薬理ゲノミクス IND EXEMPT SNP 臨床研究 - アレクチニブと一塩基多型 (Drugs-SNPs)
非小細胞肺がん患者における一塩基多型とアレクチニブの反応および毒性との関係を調査します。
Explore the relationship between drug target ALK gene single nucleotide polymorphisms and ALECENSA - Alectinib therapeutic-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.
Explore the relationship between drug target CYP4503A4 gene single nucleotide polymorphisms and ALECENSA - Alectinib side-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.
調査の概要
状態
詳細な説明
The usual approach group, diagnosed metastatic ALK-positive NSCLC, 300 Sequential Assignment group separated NSCLC patients currently used the Chemotherapy on ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily, it will try to look for the relationship between the Alectinib therapeutic efficacy and the ALK SNP Genotyping, and the relationship between the Alectinib therapeutic safety and the CYP4503A SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.
The study approach group, diagnosed metastatic ALK-positive NSCLC, 300 Sequential Assignment group separated NSCLC patients currently used the Chemotherapy on ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily, it will try to look for the relationship between the Alectinib therapeutic efficacy and the ALK SNP Genotyping, and the relationship between the Alectinib therapeutic safety and the CYP4503A4 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.
- Detect drug target whole gene precision sequence of everyone patient for all 600 recruited Sequential Assignment NSCLC patients.
- Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited Sequential Assignment NSCLC patients.
- Calculate drug target gene SNPs in all 600 recruited Sequential Assignment NSCLC patients.
- Correlate everyone patient drug target gene SNP to everyone patient drug efficacy.
- Correlate everyone patient drug target gene SNP to everyone patient drug safety.
- Mutually compare the usual approach group SNPs (300 Sequential Assignment group separated NSCLC patients) with the study approach group SNPs (300 Sequential Assignment group separated NSCLC patients).
- Confirm the relationship between drug target gene SNPs and drug efficacy.
- Confirm the relationship between drug target gene SNPs and drug safety.
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
-
-
Florida
-
Doral、Florida、アメリカ、33172
- Omnicure Clinical Research
-
-
Maryland
-
Rockville、Maryland、アメリカ、20853
- Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
-
Select 600 patients with Metastatic ALK-Positive Non-Small Cell Lung Cancer (NSCLC) as follows:
- Took ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily more than 90 days
- Had no further NSCLC metastatic or growth in more than previous 90 days
-
Dosage Duration at least 90 days
-
The usual approach group - Recruit 300 Sequential Assignment group separated NSCLC patients currently used the Chemotherapy NDC...01 on ALECENSA capsule 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, like as the usual approach group.
-
The study approach group - Recruit 300 Sequential Assignment group separated NSCLC patients currently used the Chemotherapy NDC...86 on ALECENSA capsule 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, like as the study approach group.
Inclusion Criteria:
- 1. Metastatic ALK-Positive Non-Small Cell Lung Cancer (NSCLC) as follows:
- Took ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily more than 90 days
- Had no further NSCLC metastatic or growth in more than previous 90 days
- 2. Suitable for enough blood-drawing
- 3. Sequential Assignment
- 4. Measurable disease
- 5. Adequate organ functions
- 6. Adequate performance status
- 7. Age 24-64 years old
- 8. Sign an informed consent form
- 9. Receive blood-drawing
Exclusion Criteria:
- 1. Pneumonectomy
- 2. Treatment with other anti-cancer therapies and cannot be stopped currently
- 3. Pregnancy
- 4. Breast-feeding
- 5. The patients with other serious intercurrent illness or infectious diseases
- 6. Have more than one different kind of cancer at the same time
- 7. Serious Allergy to Drugs
- 8. Serious Bleed Tendency
- 9. Serious Risks or Serious Adverse Events of the drug product
- 10. The prohibition of drug products
- 11. Have no therapeutic effects
- 12. Follow up to the most current label
研究計画
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：ヘルスサービス研究
- 割り当て：なし
- 介入モデル：順次割り当て
- 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：ALECENSA - alectinib hydrochloride capsule
|
他の名前：
|
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 |
|---|---|---|
|
Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated
時間枠：Up to 12 weeks
|
|
Up to 12 weeks
|
|
Measure and Report Alectinib Drug Targets' SNP Genotypes which are risk-associated
時間枠：Up to 12 weeks
|
|
Up to 12 weeks
|
協力者と研究者
協力者
捜査官
- スタディチェア：Han Xu, MD/PhD/FAPCR、Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
- スタディディレクター：Han Xu, MD/PhD/FAPCR、Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
- 主任研究者：Han Xu, MD/PhD/FAPCR、Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
- 主任研究者：Anneyd Avalos, M.D.、Omnicure Clinical Research - Site 1
- 主任研究者：Felipe Gascon-Rondon, M.D.、Omnicure Clinical Research - Site 2
- 主任研究者：Jeffrey Levy, M.D.、Omnicure Clinical Research - Site 3
- 主任研究者：Ellie Soheili, M.D.、Omnicure Clinical Research - Site 4
- 主任研究者：Marc E. Csete, M.D.、Omnicure Clinical Research - Site 5
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IND 168453 SNP
- FWA00015357 (レジストリ識別子：HHS, Human Protections Administrator)
- IORG0007849 (レジストリ識別子：HHS, IORG)
- IRB00009424 (レジストリ識別子：HHS, IRB)
- NPI - 1831468511 (レジストリ識別子：HHS, Health Care Provider Individual)
- NPI - 1023387701 (レジストリ識別子：HHS, Health Care Provider Organization)
- IND 168453 (レジストリ識別子：FDA, IND)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。