A Phase I Study of ECO-4601 in Patients With Advanced Cancer
2008年7月10日 更新者:Thallion Pharmaceuticals
A Phase I, Dose Finding, Pharmacokinetic, and Safety Study of Continuous IV Infusion of ECO-4601 in Patients With Advanced Cancer Including an Extension Portion to Obtain Safety Data at the Highest Tolerable Dose
The purpose of this study was to determine the maximum tolerated dose (MTD) and the recommended dose for future studies of ECO-4601 administered as a continuous IV infusion for 14 days with 7 days recovery (21 day cycle) in patients with histologically confirmed solid tumors (high grade glioma, colorectal, lung, breast, ovarian, pancreatic and prostate).
This study was also designed to determine the clinical pharmacokinetic profile, safety of multiple cycles of administration, and document the antitumor activity of ECO-4601.
調査の概要
研究の種類
介入
入学 (実際)
26
段階
- 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
-
-
Quebec
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Greenfield Park、Quebec、カナダ、J4V 2H1
- Hopital Charles LeMoyne
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Montreal、Quebec、カナダ、H3T 1E2
- Sir Mortimer B. Davis Jewish General Hospital
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-
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
全て
説明
Inclusion Criteria:
- Informed about the study and consent to participate in the study
- Clinically or radiologically documented advanced solid malignancy for which no standard therapy is available, or which has failed standard therapy
- Patients with the following solid tumors: high grade glioma, colorectal, prostate, pancreatic, lung, ovarian and breast carcinoma
- Age ≥ 18 years of age
- ECOG ≤ 2
- Laboratory hematology and biochemistry protocol test result abnormalities ≤ Grade 1, graded using NCI CTCAE version 3.0
- Patients with no chemotherapy during the 4 weeks preceding patients' first dose of ECO-4601 (day 1, cycle 1)
- No other anticancer treatment during the study
- Patients can be receiving stable or decreasing dose of steroids within 2 weeks prior to patient's signature of the informed consent
- Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre
Previous Therapy
- Hormonal therapy: Patients may have had prior hormonal therapy provided it is discontinued upon ICF signature
- Radiation: Patients may have had prior radiation therapy. Patients must have recovered from the acute toxic effects of radiotherapy
- Previous surgery: Previous surgery is permitted provided that at least 2 weeks have elapsed between major surgery (non-biopsy) and ICF signature
Exclusion Criteria:
- Patients with brain metastases
- Unlikely to comply with protocol or difficulty to understand the purpose of the study
- Life expectancy < 12 weeks
- Clinically significant co-morbid disease, e.g. renal failure, ischemic vascular disease, uncontrolled seizure, dementia
- Any patient with a potentially curable malignancy who has not yet received appropriate standard therapies
- Anti seizure drugs known inducers of cytochrome P450
- Documented HIV, active hepatitis B or C infections
- Patients with active or uncontrolled infections or with serious illnesses or medical conditions, which would not permit the patient to be managed according to protocol
- Pregnant or lactating women; both men and women enrolled on study should be using adequate birth control measures throughout the course of the study. Women of childbearing potential must have a negative serum or urine pregnancy test documented within 14 days prior to registration and at study start
- Inability or refusal to practice contraception during therapy of ECO-4601, unless patient is surgically sterile or woman is postmenopausal for at least 2 years
- Patients who have been treated with any investigational drug within 4 weeks of patient's signature of informed consent form, or who are receiving concurrent treatment with other experimental drugs or anti cancer therapy
- Patients in whom a proper central line cannot be established
- Concomitant therapy with therapeutic coumadin; patients can be transferred to low molecular weight heparin
- Patients on low molecular weight heparin for < 2 weeks prior to ICF signature
- Polysorbate 80 being a major constituent of ECO-4601 and known to cause hypotension, patients with uncontrolled hypotension will be excluded
- Known hypersensitivity to farnesylated dibenzodiazepinone or any of the formulation components
Concomitant Therapy Permitted:
- Patients may receive ongoing supportive and palliative care (eg: pain control) as clinically indicated throughout the study.
- Patients can be treated with corticosteroids if medically needed
- Usage of low molecular weight heparin is allowed
- Anti seizure products are permitted provided they are not inducers of cytochrome P450.
Concomitant Therapy Not Permitted:
- Other anticancer treatment
- Other investigational therapy
- Concomitant therapy with coumadin
- Cytochrome enzyme inducing anti epileptics
- G-CSF, GM-CSF and other growth factors may not be used as a substitute for a scheduled dose reduction; however they may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated at the discretion of the investigator. Use of erythropoietin is allowed if treatment has been initiated for ≥ 2 months. Use of growth factors must be documented on case report forms.
- Hormonal therapy
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:非ランダム化
- 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:ECO-4601
|
Continuous IV infusion for 14 days with 7 days recovery (21 day cycle)
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 |
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Safety/tolerability of ECO-4601
|
Determination of MTD of ECO-4601
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Determination of recommended dose for future studies of ECO-4601
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二次結果の測定
結果測定 |
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Pharmacokinetics of ECO-4601
|
Safety of multiple cycles of administration of ECO-4601
|
Documentation of ECO-4601 antitumor activity as per RECIST criteria
|
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
捜査官
- 主任研究者:Petr Kavan, MD, Ph.D.、Sir Mortimer B. Davis - Jewish General Hospital
- 主任研究者:Benoît Samson, MD、Hopital Charles LeMoyne
- スタディチェア:Gerald Batist, MD、Sir Mortimer B. Davis - Jewish General Hospital
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
2006年2月1日
一次修了 (実際)
2007年8月1日
研究の完了 (実際)
2007年8月1日
試験登録日
最初に提出
2006年6月15日
QC基準を満たした最初の提出物
2006年6月16日
最初の投稿 (見積もり)
2006年6月20日
学習記録の更新
投稿された最後の更新 (見積もり)
2008年7月15日
QC基準を満たした最後の更新が送信されました
2008年7月10日
最終確認日
2008年7月1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。
ECO-4601の臨床試験
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Foundation for Innovative New Diagnostics, Switzerland募集