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History of Changes for Study: NCT01217697
Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer
Latest version (submitted March 23, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 7, 2010 None (earliest Version on record)
2 October 11, 2010 Interventions, Study Description and Study Status
3 October 21, 2010 Interventions, Study Status and Study Description
4 November 12, 2010 Study Status
5 December 3, 2010 Recruitment Status, Study Status and Contacts/Locations
6 December 10, 2010 Study Status
7 December 16, 2010 Contacts/Locations and Study Status
8 December 23, 2010 Contacts/Locations and Study Status
9 December 30, 2010 Contacts/Locations, Interventions, Study Description and Study Status
10 January 7, 2011 Interventions, Study Status, Contacts/Locations and Study Description
11 January 13, 2011 Contacts/Locations and Study Status
12 January 20, 2011 Contacts/Locations and Study Status
13 January 27, 2011 Contacts/Locations and Study Status
14 February 3, 2011 Contacts/Locations and Study Status
15 March 3, 2011 Contacts/Locations and Study Status
16 March 24, 2011 Contacts/Locations, Interventions, Conditions, Study Description and Study Status
17 April 1, 2011 Contacts/Locations, Study Status and Study Design
18 April 26, 2011 Contacts/Locations and Study Status
19 May 26, 2011 Contacts/Locations and Study Status
20 June 23, 2011 Contacts/Locations and Study Status
21 June 30, 2011 Contacts/Locations and Study Status
22 July 14, 2011 Contacts/Locations and Study Status
23 November 23, 2011 Recruitment Status, Contacts/Locations, Study Design, Study Status, Interventions, Outcome Measures and Oversight
24 December 5, 2011 Study Status and Contacts/Locations
25 February 27, 2012 Study Status and Contacts/Locations
26 March 28, 2012 Study Status and Contacts/Locations
27 April 26, 2012 Study Status and Study Identification
28 May 24, 2012 Study Status
29 June 14, 2012 Study Status
30 July 6, 2012 Study Status and Contacts/Locations
31 July 27, 2012 Contacts/Locations and Study Status
32 August 17, 2012 Study Status and Contacts/Locations
33 September 7, 2012 Study Status
34 September 29, 2012 Contacts/Locations and Study Status
35 October 19, 2012 Study Status and Contacts/Locations
36 November 9, 2012 Sponsor/Collaborators, Study Status and Contacts/Locations
37 November 30, 2012 Contacts/Locations and Study Status
38 December 21, 2012 Study Status and Contacts/Locations
39 January 11, 2013 Recruitment Status, Study Design, Study Status, Contacts/Locations, Interventions and Outcome Measures
40 February 1, 2013 Study Status and Contacts/Locations
41 February 22, 2013 Contacts/Locations, Study Status and Oversight
42 March 15, 2013 Study Status and Contacts/Locations
43 April 5, 2013 Study Status and Contacts/Locations
44 April 26, 2013 Contacts/Locations and Study Status
45 May 28, 2013 Contacts/Locations and Study Status
46 June 18, 2013 Contacts/Locations and Study Status
47 July 9, 2013 Study Status and Contacts/Locations
48 July 31, 2013 Contacts/Locations and Study Status
49 January 29, 2014 Contacts/Locations, Study Status and Oversight
50 February 20, 2014 Contacts/Locations and Study Status
51 March 13, 2014 Contacts/Locations and Study Status
52 April 3, 2014 Study Status and Contacts/Locations
53 April 24, 2014 Contacts/Locations and Study Status
54 May 15, 2014 Study Status and Contacts/Locations
55 June 5, 2014 Study Status and Contacts/Locations
56 June 26, 2014 Contacts/Locations and Study Status
57 July 17, 2014 Contacts/Locations and Study Status
58 August 7, 2014 Contacts/Locations and Study Status
59 September 24, 2014 Study Status
60 October 15, 2014 Study Status and Contacts/Locations
61 November 5, 2014 Contacts/Locations and Study Status
62 November 26, 2014 Contacts/Locations and Study Status
63 December 17, 2014 Study Status and Contacts/Locations
64 January 19, 2015 Recruitment Status, Contacts/Locations, Study Status and Study Design
65 March 27, 2015 Study Status
66 May 18, 2015 Study Status
67 July 27, 2015 Study Status
68 October 2, 2015 Study Status and Eligibility
69 February 3, 2016 Recruitment Status and Study Status
70 September 28, 2016 Contacts/Locations, Interventions, Study Status and References
71 December 27, 2016 Recruitment Status, Study Status, Study Design, Interventions, Oversight, Contacts/Locations and Outcome Measures
72 January 23, 2017 Study Status and Study Identification
73 March 23, 2017 Study Status
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Study NCT01217697
Submitted Date:  October 7, 2010 (v1)

