 3 weeks prior to the start of study medication.
  • Prior chemotherapy and experimental therapy (Poly (ADP-ribose) polymerase (PARP) or checkpoint inhibitor)
  • Ongoing acute treatment-related toxicity associated with a previous therapy greater than grade 1 except for grade 2 alopecia or neuropathy.
  • History of impaired adrenal gland function (e.g., Addison's disease, Cushing's syndrome).
  • Known gastrointestinal disease or condition that affects the absorption of proxalutamide.
  • History of congestive heart failure New York Heart Association (NYHA) class III or IV or uncontrolled hypertension at screening.
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  • History or family history of long QT syndrome, or ECG corrected QT interval equal to and over 500 ms (CTCAE grade 2) at baseline.
  • History of other malignancy within the previous 3 years, except basal cell or squamous cell carcinoma, or non-muscle invasive bladder cancer.
  • Use of systemic glucocorticoid (e.g., prednisone, dexamethasone) within 14 days prior to the start of study medication. Inhaled or topical steroids are allowed.
  • Co-administration of CYP3A4 ligands that serve as substrates or induce or inhibit the enzyme.
  • 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.
  • Major surgery within 30 days prior to the start of study medication.
  • Blood transfusion (including blood products) within 1 week of screening.
  • Serious persistent infection within 14 days prior to the start of study medication.
  • Serious concurrent medical condition including CNS disorders.
  • Previous history of difficulty swallowing capsules.
  • Known hypersensitivity to GT0918 or its excipients.
  • Any condition that, in the opinion of the investigator, would impair the subject's ability to comply with study procedures.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • University Cancer & Blood Center

    Athens, Georgia, 30607

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

  • New York Cancer & Blood Specialists

    East Setauket, New York, 11733

  • Greenville Health System

    Greenville, South Carolina, 29605

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • G U Research Network

    Omaha, Nebraska, 68130

  • New York Cancer & Blood Specialists

    The Bronx, New York, 10469

  • Chesapeake Urology Research Associates

    Towson, Maryland, 21204

Other trials in United States

About this study

Official title: An Multi-Center, Randomized, Open-Label Study to Evaluate the Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC Who Failed Either Abiraterone or Enzalutamide

This was a multiple-center, open-label, randomized, daily dose, two-sequence, expanded/phase II study in subjects with mHSPC or mCRPC who progressed after either abiraterone or enzalutamide treatment.

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.

Read the detailed description

This study is an open-label, randomized, expanded/phase II study in subjects with mHSPC or 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.

Being tested
GT0918

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GT0918Drug

    Also called proxalutamide, androgen receptor antagonist

    anti-tumor activity

Study groups in NCT03899467
Study groupRoleWhat they receive
Arm 1: 400 mg /day of GT0918ExperimentalGroup 1: Post enzalutamide failure Group 2: Post abiraterone failure
Receives: Drug: GT0918
Arm 2: 500 mg/day of GT0918ExperimentalGroup 1: Post enzalutamide failure Group 2: Post abiraterone failure
Receives: Drug: GT0918

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the Safety and Tolerability of GT0918 and Select the RP2D for Future Clinical Trial Study.

    To evaluate the safety and tolerability of GT0918 assessed by AEs, SAEs between 400 mg arm vs. 500 mg arm with mHSPC or mCRPC who failed either abiraterone or enzalutamide treatment The percetage of AE and SAE would be evaluated in subjects with mHSPC and to determine the recommended Phase II dose (RP2D) over 6 months or longer treatment

    Measured: Average of 24 weeks, up to a maximum of 30 weeks

Secondary outcomes (3)

  1. The Percentage of Subjects Achieving a ≥50% Reduction in PSA at 12 Weeks and 24 Weeks

    The percentage of subjects achieving a ≥50% reduction in PSA at 3 months (12 weeks) as compared to baseline (study entry) was determined.

    Measured: 24 weeks

  2. Time to PSA Progression

    Time to PSA Progression in 400mg group and 500mg group

    Measured: 24 weeks

  3. PSA Maximum Change at 12 Weeks

    The percentage of change of PSA from baseline at Week 12 was calculated. Maximum percentage change of PSA from baseline at any time was calculated.

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2019
  2. Study start30 May 2019
  3. Primary completion31 Mar 2022
  4. Study completion19 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03899467
Sponsor's protocol ID
GT0918-US-1002
Status last verified
Dec 2023
First submitted
27 Mar 2019
Last updated
12 Feb 2024
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GT0918 in people with Metastatic Castrate Resistant Prostate Cancer (mCRPC) and Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), run by Suzhou Kintor Pharmaceutical Inc, at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the Safety and Tolerability of GT0918 and Select the RP2D for Future Clinical Trial Study. (time frame: Average of 24 weeks, up to a maximum of 30 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03899467.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.

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