Phase 2
Completed N=42
Abiraterone Post Ketoconazole for Prostate Cancer
Source: ClinicalTrials.gov NCT01199146 ↗Enrolled (actual)
42
Serious AEs
11.9%
Results posted
Jan 2018
Primary outcomePrimary: Preliminary Evidence of Efficacy of Abiraterone Acetate — 20 Participants
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Preliminary Evidence of Efficacy of Abiraterone Acetate |
20 | — |
| SECONDARY Time To Progression (TTP) |
16 | — |
| SECONDARY Proportion of Patients With PSA Decline of > 50% |
19 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed adenocarcinoma of the prostate
- Prior therapy with ketoconazole for castration resistant prostate cancer. Patients should demonstrate evidence of progression (see below definitions) on ketoconazole or evidence of grades 3/4 toxicities on ketoconazole.
- Ketoconazole must have been administered for >28 days
- At least 27 days must elapse since last ketoconazole dose and first dose of abiraterone acetate
- No prior therapy with chemotherapy for metastatic prostate cancer
- Metastatic disease based on a positive bone scan or objective imaging on CT scan
- Ongoing gonadal androgen deprivation therapy with LHRH analogues or orchiectomy. Patients, who have not had an orchiectomy, must be maintained on effective LHRH analogue therapy for the duration of the trial
- Testosterone 18 years and able to comply with protocol requirements
- Serum Creatinine ≤1.5 x ULN
- Serum potassium >3.5mmol/L
- Bilirubin ≤1.5x ULN
- AST and ALT ≤2.5 x ULN
- Life expectancy of >12 weeks
Exclusion Criteria
- Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart) any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES), or any systemic corticosteroid within 4 weeks prior to first dose of study drug
- Therapy with supplements or complementary medicines/botanicals within 4 weeks of first dose of study drug, except for any combination of the following; conventional multivitamin supplements, Selenium, Lycopene and Soy supplements
- Prior radiation therapy completed 1 year has passed since the administration of the last chemotherapy dose.
- Hemoglobin ≤9.0 g/dL
- Any "currently active" second malignancy, other than non-melanoma skin cancer Patients are not considered to have a "currently active" malignancy, if they have completed therapy and are considered by their physician to be at least less than 30% risk of relapse over next 3 months
- Blood pressure that is not controlled despite >2 oral agents (SBP >160 and DBP >90 on three or more readings within the screening period)
- Serum K+ <3.5 mmoL/L on more than one reading within the screening period
- NYHA Class II, NYHA Class III or IV Congestive Heart Failure
- Myocardial infarction within the 6 months prior to the first dose of study drug
- Serious intercurrent infections or nonmalignant medical illnesses that are uncontrolled
- Concurrent therapy with drugs that are metabolized as substrates of CYP1A2, CYP2D6, or CYP2C19 and are considered by the investigators to pose a risk for drug to drug interactions
Data sourced from ClinicalTrials.gov (NCT01199146). 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.