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An Open-Label Study to Determine the Short-Term Safety of Continuous Dosing of Abiraterone Acetate and Prednisone in Modified Fasting and Fed States to Subjects With Metastatic Castration-Resistant Prostate Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Neoplasms, Prostate Cancer

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Trial Information

An Open-Label Study to Determine the Short-Term Safety of Continuous Dosing of Abiraterone Acetate and Prednisone in Modified Fasting and Fed States to Subjects With Metastatic Castration-Resistant Prostate Cancer


This is a multicenter, open-label study of 24 (up to a total of 28) men to assess the
short-term safety of oral abiraterone acetate 1 g and oral prednisone 5 mg twice daily
administered in the modified fasted state and after meals of various fat contents. All
patients will take daily abiraterone acetate for the first 7 days in the modified fasted
state (no food for 2 hours before and 1 hour after the dose). In Cohort 1, up to 6 evaluable
patients will take abiraterone acetate daily for 7 days after a standardized low-fat meal
from Cycle 1 Day 8 to Cycle 1 Day 14; or, in Cohort 2, up to 6 evaluable patients will take
abiraterone acetate daily for 7 days after a standardized high-fat meal from Cycle 1 Day 8
to Cycle 1 Day 14. All patients will then continue to take abiraterone acetate daily in the
modified fasted state starting on Cycle 1 Day 15 until disease progression. Toxicity related
to dosing after the low-fat or high-fat meals is defined as Grade 3 or higher AEs of special
interest; or Grade 3 or higher serious adverse events (SAEs) that occur during the food
safety evaluation period. Cohort 2 may be expanded to a total of 18 evaluable patients if
deemed to be safe. Decisions regarding the escalation of cohort or expansion of cohorts will
be made by a study evaluation team. Pharmacokinetic evaluation for each cohort will be
performed on Cycle 1 Days 7 and 14 at predose and multiple timepoints postdose over 24
hours; Cycle 1 Days 8 and 11 at 2 hours following abiraterone acetate dose administration.
Abiraterone acetate, 1 g (four 250-mg tablets) orally (taken by mouth) once daily. Patients
may take abiraterone acetate until progression of clinical disease. Prednisone, 5 mg,
orally, twice a day.


Inclusion Criteria:



- Adenocarcinoma of the prostate

- Metastatic disease documented by bone, computed tomography (CT) or magnetic resonance
imaging (MRI) scan

- Surgical or medical castration with testosterone less than 50 ng/dL (< 2.0 nM)

- Prostate-specific antigen (PSA) or radiographic progression documented by assessments
specified in study protocol

- Platelets >100,000/┬Ál

- Hemoglobin >=9.0 g/dL

- Liver function tests (LFTs): Serum bilirubin < 1.5 x ULN; AST or ALT < 2.5 x ULN;
Eastern Cooperative Oncology Group (ECOG) status score of <=2

Exclusion Criteria:

- Small cell carcinoma of the prostate

- Known brain metastasis, chronic liver disease with elevated LFTs

- Prior cytotoxic chemotherapy for metastatic prostate cancer

- Treatment of prostate cancer within 30 days of Day 1 Cycle 1 with surgery, radiation,
chemotherapy or immunotherapy

- Use of investigational drug within 30 days of Day 1 Cycle 1 or current enrollment in
an investigational drug or device study

- Recent history of ischemic heart disease, Electrocardiogram (ECG) abnormalities or
atrial fibrillation

- Active infection or other medical condition that would make prednisone
(corticosteroid) use contraindicated

- Chronic medical condition requiring a higher dose of corticosteroid than prednisone 5
mg twice daily

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity related to dosing after low-fat or high-fat meals

Outcome Description:

Grade 3 or higher AEs of special interest, including fluid retention/edema, hypokalemia, cardiac disorders, hepatotoxicity (liver function test [LFT] abnormalities), and hypertension; or Grade 3 or higher serious adverse events (SAEs) that occur during the food safety evaluation period.

Outcome Time Frame:

Cycle 1 Day 8 to Cycle 2 Day 1 pre-dose (food safety evaluation period)

Safety Issue:

Yes

Principal Investigator

Janssen-Ortho, Canada Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen-Ortho Inc., Canada

Authority:

Canada: Health Canada

Study ID:

CR018715

NCT ID:

NCT01424930

Start Date:

October 2011

Completion Date:

December 2013

Related Keywords:

  • Prostate Neoplasms
  • Prostate Cancer
  • Metastatic castration-resistant prostate cancer
  • CRPC
  • Abiraterone Acetate
  • Prednisone
  • Food Safety
  • Neoplasms
  • Prostatic Neoplasms

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