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Abiraterone Post Ketoconazole for Prostate Cancer
Phase 2 trial testing Abiraterone acetate in Prostate Cancer in 42 participants. Completed in 14 March 2016.
| Lead sponsor | University of California, San Francisco |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 10 September 2010 |
| Primary completion | 4 January 2013 |
| Estimated completion | 14 March 2016 |
| Sites | 2 locations across United States |
University of California, San Francisco
18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
number of patients with ≥ 30% PSA decline after 12 weeks of abiraterone treatment
| Group | Value | 95% CI |
|---|---|---|
| Abiraterone Acetate | 20 |
| Group | Value | 95% CI |
|---|---|---|
| Abiraterone Acetate | 16 | 4 – 71 |
| Group | Value | 95% CI |
|---|---|---|
| Abiraterone Acetate | 19 |
Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Abiraterone Acetate |
|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | — |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | — |
| Constitutional Symptoms - Other (Specify, __) | General disorders | — |
| Fatigue (asthenia, lethargy, malaise) | General disorders | — |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | — |
| Weight loss | General disorders | — |
| Death not associated with CTCAE term - Sudden death | General disorders | — |
| Dehydration | Gastrointestinal disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Infection - Other (Specify, __) | Infections and infestations | — |
| Infection with unknown ANC - Urinary tract NOS | Infections and infestations | — |
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | — |
| Fracture | Musculoskeletal and connective tissue disorders | — |
| Pain - Back | General disorders | — |
| Secondary Malignancy - possibly related to cancer treatment (Specify, __) | General disorders | — |
| Reaction | System | Abiraterone Acetate |
|---|---|---|
| Fatigue (asthenia, lethargy, malaise) | General disorders | — |
| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders | — |
| Hemoglobin | Blood and lymphatic system disorders | — |
| Hypertension | Cardiac disorders | — |
| Pain - Back | General disorders | — |
| Alkaline phosphatase | Metabolism and nutrition disorders | — |
| Pain - Pelvis | General disorders | — |
| Anorexia | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | — |
| Pain - Extremity-limb | General disorders | — |
| Pain - Other (Specify, __) | General disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | — |
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | — |
| Pain - Pain NOS | General disorders | — |
| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | — |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | — |
| Hot flashes/flushes | Endocrine disorders | — |
| Fracture | Musculoskeletal and connective tissue disorders | — |
| Pain - Joint | General disorders | — |
| Pain - Muscle | General disorders | — |
| Constitutional Symptoms - Other (Specify, __) | General disorders | — |
| Weight loss | General disorders | — |
| Bruising (in absence of Grade 3 or 4 thrombocytopenia) | Skin and subcutaneous tissue disorders | — |
| Infection - Other (Specify, __) | Infections and infestations | — |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | — |
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | — |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower | Musculoskeletal and connective tissue disorders | — |
| Mood alteration - Depression | Nervous system disorders | — |
| Uveitis | Eye disorders | — |
| Platelets | Blood and lymphatic system disorders | — |
| Vasovagal episode | Cardiac disorders | — |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | — |
| Weight gain | General disorders | — |
| Dermatology/Skin - Other (Specify, __) | Skin and subcutaneous tissue disorders | — |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis) | Infections and infestations | — |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized | Musculoskeletal and connective tissue disorders | — |
| Musculoskeletal/Soft Tissue - Other (Specify, __) | Musculoskeletal and connective tissue disorders | — |
| Pain - Tumor pain | General disorders | — |
Most-reported serious reactions: Hemoglobin, Dyspnea (shortness of breath), Constitutional Symptoms - Other (Specify, __), Fatigue (asthenia, lethargy, malaise), Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L), Weight loss, Death not associated with CTCAE term - Sudden death, Dehydration.
Data from ClinicalTrials.gov NCT01199146 adverse events section.
This is a phase II, open label, single center study to evaluate the efficacy of abiraterone acetate (CB7630) administered to patients with castrate resistant prostate cancer who have experienced disease progression on ketoconazole. It is hypothesized that abiraterone will be active in patients who have experienced disease progression on ketoconazole
3 peer-reviewed publications reference this trial (live from Europe PMC):
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