進行性または転移性乳がん患者を対象としたカペシタビンによる PCS6422 の第 2 相試験
進行性または転移性乳がん患者を対象としたカペシタビンと PCS6422 の第 2 相非盲検試験
This is an adaptive Phase 2, open-label, randomized, multi-center study evaluating up to 2 regimens of PCS6422 with capecitabine (Cap) vs. standard dose of Cap alone in patients with advanced or metastatic breast cancer. The goal of the study is to assess the efficacy and safety of PCS6422 + Cap as a treatment option for patients with advanced or metastatic breast cancer who are not eligible for anthracycline- or taxane-containing therapies, or other available therapies, including PD-1 or PARP inhibitors.
調査の概要
詳細な説明
This is an adaptive Phase 2, open-label, randomized, multi-center study evaluating up to 2 regimens of PCS6422 with Cap vs. standard dose of Cap alone in patients with advanced or metastatic breast cancer who are not eligible for anthracycline- or taxane-containing therapies, or other available therapies, including PD-1 or PARP inhibitors. The goal of the study is to assess the efficacy and safety of PCS6422 + Cap as a treatment option for patients with advanced or metastatic breast cancer who have been treated with chemotherapy in the metastatic setting.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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California
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Los Angeles、California、アメリカ、90067
- Valkyrie Clinical Trials
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Oxnard、California、アメリカ、93030
- FOMAT Medical Research
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Florida
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Miami、Florida、アメリカ、33165
- AP Medical Research
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Tampa、Florida、アメリカ、33612
- Moffitt Cancer Center
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Indiana
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Dyer、Indiana、アメリカ、46311
- Northwest Cancer Center
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Maryland
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Baltimore、Maryland、アメリカ、21201
- University of Maryland Medical Center (UMMC)
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New Jersey
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New Brunswick、New Jersey、アメリカ、08901
- Rutgers Cancer Institute of New Jersey
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New York
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Westbury、New York、アメリカ、11590
- Clinical Research Alliance
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Ohio
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Canton、Ohio、アメリカ、44718
- Gabrail Cancer Center Research
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Tennessee
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Nashville、Tennessee、アメリカ、37203
- SCRI Oncology Partners
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Texas
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Austin、Texas、アメリカ、78731
- Texas Oncology PA (Austin)
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San Antonio、Texas、アメリカ、78240
- Texas Oncology PA (San Antonio)
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-
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
Inclusion Criteria:
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Aged ≥18 years at Screening
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Diagnosis of histologically confirmed breast cancer that is unresectable. The following subsets of breast cancer are included:
- Patients with triple-negative breast cancer, advanced or metastatic
- Patients with hormone receptor (HR) positive, ER positive, HER2 negative advanced or metastatic breast cancer
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Has measurable disease in accordance with RECIST 1.1 obtained by imaging within 28 days prior to C1D1
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Other therapies are not indicated (eg, resistant or intolerant to taxanes and/or an anthracycline-containing regimen) for treatment of advanced or metastatic breast cancer
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Has a life expectance of at least 24 weeks
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Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1 at screening
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Has adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days before C1D1 (Note: labs will also be repeated pre-dose on C1D1 to confirm eligibility): a. Hemoglobin ≥9 g/dL (≥90 g/L) b. Adequate renal function by estimated glomerular filtration rate (eGFR) defined as a creatinine clearance >50 mL/min (>0.84 mL/s) (Cockcroft-Gault equation) and normalized to body surface area c. Peripheral absolute neutrophil count (ANC) of ≥1.5×109/L d. Platelet count of ≥100×109/L without growth factor/transfusion e. Total bilirubin <1.5× upper limit of normal (ULN); or ≤3×ULN if the patient has Gilbert's disease f. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5×ULN, with liver metastasis <5×ULN g. International normalized ratio (INR) <1.5 and prothrombin time (PT) ≤1.5×ULN, unless both of the following conditions are met: i. Patient is receiving anticoagulant therapy, and ii. PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulant h. Activated partial thromboplastin time (aPTT) ≤1.5×ULN, unless both of the following conditions are met: i. Patient is receiving anticoagulant therapy, and ii. PT or PTT is within therapeutic range of intended use of anticoagulants
Exclusion Criteria:
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Received any line of treatment for advanced or metastatic breast cancer within 21 days or 5 half-lives (whichever is longer) prior to randomization
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Currently receiving any hormone replacement therapy, unless discontinued within 21 days prior to randomization
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Received IV 5-FU or oral 5-FU analog in the 4 weeks prior to C1D1
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Received DPD inhibitor within 4 weeks prior to C1D1
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Has homozygous or compound heterozygous DPYD variants that result in complete or near-complete absence of DPD activity
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Cardiac:
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Has history or presence of clinically significant abnormal 12-lead electrocardiogram (ECG) results, in the Medical Monitor or Investigator's opinion
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Has prolonged QTc (with Fridericia's correction) of >480 msec performed at Screening
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Has a history of prolonged QTc interval, ventricular tachycardia/fibrillation or significant ventricular arrhythmia, or Torsades de Pointes, or a history of ventricular ablation for arrhythmia
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Has congenital long QT syndrome or a family history of long QT syndrome
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Has other clinically significant cardiac disease including, but not limited to, myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery ≤12 months prior to randomization, congestive heart failure
- Class II per the New York Heart Association, or history of myocarditis
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Is pregnant or breastfeeding
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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：PCS6422 40 mg + Capecitabine 300 mg
Fixed single dose of PCS6422 administered with Capecitabine 150 mg BID over 7 days |
PCS6422 is an experimental drug that, when combined with capecitabine, may make the immune response more active against cancer.
他の名前：
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実験的：PCS6422 40 mg + Capecitabine 450 mg or 150 mg
Fixed single dose of PCS6422 administered with Capecitabine 225 mg or 75 mg BID over 7 days |
PCS6422 is an experimental drug that, when combined with capecitabine, may make the immune response more active against cancer.
他の名前：
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アクティブコンパレータ：Capecitabine 2000 mg/m2
Standard capecitabine dose at 1000 mg/m2 BID |
Commercially available capecitabine is a commonly used oral fluoropyrimidine.
他の名前：
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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 |
|---|---|---|
|
Evaluation of Objective Response Rate (ORR)
時間枠：Up to 24 weeks post End of Treatment (EoT)
|
The proportion of patients who achieved a confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) |
Up to 24 weeks post End of Treatment (EoT)
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Number of patients with adverse events (AEs)
時間枠：During treatment, an average of 8 months
|
Frequency, duration, and severity of AEs across treatment groups |
During treatment, an average of 8 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Evaluation of Disease Control Rate (DCR)
時間枠：Up to 24 weeks post End of Treatment (EoT)
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The proportion of patients with objective evidence of CR or PR or stable disease (SD) according to RECIST 1.1 |
Up to 24 weeks post End of Treatment (EoT)
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Evaluation of Duration of Response (DOR)
時間枠：Up to 24 weeks post End of Treatment (EoT)
|
The proportion of patients with DOR |
Up to 24 weeks post End of Treatment (EoT)
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Evaluation of Time to Response (TTR)
時間枠：Every 12 weeks during treatment
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The number of patients with days to response |
Every 12 weeks during treatment
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Evaluation of Progression Free Survival (PFS)
時間枠：Up to 24 weeks post End of Treatment (EoT)
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Patients with number of days of progression free response |
Up to 24 weeks post End of Treatment (EoT)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Mridula George, MD、Rutgers University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- PCS6422-BC-01
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
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