metastatic prostatic cancer after castration-resistant progression to docetaxel MedDRA version: 16.0 Level: LLT Classification code 10036947 Term: Prostatic cancer metastatic System Organ Class: 100000004864
Conditions
Interventions
Trade Name: ZYTIGA (Abiraterone Acetate)
Product Name: ZYTIGA (Abiraterone Acetate)
Pharmaceutical Form: Tablet
INN or Proposed INN: ZYTIGA (ABIRATERONE ACETATE)
CAS Number: 154229-18-2
Other descript
Sponsors
Fundacion Publica Andaluza para la Gestion de la Investigacion en Salud de Sevilla
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Patients with prostatic adenocarcinoma histologically or cytologically confirmed without neuroendocrine differentiation or small cell histology. - At least one, but no more than 2, cytotoxic chemotherapy regimens for metastatic prostatic cancer resistant to castration. At least one regimen must have contained docetaxel. If docetaxel chemotherapy was used more than once, be considered as only regime. - Men of 18 or more years old. - Progression criteria according to the recommendations of the Prostate Cancer Working Group. For inclusion progression is considered to have two consecutive elevated PSA measurements over a baseline or radiological evidence of progression in soft tissue or bone (according to modified RECIST criteria) with or without progression based on PSA value - Androgen deprivation present with testosterone levels =65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: - Uncontrolled or severe non-malignant coexisting disease, including active and uncontrolled infection. - Known or suspected allergy to abiraterone acetate or related compounds with this kind of medication. - Inability or unwillingness to swallow tablets. - Other malignancy (except nonmelanoma skin cancer), with a probability ? 30% recurrence in 12 months. - Brain metastases known - Important chronic gastrointestinal disorder with diarrhea as the main symptom (Crohn's disease, ulcerative colitis, malabsorption or ? grade 2 diarrhea of ??any etiology at baseline). - Surgery or local prostatic intervention within 30 days before the first dose. Further, any clinically relevant sequelae of surgery must be resolved before day 1 of cycle 1. - Radiotherapy, chemotherapy or immunotherapy within 30 days before or single fraction of palliative radiotherapy within 14 days prior to the administration of the day 1del cycle 1. - Patients with uncontrolled hypertension (systolic BP> 160 mm Hg or diastolic BP> 95 mmHg), clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the last 6 months, severe or unstable angina, heart failure Class III or IV New York Heart Association heart failure or ejection fraction <50%, active or symptomatic viral hepatitis, chronic liver disease, adrenal or pituitary dysfunction clinically significant. (Patients with hypertension controlled with medication are allowed) - Any acute toxicity from chemotherapy and / or previous radiation therapy has not been resolved to grade ? 1 of the NCI CTCAE (version 4). Allowed alopecia and grade 2 peripheral neuropathy induced by chemotherapy. - Any condition which in the opinion of the investigator would put the patient at significant risk, may confound the results of the study or would significantly interfere with patient participation in the study. - Previous treatment with abiraterone acetate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the pharmacokinetics of abiraterone acetate administered at reduced doses with meals, compared to abiraterone acetate administered conventional-dose fasting .;Secondary Objective: - To describe the tolerance and adverse event profile of abiraterone acetate administered at reduced doses with meals and compare the safety profile of the dose and the conventional dosing regimen. Adverse events were assessed according to Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI), (version 4). - To compare the costs of resources used between the two treatment groups. - To describe efficacy parameters, progression-free survival (PFS) and overall survival (OS), PSAquantification and monitoring, efficacy on pain control and disease progression. - To assess the impact of abiraterone acetate plus prednisone on the quality of life (QOL) related to health. - To evaluate the possible effect of the usual diet in pharmacokinetic parameters in medical abiraterone acetate kinetic points defined.;Primary end point(s): Abiraterone pharmacokinetic parameters: AUC0-t and AUC0-?, Cmax, Tmax with effect from the administration of food. ;Timepoint(s) of evaluation of this end point: At the end or treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - PSA levels at baseline and follow-up until disease progression. - Response rate according to RECIST 1.1 - Pain scales: pain is measured by the BPI-SF scale (Brief Pain Inventory-Short Form, 0-10 points scale where 0 to 3 is no pain, and 4 to 10 indicates the intensity of pain). - Analgesics use: the need for rescue analgesic use associated with pain, analgesic and collect the required DDT. - habitual diet by the patient at home;Timepoint(s) of evaluation of this end point: All visits | — |
Countries
Spain
Contacts
Public ContactUnidad de Investigación Clínica
Unidad de investigación Clínica y ensayos Clínicos
Outcome results
None listed