Open or close this module Study Identification
Unique Protocol ID: CR017479
Brief Title: Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer
Official Title: An Open Label Study of Abiraterone Acetate in Subjects With Metastatic Castration-Resistant Prostate Cancer Who Have Progressed After Taxane-Based Chemotherapy
Secondary IDs: 212082PCR3001
Open or close this module Study Status
Record Verification: October 2010
Overall Status: Not yet recruiting
Study Start:
Primary Completion: July 2013 [Anticipated]
Study Completion: May 2015 [Anticipated]
First Submitted: October 7, 2010
First Submitted that
Met QC Criteria:
October 7, 2010
First Posted: October 8, 2010 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 7, 2010
Last Update Posted: October 8, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: The purpose of this study is to collect additional safety information on abiraterone acetate administered with prednisone to patients with metastatic castration-resistant prostate cancer (CRPC).
Detailed Description: This is a study to collect information on adverse events (side effects) that occur during treatment with albiraterone acetate in patients with metastatic castration-resistant prostate cancer (CRPC). To participate in this study patients must have failed 1 or 2 chemotherapy regimens (1 of which contained a taxene such as docetaxel), reside in an area where albiraterone acetate is not yet available through local healthcare providers, and not be eligible for enrollment in any other ongoing clinical reseach study of abiraterone acetate. CPRC is progressive form of prostate cancer where the cancer cells become resistant to hormonal therapies that are designed to block the release or uptake of testosterone and the cancer cells metastasize (ie, spread to other parts of the body). Abiraterone acetate (referred to as abiraterone) is a drug currently under development for use in treating men with CPRC. Patients will be treated with abiraterone and prednisone daily until progression of clinical disease (ie, includes signs of clinical disease progression and/or clinical disease progression confirmed by radiographic and prostate-specific antigen [PSA] test results). Other reasons for discontinuation of treatment may include adverse events reported, initiation of other anticancer therapies, or the patient's inability to comply with dosing instructions. Patients will be followed for 30 days after the discontinuation of treatment with abiraterone acetate. Patients will take four 250-mg tablets of abiraterone orally at least 1 hour before a meal or 2 hours after a meal any time up to 10 pm every day. Patients will also take 5 mg of oral prednisone, twice daily. Each treatment cycle consists of 28 days and patients will take abiraterone continually on a daily basis until disease progression is observed at which time abiraterone will be discontinued and the dose of prednisone reduced if clinically indicated.
Open or close this module Conditions
Conditions: Prostate Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Keywords: Metastatic Castration-Resistant Prostate Cancer (CPRC)
Abiraterone Acetate
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment:
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: 001
Abiraterone Acetate Four 250-mg tablets once daily every day until disease progression. Patients will also take one 5-mg tablet of prednisone twice daily everday until the time of disease progression at which time the dose will be reduced if clinically indicated.
Drug: Abiraterone Acetate
Four 250-mg tablets once daily every day until disease progression. Patients will also take one 5-mg tablet of prednisone, twice daily everday until the time of disease progression at which time the dose will be reduced if clinically indicated.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. The number and type of adverse events reported by the investigator or the patient.
[ Time Frame: From the time of signing the informed consent to the time of the End-of-Study Visit (ie, 30 days after discontinuation of study drug). ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Confirmed prostate cancer
  • Prostate cancer progression after previous chemotherapy as assessed by the investigator
  • Received at least 1 but not more than 2 chemotherapy regimens for metastatic CRPC (at least one regimen must have contained a taxane such as docetaxel)
  • Serum testosterone of less than 50ng/dL (less than 2.0 nM)
  • Eastern Cooperative Oncology Group (ECOG) performance status of <=2 (ie, patients who do not have symptoms of prostate cancer and who are fully active, patients who have symptoms but are able to perform light work, or patients who are able to get around and are capable of taking care of themselves but are unable to carry out any work activities)

Exclusion Criteria:

  • Serious or uncontrolled co-existent non-malignant disease (including active and uncontrolled infection)
  • Active or symptomatic viral hepatitis or chronic liver disease or any abnormal liver function assessed by liver function tests
  • Clinically significant heart disease as assessed by the Investigator or uncontrolled hypertension (systolic blood pressure >=160 mmHg or diastolic blood pressure >=95 mmHg)
  • History of gastrointestinal disorders that may interfere with the absorption of the study drug or history of pituitary or adrenal dysfunction
  • Known brain metastasis (ie, spread of cancer to the brain)
Open or close this module Contacts/Locations
Central Contact Person: This study is not yet recruiting patients. Please check back for future recruiting sites, or email
Email: info1@veritasmedicine.com
Study Officials: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Study Director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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