A Study of PF-04217903 in Patients With Advanced Cancer
2012年6月15日 更新者：Pfizer
Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Study of PF-4217903 in Patients With Advanced Cancer
PF-04217903 may work in cancer by blocking the cell growth, migration and invasion of tumor cells.
PF-04217903 is a new member in a class of drugs called c-Met/hepatocyte growth factor receptor tyrosine kinase inhibitors.
This research study is the first time PF-04217903 will be given to patients.
PF-04217903 is taken by mouth daily.
調査の概要
詳細な説明
The study was prematurely discontinued due to a strategic development decision by Pfizer on 10FEB2012.
The decision to terminate was not based on any safety concerns.
研究の種類
介入
入学 (実際)
16
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
-
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Colorado
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Aurora、Colorado、アメリカ、80045
- Pfizer Investigational Site
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Illinois
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Chicago、Illinois、アメリカ、60637
- Pfizer Investigational Site
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Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Pfizer Investigational Site
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Boston、Massachusetts、アメリカ、02115
- Pfizer Investigational Site
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Boston、Massachusetts、アメリカ、02215
- Pfizer Investigational Site
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Michigan
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Detroit、Michigan、アメリカ、48201
- Pfizer Investigational Site
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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:
- Advanced solid tumors, histologically proven at diagnosis which is refractory to standard of care or for whom no standard of care therapy is available
- Adequate blood cell counts, normal kidney function, and performance status of 0 or 1
Exclusion Criteria:
- Major surgery, radiation therapy or anti-cancer therapy within 2 weeks of starting study treatment
- Prior stem cell transplant
- Active or unstable cardiac disease or heart attack within 12 months of starting study treatment
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 |
|---|---|
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実験的：1
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Escalating doses of PF-04217903 will be administered orally on a continuous dosing schedule.
Doses to be evaluated will range from 50 mg BID to 1000 mg BID.
A cycle is considered to be 21 days
|
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 |
|---|---|---|
|
Maximum Tolerated Dose (MTD)
時間枠：Baseline up to 21 days after the start of each increased treatment dose
|
MTD: dose level at which 1 of 6 participants experienced dose-limiting toxicity (DLT) after 21 days of treatment (Cycle 1).
DLT: grade (Gr) 2 elevated creatinine, acute renal failure, Gr 3 thrombocytopenia with bleeding, hypertension (if unmanageable),Gr >=3 non-hematological non-disease-related (NDR) toxicities (except alopecia,Gr 3/4 hypophosphatemia, hyperuricemia), Gr 3/4 nausea, vomiting, diarrhea, Gr 4 neutropenia, thrombocytopenia lasting for >=7 days, febrile neutropenia, neutropenic infection, inability to deliver 80 percent of planned dose during Cycle 1 due to NDR toxicities.
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Baseline up to 21 days after the start of each increased treatment dose
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Recommended Phase 2 Dose (RP2D)
時間枠：Baseline up to 21 days after the start of each increased treatment dose
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Baseline up to 21 days after the start of each increased treatment dose
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|
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Number of Participants With Dose-Limiting Toxicities (DLTs)
時間枠：Baseline up to 21 days after the start of each increased treatment dose
|
DLT includes Gr 2 elevated creatinine and acute renal failure, Gr 3 thrombocytopenia with bleeding, hypertension (if unmanageable), Gr >= 3 non-hematological non-disease-related (NDR) toxicities (except alopecia, Gr 3/4 hypophosphatemia, hyperuricemia), Gr 3/4 nausea, vomiting, diarrhea, Gr 4 neutropenia, thrombocytopenia lasting for >= 7 days, febrile neutropenia, neutropenic infection, inability to deliver at least 80 percent of planned dose during Cycle 1 due to NDR adverse events.
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Baseline up to 21 days after the start of each increased treatment dose
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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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Maximum Observed Plasma Concentration (Cmax) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)
時間枠：0 (pre-dose), 1, 2, 4, 6, 8 and 12 hours (hrs) (just prior to evening dosing) post dose on Cycle (C) 1 Day (D) 1 and C2 D1
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0 (pre-dose), 1, 2, 4, 6, 8 and 12 hours (hrs) (just prior to evening dosing) post dose on Cycle (C) 1 Day (D) 1 and C2 D1
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Minimum Observed Plasma Trough Concentration (Cmin) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)
時間枠：0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1
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Participants did not receive 200 mg twice a day dose of study treatment for this specific measure.
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0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)
時間枠：0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1
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0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1
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Pre-dose Plasma Concentration (Ctrough) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)
時間枠：0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1
|
Participants did not receive 200 mg twice a day dose of study treatment for this specific measure.
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0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1
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Area Under the Plasma Concentration Time-curve From Zero to the Last Measured Concentration [AUC(0-last)] for PF-04217903 and PF-04217903 Metabolite (PF-04328029)
時間枠：0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1
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Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
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0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1
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Area Under the Curve From Time Zero to End of Dosing Interval [AUC(0-tau)] for PF-04217903 and PF-04217903 Metabolite (PF-04328029)
時間枠：0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1
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Area under the concentration-time profile from time zero to time tau (dosing interval), where tau is equal to 12 hours.
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0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1
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Accumulation Ratio (Rac) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)
時間枠：0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1
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Rac is obtained from AUCtau (Cycle 2 Day 1) divided by AUCtau (Cycle 1 Day 1).
Participants did not receive 200 mg twice a day dose of study treatment for this specific measure.
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0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1
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Metabolite to Parent Ratio Area Under the Curve From Time Zero to End of Dosing Interval (MRAUCtau)
時間枠：0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1
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Molar ratio of metabolite to parent area under the plasma concentration time-curve from zero (pre-dose) to end of dosing interval (MRAUCtau).
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0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1
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Apparent Oral Clearance (CL/F) for PF-04217903
時間枠：0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1
|
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Participants did not receive 200 mg twice a day dose of study treatment for this specific measure.
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0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1
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Change From Baseline in Tumor Proliferation Using F-Fluoro-3'-Deoxy-3'-L-Fluorothymidine Positron Emission Tomography (FLT-PET) Imaging at Day 1 of Cycle 2
時間枠：Cycle 2 Day 1
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F-fluoro-3'-deoxy-3'-L-fluorothymidine positron emission tomography (FLT-PET) imaging was used to assess the tumor proliferation in RP2D cohorts.
Results of the FLT-PET were scored according to the methods developed by the American College of Radiology Imaging Network (ACRIN).
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Cycle 2 Day 1
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Percentage of Participants With Objective Response (OR)
時間枠：Baseline until disease progression up to C2 D1
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Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).
Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response.
CR was defined as disappearance of all lesions (target and/or non target).
PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
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Baseline until disease progression up to C2 D1
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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
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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
2008年8月1日
一次修了 (実際)
2011年6月1日
研究の完了 (実際)
2011年6月1日
試験登録日
最初に提出
2008年6月25日
QC基準を満たした最初の提出物
2008年6月25日
最初の投稿 (見積もり)
2008年6月27日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年6月25日
QC基準を満たした最後の更新が送信されました
2012年6月15日
最終確認日
2012年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- B0331002
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