Safety Study of AP23573 in Patients With Progressive or Recurrent Glioma (8669-023)(COMPLETED)
A Phase I Sequential Ascending Dose Trial of AP23573 in Patients With Progressive or Recurrent Malignant Glioma
調査の概要
詳細な説明
The primary objective of the study is to determine the safety, tolerability, and maximum tolerated dose (MTD) of AP23573 when administered intravenously once daily for five days repeated every two weeks to patients with progressive or recurrent gliomas who have failed standard therapy and who are or are not receiving enzyme-inducing anticonvulsant (EIAC) medications.
The secondary objectives are to: characterize the pharmacokinetic profile of AP23573 when administered daily for five days repeated every two weeks at the indicated dosage levels in patients receiving and not receiving EIAC; describe the progression-free survival at six months; describe changes in proteins affected by mTOR inhibition; describe single timepoint status of proteins affected by mTOR inhibition in tumor tissue surgical specimens after AP23573 dosing; describe the status of key proteins in the mTOR signaling pathway in archival tumor samples, if available; describe health-related quality of life at the start of the trial and prior to study drug infusion and at various timepoints throughout the trial.
Protocol Outline:
This is a Phase I, open-label, non-randomized, sequential dose escalation cohort trial of the safety, tolerability, and MTD of AP23573 when administered intravenously as a 30-minute infusion, once daily for five days, repeated every two weeks, to patients with progressive or recurrent malignant glioma.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02115
- Center For Neuro-Oncology, Dana Farber Cancer Institute
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North Carolina
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Durham、North Carolina、アメリカ、27710
- The Brain Tumor Center at Duke, Duke University Medical Center
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Ohio
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Cleveland、Ohio、アメリカ、44195
- Brain Tumor Institute, The Cleveland Clinic
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Texas
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Houston、Texas、アメリカ、77030
- M.D. Anderson Cancer 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 (Patients must meet each of the following criteria to be eligible for participation in the trial):
- Male or female patients ≥ 18 years of age
- Patients must have a radiographically suspected progressive or recurrent primary malignant glioma (glioblastoma multiforme or gliosarcoma) and must have failed standard therapy. Patients may not have received any systemic therapy for the treatment of this recurrence or relapse
- Patients must be candidates for surgical resection or open biopsy of the tumor
- Patients who have had previous surgical resection(s) are eligible
- Patients must have had minimum prior therapy of radiotherapy and documented progression of disease thereafter
- Patients must have had a tissue proven malignant glioma
- A minimum interval of at least four weeks prior to the first dose of AP23573 must have elapsed for all patients enrolling after either prior surgery or completion of prior external beam radiotherapy for initial primary diagnosis
- A minimum interval of four weeks prior to the first dose of AP23573 must have elapsed since receipt of any investigational therapy or any other chemotherapy
- Patients in the EIAC cohorts must be presently receiving a stable dose of EIAC (e.g., dilantin, phenytoin, etc.) for at least two weeks prior to the first dose of AP23573
- For patients on corticosteroids, the dose must be stable for at least one week prior to the first dose of AP23573
- Patients must be neurologically stable for at least two weeks prior to the first dose of AP23573
- Patients must have an ECOG performance status of 0 or 1
- Patients must either not be of childbearing potential or have agreed to use a medically effective method of contraception
- Patients must have adequate hematologic, renal and liver function as specified in the protocol
- Patients must be able to understand and give written informed consent
Exclusion Criteria (Patients meeting any of the following criteria are ineligible for participation in the trial):
- Women who are pregnant or lactating
- Patients with known or suspected hypersensitivity to either drugs formulated with polysorbate 80 (Tween) or any other excipient contained in the study drug formulation
- Patients with known hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin)
- Patients with significant cardiovascular disease, as specified in the protocol
- Patients with known HIV infection
- Patients with any active infection requiring prescribed intervention
- Patients receiving immunosuppressive agents other than prescribed corticosteroids
- Patients who have had prior therapy with rapamycin, any rapamycin analog or tacrolimus
- Patients with inadequate recovery from any prior surgical procedure or patients having undergone any major surgical procedure within two weeks prior to the first dose of AP23573
- Patients with any other life-threatening illness or organ system dysfunction which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluation of the safety of the study drug
- Patients with a psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies
- Patients with another primary malignancy within the past three years (except for non-melanoma skin cancers and cervical carcinomas in situ)
- Patients with the inability, in the opinion of the Investigator, to comply with the protocol requirements
- Patients are not permitted any chemotherapeutic agents or other antineoplastic agents either during or within four weeks prior to the first dose of AP23573. Additional excluded drugs and treatments are specified in the protocol
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: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)
協力者と研究者
スポンサー
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
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。
AP23573の臨床試験
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Merck Sharp & Dohme LLCUniversity of Colorado, Denver; Memorial Sloan Kettering Cancer Center; H. Lee Moffitt Cancer... と他の協力者完了
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Merck Sharp & Dohme LLCAriad Pharmaceuticals完了肉腫、軟部組織 | 骨肉腫 | 平滑筋肉腫 | 脂肪肉腫 | 転移
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H. Lee Moffitt Cancer Center and Research InstituteMerck Sharp & Dohme LLC完了
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Fox Chase Cancer CenterNational Cancer Institute (NCI)完了
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Merck Sharp & Dohme LLC完了Metastatic or Locally Advanced Cancer
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Merck Sharp & Dohme LLCAriad Pharmaceuticals完了
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Merck Sharp & Dohme LLCAriad Pharmaceuticals完了Metastatic Soft-Tissue Sarcomas | Metastatic Bone Sarcomas
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Merck Sharp & Dohme LLC完了
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Merck Sharp & Dohme LLCAriad Pharmaceuticals完了