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
Condition: Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT03899467
Sponsor: Suzhou Kintor Pharmaceutical Inc,
Phase: Phase 2
- Age: minimum 18 Years maximum N/A
- Gender: Male
- 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 metastatic castrate resistant prostate cancer (mCRPC) who progressed after abiraterone or enzalutamide.
- 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.
- 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:
- 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.
- Discontinuation of enzalutamide or abiraterone less than 3 weeks prior to the start of study medication.
- Prior chemotherapy, radiation, sipuleucel-T or other experimental immunotherapy less than 3 weeks prior to the start of study medication
- Prior chemotherapies more than 1 line.
- 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 (See Appendix 4 for the list of medications).
- 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 (See Appendix 5 for drug details).
- Any condition that, in the opinion of the investigator, would impair the subject's ability to comply with study procedures.
View trial on ClinicalTrials.gov