Comparative Study of Abiraterone Acetate Tablets (I) or ZYTIGA® in Patients With Metastatic Castration-resistant Prostate Cancer
Study Details
Study Description
Brief Summary
To evaluate whether the efficacy of the abiraterone acetate tablets (I) is comparable to that of the ZYTIGA®) by comparing the serum testosterone concentrations on Day 9 and/or Day 10 after oral administration of the two formulations in patients with metastatic castration-resistant prostate cancer (mCRPC).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Abiraterone Acetate Tablets (I)
|
Drug: Abiraterone Acetate Tablets (I)
Abiraterone Acetate Tablets (I)
|
| Active Comparator: ZYTIGA®.
|
Drug: ZYTIGA®
ZYTIGA®
|
Outcome Measures
Primary Outcome Measures
- Serum testosterone concentration [Day 9/Day 10]
Blood Sample tested for Serum Testosterone Levels
Secondary Outcome Measures
- PSA level [Day 28, Day 56, and Day 84]
The serum total PSA level
- PSA-50 response rate [Day 28, Day 56, and Day 84]
The percentage of subjects with total serum PSA level decreased by 50% from the baseline value.
- Absolute testosterone concentration [Day 9/10, Day 28, Day 56, and Day 84]
The actual measured serum testosterone concentration.
- Testosterone inhibition rate [Day 9/10, Day 28, Day 56, and Day 84]
The percentage of subjects with a serum testosterone concentration of ≤ 1 ng/dL
- Steady-state minimum concentration of abiraterone [Day 9/10, Day 28, Day 56, and Day 84]
Defined as the plasma concentration of abiraterone
- Cmax, ss [Day 9]
Defined as the steady-state maximum concentration
- AUC0-τ [Day 9]
Defined as the area under the curve within the dosing interval at steady state
- Cmin, ss [Day 9]
Defined as the steady-state minimum concentration
- Cav, ss [Day 9]
Defined as the mean blood drug concentration during the dosing interval at steady state
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Males, ≥ 18 years old;
-
Histologically or cytologically diagnosed with prostate adenocarcinoma, without neuroendocrine or small cell characteristics, and having metastatic lesions with imaging evidence (such as positive bone scan or metastatic lesions on CT/MRI);
-
Serum testosterone level < 50 ng/dL or 1.7 nmol/L at the screening; subjects who have not undergone bilateral orchidectomy must plan to continue medication throughout the study to maintain therapy with effective GnRH agonist or antagonist;
-
Progression of prostate cancer as confirmed by diagnostic files, meeting one of the conditions for disease progression: 1) Biochemistry evidence of recurrence: continuous 3 rises of PSA (taken a minimum of 1 week apart) from a baseline measurement of at least 2 ng/mL, greater than 50% of the minimum value in 2 rises; 2) Radiographic progression: a clear evidence of new lesion; 2 or more new bone lesions appearing on bone scan; CT or MRI showing lesion progression (RECIST 1.1);
-
ECOG performance status score of ≤ 1;
-
Life expectancy of ≥ 6 months;
-
Major organs are functioning well
Exclusion Criteria:
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History of pituitary or adrenal dysfunction;
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Have used flutamide within 4 weeks before the first dose of study treatment, and bicalutamide or nilutamide within 6 weeks before the first dose of study treatment;
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Prior therapy with CYP17 inhibitors (such as abiraterone acetate, ketoconazole, TAK-700, etc.) or investigational drugs or marketed drugs of new androgen receptor antagonists (such as enzalutamide, apalutamide, SHR3680, ODM-201, and proxalutamide);
-
Have received 5-reductase inhibitors (such as finasteride and dutasteride), estrogen, progesterone, any herbal products (such as saw palmetto) that may decrease PSA levels, and radiotherapy within 4 weeks prior to the start of study medication;
-
Have previously received biotherapy or cytotoxic chemotherapy for mCRPC; patients who have completed docetaxel treatment for at least 1 year before enrollment can participate in screening;
-
Prostate cancer with moderate to severe pain symptoms, with a score of > 3 for Question 3 (the worst pain in the last 24 hours, 0-1 point means asymptomatic, 2-3 points mean mild symptoms) of the Brief Pain Inventory-Short Form (BPI-SF);
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With contraindications to the use of glucocorticoids, such as uncontrolled persistent infections or other conditions;
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Chronic diseases that require systemic corticosteroid therapy (> 10 mg/day prednisone or equivalent). Patients who have discontinued the administration or reduced the dose to < 10 mg within 14 days prior to the start of study treatment are eligible;
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Presence of abdominal fistula, gastrointestinal perforation, abdominal abscess, or other abnormal gastrointestinal function within 6 months before the first dose of study treatment, which may affect drug absorption as judged by the investigator;
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Presence of active heart disease within 6 months prior to the first dose of study treatment, including: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, left ventricular ejection fraction < 50%, and severe arrhythmia requiring treatment or New York Heart Association (NYHA) Class III-IV heart failure;
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Inability to swallow the whole tablet;
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Other conditions that make the patient unsuitable for the study as judged by the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fudan University Shanghai Cancer Center | Shanghai | Shanghai | China | 200433 |
Sponsors and Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ABTL-PD-01