MDACC Study Summary 2009-0168

Study Summary
No. 2009-0168:.......Prostate......Christopher Logothetis......Genitourinary Medical Oncology

Study Summary Title



Study Summary Number:	2009-0168

Study Title:	A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients with Metastatic Castration-Resistant Prostate Cancer

Physician

New Patient Referral



Name:	Christopher Logothetis	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Genitourinary Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2830 Contact us about clinical trials

General Information



Disease Group:	Prostate	Supported By:	Cougar Biotechnology, Inc.

Phase of Study:	Phase III	Return Visit:	Patients will return every 2 weeks for the first 3 cycles and every 4 weeks thereafter.

Treatment Agents:	Abiraterone Acetate (CB7630) Placebo Prednisone	Home Care:	Patients will be responsible for self-administration of both abiraterone acetate/placebo and prednisone.

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	The goal of this clinical research study is to compare how well 2 study treatments may be able to help control metastatic prostate cancer. Prednisone plus abiraterone acetate will be compared against prednisone alone. The safety of abiraterone acetate will also be studied.

Study Objectives / Outcomes

Primary Objective(s)

To compare the clinical benefit of abiraterone acetate plus prednisone versus placebo plus prednisone in patients with chemotherapy-naīve castration-resistant prostate cancer (CRPC) who are asymptomatic or mildly symptomatic.

Secondary Objective(s)
The secondary objectives of this study are:

To establish additional clinically relevant improvements in prostate cancer patients treated with abiraterone acetate in comparison to placebo
To characterize the safety profile of abiraterone acetate in this patient population
To characterize the pharmacokinetics of abiraterone acetate when administered concurrently with prednisone

Study Status Information



Study Activation / Registration Date:	07/08/2009

IRB Review and Approval Date:	05/18/2009

Study Type:	Phase Iii

Recruitment Status:	Closed

Projected Accrual:	1000

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Willing and able to provide written informed consent

2) Written Authorization for Use and Release of Health and Research Study Information (US sites only) or Data Protection Consent (European sites only) has been obtained

3) Male aged 18 years and above

4) Histologically or cytologically confirmed adenocarcinoma of the prostate

5) Metastatic disease documented by positive bone scan or metastatic lesions other than liver or visceral metastasis on CT, MRI. If lymph node metastasis is the only evidence of metastasis, it must be >/= 2 cm in diameter

6) Prostate cancer progression documented by PSA according to PCWG2 or radiographic progression according to modified RECIST criteria.

7) Asymptomatic or mildly symptomatic from prostate cancer. A score of 0-1 on Brief Pain Inventory Short Form (BPI-SF) Question # 3 (worst pain in last 24 hours) will be considered asymptomatic, and a score of 2-3 will be considered mildly symptomatic.

8) Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nM). If the patient is being treated with luteinizing hormone-releasing hormone (LHRH) agonists (patient who have not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to Cycle 1 Day 1 and must be continued throughout the study.

9) Previous anti-androgen therapy and progression after withdrawal. Patients who received combined androgen blockade with an anti-androgen must have shown PSA progression after discontinuing the anti-androgen prior to enrollment (>/= 4 weeks since last flutamide, >/= 6 weeks since last bicalutamide or nilutamide).

10) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

11) Hemoglobin >/= 10.0 g/dL independent of transfusion

12) Platelet count >/= 100,000/microL

13) Serum albumin >/= 3.5 g/dL

14) Serum creatinine < 1.5 x ULN or a calculated creatinine clearance >/= 60 mL/min

15) Serum potassium >/= 3.5 mmol/L

16) Liver function: i.) Serum bilirubin < 1.5 x ULN (except for patients with documented Gilbert's disease) ii.) AST or ALT < 2.5 x ULN

17) Able to swallow the study drug whole as a tablet

18) Life expectancy of at least 6 months

19) Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration.

Exclusion Criteria:

1) Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated

2) Any chronic medical condition requiring a higher dose of corticosteroid than 5mg prednisone/prednisolone bid.

3) Pathological finding consistent with small cell carcinoma of the prostate

4) Liver or visceral organ metastasis

5) Known brain metastasis

6) Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1

7) Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC

8) Radiation therapy for treatment of the primary tumor within 6 weeks of Cycle 1, Day 1

9) Radiation or radionuclide therapy for treatment of metastatic CRPC

10) Previously treated with ketoconazole for prostate cancer for greater than 7 days

11) Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of Cycle 1, Day 1

12) Prior flutamide (Eulexin) treatment within 4 weeks of Cycle 1, Day 1 (patients whose PSA did not decline for three or more months in response to antiandrogen given as a second line or later intervention will require only a two week washout prior to Cycle 1, Day 1)

13) Bicalutamide (Casodex), nilutamide (Nilandron) within 6 weeks of Cycle 1 Day 1 (patients whose PSA did not decline for three or more months in response to antiandrogen given as a second line or later intervention will require only a two week washout prior to Cycle 1, Day 1)

14) Uncontrolled hypertension (systolic BP </= 140 mmHg or diastolic BP >/= 90 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment

15) Active or symptomatic viral hepatitis or chronic liver disease

16) History of pituitary or adrenal dysfunction

17) Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline

18) Atrial Fibrillation, or other cardiac arrhythmia requiring therapy

19) Other malignancy, except non-melanoma skin cancer, with a >/= 30% probability of recurrence within 24 months

20) Administration of an investigational therapeutic within 30 days of Cycle 1, Day 1

21) Any condition which, in the opinion of the investigator, would preclude participation in this trial.

Links

Registration Number: NCT00887198
Study Information on Clinical Trials Registry (clinicaltrials.gov)