Abiraterone Post Ketoconazole for Prostate Cancer

University of California San Francisco (UCSF)

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: Abiraterone acetate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01199146

CC# 085514

Details and patient eligibility

About

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

Enrollment

42 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.
1. Ketoconazole must have been administered for >28 days
2. 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 < 50 ng/dL
Progressive disease after androgen deprivation: PSA evidence for progressive prostate cancer consists of a PSA level of at least 2 ng/ml which has risen on at least 2 successive occasions, at least 2 weeks apart
Patients who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of antiandrogen
ECOG Performance Status 0-1
Age >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 < 4 weeks prior to enrollment
Prior chemotherapy for castration resistant prostate cancer. Patients who have received chemotherapy for early stage prostate cancer (e.g. as part of a neoadjuvant or adjuvant trial) or for other malignancies are eligible provided that >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