Safety Study of BLZ-100 in Adult Subjects With Sarcoma Undergoing Surgery
A Phase 1 Study of BLZ-100 Administered by Intravenous Injection in Subjects With Soft Tissue Sarcoma Undergoing Surgery
調査の概要
詳細な説明
Subjects who provide voluntary written informed consent will be screened for eligibility. Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to participate.
This is a two part study:
Part 1 - Dose Finding: Subjects will be required to arrive at the phase 1 unit for dosing 2-3 days prior to the planned surgical excision. Two dose levels of BLZ-100 (3 mg and 12 mg) will be evaluated in a total of 6 subjects with a 2-3 day post-dose imaging interval (also defined as the Intermediate Imaging interval).
Part 2 - Imaging Interval Assessment: The BLZ-100 dose to be evaluated in Part 2 will be determined by the Protocol Steering Committee following completion of Part 1. In Part 2, up to 15 additional subjects will be randomized into one of three imaging interval groups (up to 6 subjects per group): Early Imaging (within 1 day post BLZ-100 dose), Intermediate Imaging (2-3 days post BLZ-100 dose), and Late Imaging (4-7 days post BLZ-100 dose). Subjects will be required to arrive at the phase 1 unit for dosing between 1 and 7 days prior to planned surgical excision, depending on which imaging interval they are randomized to.
Following dosing, all subjects will be monitored for safety.
研究の種類
段階
- フェーズ 1
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、90048
- Cedars-Sinai Medical Center
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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:
- Male of female subject aged 18-75 years
- Diagnosis of soft tissue sarcoma, with scheduled surgical removal for treatment for the disease and completion of chemotherapy or radiation within 4 weeks of BLZ-100 administration
- Able to provide written informed consent
- If of child-bearing potential, agree to continued use of two reliable methods of contraceptive from study entry (time of informed consent) through 30 days after BLZ-100 administration
- Available for all study visits and able to comply with all study requirements
Exclusion Criteria:
- Clinically-suspected and/or pathologically-confirmed sarcoma of the bone (e.g. osteosarcoma, Ewing's sarcoma with bony involvement, chondrosarcoma, Kaposi's sarcoma, extraosseous primitive neuroectodermal tumor [PNET])
- Evidence of metastatic disease
- Female who is lactating/breastfeeding
- Female with a positive pregnancy test or who is planning to become pregnant during the duration of the study
- Karnofsky Performance Status of <60%
Any of the following laboratory abnormalities at Screening:
- Neutrophil count <1.5 x 10^9/L
- Platelets <75 x 10^9/L
- Hemoglobin <10 g/dL (may be determined following transfusion)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3x upper limit of normal (ULN)
- Total bilirubin >1.5x upper limit of reference range (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction)
- Internal Normalized Ratio (INR) >1.5
- Creatinine >1.5x ULN
- Calculated estimated glomerular filtration rate (eGFR) ≤60 mL/min
- Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)
- QTc prolongation >450 msec
- History of hypersensitivity or allergic reactions requiring corticosteroids, epinephrine, and/or hospitalization
- Uncontrolled asthma or asthma requiring oral corticosteroids
- Known or suspected sensitivity to imaging agents that may be used in clinical assessment of this study
- Known or suspected sensitivity to indocyanine green (ICG)
- Unstable angina, myocardial infarction, known or suspected transient ischemic events, or stroke within 24 weeks of start of Screening
- Uncontrolled hypertension
- Initiation of new photosensitizing drugs within 30 days of Screening
- Use of any ongoing medications, which might generate fluorescence or, according to the medication label, might generate a photochemical reaction. These include haematoporphyrin derivatives and purified fractions, Photofrin®, and the precursors of protoporphyrin IX (5-Aminolevulinic acid) used in Gliolan or Hexvix
- Receipt of an investigational drug or device within 30 days of enrollment
- Prior administration of BLZ-100
- Any concurrent condition, including psychological and social situations, which, in the opinion of the investigator, would adversely impact the subject or the interpretation of the study data
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
- 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 |
|---|---|
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実験的：BLZ-100
All participants in the study will receive the investigational drug product BLZ-100. In part 1 of the study, two dose levels of BLZ-100 will be evaluated (3 mg and 12 mg) in 6 subjects, with a 2-3 post-dose imaging window. In part 2 of the study up to 15 additional subjects will be randomized to one of three imaging interval groups (up to 6 subjects/interval): Early Imaging (within 1 day post-BLZ-100 dose), Intermediate Imaging (2 - 3 days post- BLZ-100 dose), and Late Imaging (4 - 7 days post- BLZ-100 dose). |
All subjects enrolled in the study will receive doses of BLZ-100, an investigational drug for imaging tumors. Three different imaging windows will be investigated during the study: Early Imaging (imaging occurs within 1 day post-BLZ-100 dose); Intermediate Imaging (imaging occurs within 2-3 days post-BLZ-100 dose); Late Imaging (imaging occurs 4-7 post-BLZ-100 dose) All subjects in Part 1 of the study will be imaged in the Intermediate Imaging group. Subjects in Part 2 of the study will be randomized into one of the three imaging groups.
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 |
|---|---|---|
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有害事象のある参加者の数
時間枠：治験薬投与7日後
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安全性は、身体検査とバイタルサインおよび実験室の安全パラメータの測定によって評価されます。
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治験薬投与7日後
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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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Change of concentration of BLZ-100 in the blood
時間枠：Prior to dosing and at 1 minute, 5 minutes, 15 minutes, 30 minutes, 60 minutes and 120 minutes after end of injection, and pre-surgery and 24 hours post-surgery
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BLZ-100 levels in blood will be analyzed by chemical means and these data will be used to calculate pharmacokinetic parameters.
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Prior to dosing and at 1 minute, 5 minutes, 15 minutes, 30 minutes, 60 minutes and 120 minutes after end of injection, and pre-surgery and 24 hours post-surgery
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Fluorescence signal from areas of tumor and non-tumor
時間枠：1 day post-dose, 2-3 days post-dose, or 3-7 days post-dose
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Fluorescent signal in sections of excised tumor and adjacent normal tissue will be measured using an infrared imaging system.
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1 day post-dose, 2-3 days post-dose, or 3-7 days post-dose
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Ideal combination of dose and imaging interval
時間枠：1 day post-dose, 2-3 days post-dose, 3-7 days post-dose
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Fluorescent signal will be evaluated in sections of excised tumor and adjacent normal tissue to determine which imaging interval provides the optimal images.
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1 day post-dose, 2-3 days post-dose, 3-7 days post-dose
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Charles Forscher, MD、Cedars-Sinai Medical Center
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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。
BLZ-100の臨床試験
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Blaze Bioscience Inc.Pacific Pediatric Neuro-Oncology Consortium完了
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University of WashingtonBlaze Bioscience Inc.終了しましたステージ III の口唇および口腔がん AJCC v8 | 口腔扁平上皮がん | ステージ I 口唇および口腔がん AJCC v8 | ステージ II 口唇および口腔がん AJCC v8 | ステージ IVA 口唇および口腔がん AJCC v8アメリカ
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National Heart, Lung, and Blood Institute (NHLBI)完了心筋梗塞 | 心筋虚血 | 心臓疾患 | 心血管疾患 | 冠動脈疾患