Clinical trial NCT01217697: 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
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Prostate Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Keywords: Metastatic Castration-Resistant Prostate Cancer (CRPC)
Abiraterone Acetate
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2010-10-08
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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 abiraterone 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 taxane such as docetaxel), reside in an area where abiraterone acetate is not yet available through local healthcare providers, and not be eligible for enrollment in any other ongoing clinical research study of abiraterone acetate. CRPC 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 CRPC. 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.

Eligibility 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
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country: Mexico
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country: Mexico
city: Mexico, D.F.
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country: Mexico
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country: Mexico
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country: Mexico
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country: Mexico
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country: New Zealand
city: Grafton
country: New Zealand
city: Hamilton
country: New Zealand
city: Palmerston North
country: New Zealand
city: Wellington
country: New Zealand
city: Gdansk
country: Poland
city: Lodz
country: Poland
city: Opole
country: Poland
city: Otwock
country: Poland
city: Wroclaw
country: Poland
city: Ponce
country: Puerto Rico
city: San Juan
country: Puerto Rico
city: Brasov
country: Romania
city: Bucuresti
country: Romania
city: Cluj-Napoca
country: Romania
city: Iasi
country: Romania
city: Barnaul
country: Russian Federation
city: Ekaterinburg
country: Russian Federation
city: Kazan
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Obninsk
country: Russian Federation
city: Omsk
country: Russian Federation
city: Pyatigorsk
country: Russian Federation
city: Rostov-On-Don
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St-Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Ufa
country: Russian Federation
city: Singapore
country: Singapore
city: Badajoz
country: Spain
city: Barakaldo Vizcaya
country: Spain
city: Barcelona
country: Spain
city: Cordoba
country: Spain
city: Hospitalet. Barcelona
country: Spain
city: La Coruña
country: Spain
city: Madrid
country: Spain
city: Palma De Mallorca
country: Spain
city: Salamanca
country: Spain
city: Santa Cruz De Tenerife
country: Spain
city: Sevilla
country: Spain
city: Toledo
country: Spain
city: Valencia
country: Spain
city: Kaohsiung County
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Taoyuan
country: Taiwan
city: Bangkok
country: Thailand
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Sternberg CN, Castellano D, Daugaard G, Geczi L, Hotte SJ, Mainwaring PN, Saad F, Souza C, Tay MH, Garrido JM, Galli L, Londhe A, De Porre P, Goon B, Lee E, McGowan T, Naini V, Todd MB, Molina A, George DJ; Abiraterone Global EAP Investigators. Abiraterone acetate for patients with metastatic castration-resistant prostate cancer progressing after chemotherapy: final analysis of a multicentre, open-label, early-access protocol trial. Lancet Oncol. 2014 Oct;15(11):1263-8. doi: 10.1016/S1470-2045(14)70417-6. Epub 2014 Sep 18.