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Phase 1/2a Study of DTA-H19 in Advanced Stage Ovarian Cancer

2019年5月21日 更新者：Anchiano Therapeutics Israel Ltd.

Phase 1/2a, Dose-Escalation, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Intraperitoneal Administration of DTA-H19 in Subjects With Advanced Stage Ovarian Cancer

This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of DTA-H19 administered intraperitoneally (IP) in subjects with advanced stage ovarian cancer, or primary peritoneal carcinoma

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This is a Phase 1/2a, open label, dose escalation, repeat dose study in 11 subjects with recurrent, platinum resistant advanced stage ovarian cancer or primary peritoneal carcinoma designed to determine the tolerability, safety, quality of life, PK, and preliminary efficacy of DTA-H19 administered intraperitoneally(IP).

Primary Objective: The primary objectives of this study are:

  • To determine the maximum tolerated dose (MTD) of IP DTA-H19; and,
  • To identify any dose limiting toxicities (DLTs).

Secondary Objectives: Secondary objectives of this study are:

  • To determine quality of life of subjects with advanced ovarian cancer, primary peritoneal carcinoma treated with IP DTA-H19;
  • To determine the the reduction in malignant ascites as measured by Ultrasound and change in frequency of parecenteses necessary.
  • To determine the overall survival distribution.

研究の種類

介入

入学 (実際)

14

段階

  • フェーズ2
  • フェーズ 1

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。

研究場所

  • イスラエル
      • Holon、イスラエル
        • The Edith Wolfson Medical Center
      • Jerusalem、イスラエル
        • Hadassah University Hospital
      • Kfar Saba、イスラエル
        • Meir Hospital
      • Tel Hashomer、イスラエル
        • Sheba Medical Center

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

女性

説明

Inclusion Criteria:

  • Provide written informed consent and be at least 18 years of age.
  • Have histopathologically documented epithelial ovarian carcinoma or primary peritoneal carcinoma with evidence of ascites.
  • Have either a) platinum-refractory disease (i.e. persistent disease following completion of platinum-based primary chemotherapy) and have failed at least primary platinum-based chemotherapy; or b) platinum-resistant recurrent disease and have failed at least one regimen of second line chemotherapy.
  • Be able to tolerate placement of IP catheter.
  • Be at least 2 weeks from last treatment to allow recovery from prior toxicity but in the judgment of the investigator with sufficient time to ensure that the effects of prior treatments will not confound safety evaluations.
  • Have a Karnofsky performance status score of ≥ 70%.
  • Not be of child-bearing potential.
  • Have a life expectancy of ≥ 3 months.
  • Have serum creatinine < 2.0 mg/dL, total bilirubin less than the institution's 3x upper limit of normal (ULN); AST and ALT <= 2.5 x ULN,total albumin ≥ 2.5 g/dL, PT, PTT, and PT/INR within normal limits, absolute neutrophil count (ANC) > 1,500 x 103 cells/mL, platelets ≥ 100,000/mL, and hemoglobin ≥ 10 mg/dL.
  • Have a biopsy specimen or an ascites fluid that is positive for H19 expression.
  • Have screening procedures completed within 6-weeks before starting treatment.
  • No significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina or congestive heart failure.
  • - No plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of cancer while on this protocol.

Exclusion Criteria:

  • Have evidence of extra abdominal disease with the exception of isolated small nodules (e.g., liver or pulmonary nodules) that are not causing symptoms.
  • Have known brain metastases.
  • Have known HIV infection.
  • Have known active viral or bacterial infections.
  • Have presence of any psychological, familiar, sociological, or geographical condition potentially hampering compliance with the study protocol or follow up schedule.
  • Have a medical condition contraindicated for laparotomy, laparoscopy, or surgery.
  • Have significant bowel involvement denoted by persistent grade 3 vomiting (≥6 episodes in 24 hrs; IV fluids, or total parenteral nutrition (TPN) indicated ≥24 hrs) after removal of ascites, inability to tolerate oral diet or medications, requirement for total parenteral nutrition, or recent (past six weeks) episode of bowel obstruction.
  • Have a history of coagulopathy.

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：BC-819
BC-819 60, 120 and 240 mg IP administration
生物学的：BC-819

Cohort #1: 60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.

Cohort #2: 120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.

Cohort #3: 240 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.

他の名前：
  • DTA-H19

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
Number of Participants With Dose-Limiting Toxicities
時間枠：8 weeks
A dose limiting toxicity (DLT) was defined as any grade 3 or greater non-hematologic AE by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). If one subject in a cohort experienced a DLT, then three additional subjects had to be enrolled to that cohort unless a second subject in that cohort experiences a DLT. The next lower dose was to be considered the MTD.
8 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Overall Survival in ITT Population
時間枠：17.5 months
Overall survival, defined as the time from the start of treatment until the subject died, was estimated by Kaplan Meier curves.
17.5 months
Solid Tumor Response
時間枠：6 weeks

If measurable disease was present, then the response of each marker lesion was evaluated separately and rated for response according to RECIST criteria for solid tumors.

Complete Response: Disappearance of the target lesion. Partial Response: At least a 30% decrease in the longest diameter of the target lesion.

Stable Disease: No sufficient shrinkage to qualify for partial response, or sufficient increase to qualify for progressive disease.

Progressive Disease: At least a 20% increase in the longest diameter of the target lesion.
6 weeks
Systemic BC-819 Pharmacokinetics (PK) by Treatment - T1/2 (Hours)
時間枠：Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.
Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
Systemic BC-819 Pharmacokinetics (PK) - Maximum Observed Plasma Concentration (Cmax)
時間枠：Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.
Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
Systemic BC-819 Pharmacokinetics (PK) by Treatment - Tmax (Hours)
時間枠：Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.
Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
Systemic BC-819 Pharmacokinetics (PK) by Treatment - AUClast
時間枠：Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.
Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
Systemic BC-819 Pharmacokinetics (PK) by Treatment - AUCinf
時間枠：Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
Blood was collected at the indicated time points, then analyzed with a quantitative polymerase chain reaction (Q-PCR) method to quantitate the amount of plasmid present.
Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion
Overall Survival in PP
時間枠：17.5 months
Overall survival, defined as the time from the start of treatment until the subject died, was estimated by Kaplan Meier curves.
17.5 months

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。

スポンサー

Anchiano Therapeutics Israel Ltd.

捜査官

  • 主任研究者：Tally Levy, M.D.、The Edith Wolfson Medical Center
  • 主任研究者：David Edelman, MD、Hadassah University Hospital
  • 主任研究者：Ami Fishman, MD、Meir Medical Center
  • 主任研究者：Eitan Rami, MD.、Rabin Medical Center
  • 主任研究者：Ofer Lavie, M.D.、Carmel Medical Center
  • 主任研究者：Ronnie Shapira-Frommer, MD、Sheba Medical Center

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

2009年6月1日

一次修了 (実際)

2012年2月1日

研究の完了 (実際)

2012年2月1日

試験登録日

最初に提出

2009年1月18日

QC基準を満たした最初の提出物

2009年1月18日

最初の投稿 (見積もり)

2009年1月21日

学習記録の更新

投稿された最後の更新 (実際)

2019年6月13日

QC基準を満たした最後の更新が送信されました

2019年5月21日

最終確認日

2019年5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

  • BC-08-01

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