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Abiraterone Acetate and Prednisone With or Without Veliparib in Treating Patients With Metastatic Castration-Resistant Prostate Cancer
Phase 2 trial testing Abiraterone Acetate in Castration-Resistant Prostate Carcinoma in 159 participants. Completed in 23 April 2020.
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 159 |
| Start date | 30 March 2012 |
| Primary completion | 23 October 2019 |
| Estimated completion | 23 April 2020 |
| Sites | 14 locations across United States |
National Cancer Institute (NCI)
18 and older, male only, with Castration-Resistant Prostate Carcinoma or Recurrent Prostate Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
50% or greater decline in PSA from baseline.
| Group | Value | 95% CI |
|---|---|---|
| Arm I (Abiraterone Acetate and Prednisone) | 46 | |
| Arm II (Abiraterone Acetate, Prednisone, and Veliparib) | 55 |
Change in PSA from baseline to 12 weeks
| Group | Value | 95% CI |
|---|---|---|
| Arm I (Abiraterone Acetate and Prednisone) | -41.1 | ± 15.7 |
| Arm II (Abiraterone Acetate, Prednisone, and Veliparib) | -52.9 | ± 26.5 |
Overall response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Group | Value | 95% CI |
|---|---|---|
| Arm I (Abiraterone Acetate and Prednisone) | 18 | |
| Arm II (Abiraterone Acetate, Prednisone, and Veliparib) | 24 |
Time from randomization to disease progression or death.
| Group | Value | 95% CI |
|---|---|---|
| Arm I (Abiraterone Acetate and Prednisone) | 10.1 | 8.2 – 13.8 |
| Arm II (Abiraterone Acetate, Prednisone, and Veliparib) | 11.0 | 8.1 – 13.6 |
Grade 4 or greater toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 at least possibly related to treatment.
| Group | Value | 95% CI |
|---|---|---|
| Arm I (Abiraterone Acetate and Prednisone) | 1 | |
| Arm II (Abiraterone Acetate, Prednisone, and Veliparib) | 3 |
Time frame: 30 days after completion of study treatment (up to 42 months).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm I (Abiraterone Acetate… | Arm II (Abiraterone Acetat… |
|---|---|---|---|
| Vomiting | Gastrointestinal disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Heart failure | Cardiac disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Restlessness | Psychiatric disorders | — | — |
| Thromboembolic event | Vascular disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Chest pain - cardiac | Cardiac disorders | — | — |
| Colonic obstruction | Gastrointestinal disorders | — | — |
| Confusion | Psychiatric disorders | — | — |
| Cystitis noninfective | Renal and urinary disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| General disorders and administration site conditions - Other, specify | General disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Hip fracture | Injury, poisoning and procedural complications | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Hypoglycemia | Metabolism and nutrition disorders | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Arm I (Abiraterone Acetate… | Arm II (Abiraterone Acetat… |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Hot flashes | Vascular disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Pain | General disorders | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Alkaline phosphatase increased | Investigations | — | — |
| Edema limbs | General disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Urinary frequency | Renal and urinary disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Bone pain | Musculoskeletal and connective tissue disorders | — | — |
| Bruising | Injury, poisoning and procedural complications | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Platelet count decreased | Investigations | — | — |
| Hyperkalemia | Metabolism and nutrition disorders | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Weight loss | Investigations | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | — | — |
| Blood bilirubin increased | Investigations | — | — |
| Creatinine increased | Investigations | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Urinary incontinence | Renal and urinary disorders | — | — |
| Weight gain | Investigations | — | — |
Most-reported serious reactions: Vomiting, Atrial fibrillation, Dehydration, Fall, Heart failure, Insomnia, Nausea, Restlessness.
Data from ClinicalTrials.gov NCT01576172 adverse events section.
This randomized phase II trial studies abiraterone acetate and prednisone together with veliparib to see how well it works compared to abiraterone acetate and prednisone alone in treating patients with castration-resistant prostate cancer that has spread from the primary site to other places in the body. Androgens can cause the growth of prostate cancer cells. Antiandrogen drugs, such as abiraterone acetate, may lessen the amount of androgens made by the body. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving abiraterone acetate together with prednisone and veliparib may work better than abiraterone acetate and prednisone alone in treating patients with castration-resistant prostate cancer.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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