Phase 2
Completed N=159
Abiraterone Acetate and Prednisone With or Without Veliparib in Treating Patients With Metastatic Castration-Resistant Prostate Cancer
Castration-Resistant Prostate Carcinoma · Recurrent Prostate Carcinoma · Stage IV Prostate Cancer AJCC v7
Source: ClinicalTrials.gov NCT01576172 ↗
Enrolled (actual)
159
Serious AEs
20.9%
Results posted
Nov 2020
Primary outcomePrimary: Confirmed Prostate-specific Antigen (PSA) Response Rate — 46; 55 Participants — p=0.27
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmed Prostate-specific Antigen (PSA) Response Rate |
46; 55 | 0.27 |
| SECONDARY Rates of PSA Decline |
-41.1; -52.9 | 0.70 |
| SECONDARY Objective Response Rates in Patients With Measurable Disease. |
18; 24 | 0.51 |
| SECONDARY Progression-free Survival (PFS) |
10.1; 11.0 | 0.99 |
| SECONDARY Grade 4 or 5 Adverse Events |
1; 3 | 0.62 |
Eligibility Criteria
Inclusion Criteria
- Have a histologic or cytologic diagnosis of prostate cancer
- Have progressive metastatic castration-resistant prostate cancer, on androgen-deprivation therapy, based on at least one of the following criteria:
- PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1-week interval with a minimum PSA of 2 ng/mL
- Progression of bidimensionally measurable soft tissue (nodal metastasis) assessed within one month prior to registration by a computed tomography (CT) scan or magnetic resonance imaging (MRI) of the abdomen and pelvis
- Progression of bone disease (evaluable disease) (new bone lesion[s]) by bone scan
- Agree to undergo a biopsy of at least 1 metastatic site for gene-fusion status analysis; adequate archival metastatic tissue can be used if available in lieu of a biopsy; patients will only be eligible for protocol therapy if the biopsy has tumor and the tissue is evaluable for ETS fusion status
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Have testosterone = 3,000/ul
- Obtained within 14 days prior to registration: Absolute neutrophil count (ANC) >= 1,500/ul
- Obtained within 14 days prior to registration: Platelet count >= 100,000/ul
- Obtained within 14 days prior to registration: Serum creatinine = = 50 mg/ml/hr/1.73 m^2 body surface area (BSA)
- Obtained within 14 days prior to registration: Potassium >= 3.5 mmol/L
- Obtained within 14 days prior to registration: Bilirubin within the institutional limits of normal
- Obtained within 14 days prior to registration: Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) = = 10.0 g/dL hemoglobin (Hb) with no blood transfusion in the past 28 days
- Men must agree to use effective contraception during treatment and for at least 1 week after the last administration of therapy
- Patients must be able to take oral medication without crushing, dissolving, or chewing tablets
- Patients may have received prior radiation therapy or surgery; however, at least 21 days must have elapsed since completion of radiation therapy or surgery and patient must have recovered from all side effects at the time of registration
- Ability to understand and the willingness to sign a written informed-consent document that is approved by the local institutional review board
Exclusion Criteria
- Patients may not be receiving any other investigational agents; any prior investigational products must be stopped at least 14 days (2-week washout) prior to registration
- Patients who have had chemotherapy, radiotherapy or oral antifungal agents (ketoconazole, itraconazole, fluconazole) within 3 weeks prior to entering the study or those who have not recovered (e.g. back to baseline or grade 1) from adverse events due to agents administered more than 3 weeks earlier
- There is a potential drug interaction when abiraterone is concomitantly used with a cytochrome P450 family 2, subfamily D, polypeptide 6 (CYP2D6) substrate narrow therapeutic index (e.g., thioridazine, dextromethorphan), or strong cytochrome P450 family 3, subfamily A, polypeptide 4 [CYP3A4] inhibitors (e.g., atazanavir, erythromycin, indinavir, itraconazole, Ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole) or strong inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine); caution should be used when patients are on one of these drugs
- Patients with history of active seizures are not eligible
- Patients with a history of pituitary or adrenal dysfunction, active or symptomatic viral hepatitis, or chronic liver disease are not eligible
- Patients with known brain metastases should be excluded from this clinical trial
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ABT-888 or abiraterone
- Patients may continue
Data sourced from ClinicalTrials.gov (NCT01576172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.