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

NCT03899467 | Completed Phase 2 Results FDA Drug

• 1 other identifier: GT0918-US-1002
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 10

Brief 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. 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.

Conditions

Metastatic Castrate Resistant Prostate Cancer (mCRPC); Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (3)

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

  24 weeks

• Time to PSA Progression

  24 weeks

• PSA Maximum Change at 12 Weeks

  24 weeks

Study Arms (2)

Arm 1: 400 mg /day of GT0918

EXPERIMENTAL

Group 1: Post enzalutamide failure Group 2: Post abiraterone failure

Drug: GT0918

Arm 2: 500 mg/day of GT0918

EXPERIMENTAL

Group 1: Post enzalutamide failure Group 2: Post abiraterone failure

Drug: GT0918

Interventions

GT0918 DRUG

anti-tumor activity

Also known as: proxalutamide, androgen receptor antagonist

Arm 1: 400 mg /day of GT0918; Arm 2: 500 mg/day of GT0918

Eligibility Criteria

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

You may qualify if:

• 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:
• 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:

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Suzhou Kintor Pharmaceutical Inc,: lead

Study Sites (10)

University Cancer & Blood Center

Athens, Georgia, 30607, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Chesapeake Urology Research Associates

Towson, Maryland, 21204, United States

Location

G U Research Network

Omaha, Nebraska, 68130, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

New York Cancer & Blood Specialists

East Setauket, New York, 11733, United States

Location

New York Cancer & Blood Specialists

The Bronx, New York, 10469, United States

Location

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

Greenville Health System

Greenville, South Carolina, 29605, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

MeSH Terms

Interventions

proxalutamide; Androgen Receptor Antagonists

Intervention Hierarchy (Ancestors)

Androgen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Millie Gu
• Organization: Suzhou Kintor Pharmaceuticals,Inc.

PR@kintor.com.cn

+8651262639938

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 2, 2019
• Study Start: May 30, 2019
• Primary Completion: March 31, 2022
• Study Completion: September 19, 2022
• Last Updated: February 12, 2024
• Results First Posted: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)