A Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer
2019年2月28日 更新者：Janssen Research & Development, LLC
A Phase 2 Open Label Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy.
The purpose of this study is to assess the safety and efficacy in Korea or Taiwan of oral abiraterone acetate and oral prednisolone in men with metastatic-castration resistant prostate cancer (mCRPC) and with disease progression following treatment with a docetaxel-containing chemotherapy.
調査の概要
詳細な説明
This is an open-label (all people know the identity of the intervention), multicenter, single arm (only one treatment group) study to evaluate the efficacy and safety of abiraterone acetate in patients with mCRPC.
The study will be divided into screening phase (up to 28 days before enrollment), treatment phase including treatment cycles (each cycle of treatment will be 28 days), and follow-up phase.
Approximately 80 patients will be enrolled into this study.
Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram and vital signs as well as pharmacokinetic (what the body does to drug) assessments will be conducted in this study.
Patients will continue to receive abiraterone acetate plus prednisolone until disease progression or occurrence of unacceptable toxicity.
研究の種類
介入
入学 (実際)
82
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
男
説明
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the prostate (stage IV)
- Has documented Prostate Specific Antigen (PSA) progression according to protocol-specific prostate specific antigen working group (PSAWG) eligibility criteria
- Has undergone prior chemotherapy for prostate cancer with regimen(s) containing Docetaxel
- Has an ongoing androgen deprivation with serum testosterone less than 50 ng/dL
- Has not received radiotherapy, chemotherapy, or immunotherapy at least 30 days prior to the treatment
- Eastern Cooperative Oncology Group Performance Status less than or equal to 2
Exclusion Criteria:
- Active or uncontrolled autoimmune disease that may require corticosteroid therapy
- Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
- Uncontrolled hypertension
- Hemoglobin less than or equal to 9.0 g/dL independent of transfusion
- Has abnormal liver function tests
- Surgery or local prostatic intervention within 30 days of the first dose
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Abiraterone actetate and Prednisolone
|
Type=exact number, unit=mg, number=250, form=tablet, route=oral.
Patients will receive 4 tablets of abiraterone acetate at least 1 hour before a meal or 2 hours after a meal any time up to 10 pm every day.
他の名前：
Type=exact number, unit=mg, number=5, form=tablet, route=oral.
Patients will receive 1 tablet of prednisolone twice daily.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Participants With Prostate-specific Antigen (PSA) Response
時間枠：Baseline, Month 4
|
The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.
|
Baseline, Month 4
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall Survival
時間枠：Up to 3 Years
|
Overall survival is defined as the time interval from the date of the first dose to the date of death due to any reason.
|
Up to 3 Years
|
|
Time to PSA Progression
時間枠：Up to 28 Months
|
Time to PSA progression was measured as the time interval from the date of the first dose to the date of PSA progression as defined in the protocol-specific PSAWG criteria.
For participants who have achieved a greater than or equal to (>=) 50% decrease from the baseline PSA, assessment of time to disease progression is when the PSA has increased 50% above the nadir and at a minimum of 5 nanogram/mililiter (ng/mL).
For participants without a PSA decrease of this magnitude or without a decrease, the time for progression is calculated at the time a 25% increase from baseline PSA has been achieved.
|
Up to 28 Months
|
|
Percentage of Participants With Objective Radiographic Response
時間枠：Up to 3 Years
|
Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0.
The CR is disappearance of all lesions.
The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
|
Up to 3 Years
|
|
Serum Testosterone
時間枠：Baseline and End-of-Treatment Visit (up to approximately 3 years)
|
Median serum testosterone concentration was reported at baseline and End-of-Treatment visit.
|
Baseline and End-of-Treatment Visit (up to approximately 3 years)
|
|
Dehydroepiandrosterone Sulfate (DHEA-S)
時間枠：Baseline and End-of-Treatment Visit (up to approximately 3 years)
|
Median DHEA-S concentration was reported at baseline and End-of-Treatment visit.
|
Baseline and End-of-Treatment Visit (up to approximately 3 years)
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：Up to 3 Years
|
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
Up to 3 Years
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2011年8月30日
一次修了 (実際)
2013年1月24日
研究の完了 (実際)
2018年3月6日
試験登録日
最初に提出
2012年9月12日
QC基準を満たした最初の提出物
2012年9月14日
最初の投稿 (見積もり)
2012年9月17日
学習記録の更新
投稿された最後の更新 (実際)
2019年3月15日
QC基準を満たした最後の更新が送信されました
2019年2月28日
最終確認日
2019年2月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CR100009
- 212082PCR2007 (その他の識別子：Janssen Research & Development, LLC)
医薬品およびデバイス情報、研究文書
米国FDA規制機器製品の研究
いいえ
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