A Safety and Tolerability Study of Peginesatide in Anemic Cancer Patients Receiving Cytotoxic Chemotherapy.
2011年11月29日 更新者：Takeda
A Phase 1, Multicenter, Open-Label Dose Escalation Study Evaluating the Safety and Tolerability of Multiple Hematide Injections in Subjects With Refractory Non-Small Cell Lung Cancer, Breast Cancer, or Prostate Cancer Who Are Anemic and Receiving Cytotoxic Chemotherapy
The purpose of this study is to determine the safety and tolerability of peginesatide used to treat anemia in subjects diagnosed with recurrent non-small cell lung cancer, breast cancer or prostate cancer and who also receiving a taxane chemotherapy.
調査の概要
詳細な説明
Currently approved erythropoiesis stimulating agents have been used successfully to increase hemoglobin levels, reduce fatigue and other anemia-related symptoms, improve daily function, and alleviate the need for transfusions of red blood cells in subjects with chronic kidney disease-related anemia or in cancer subjects with chemotherapy-induced anemia.
Peginesatide (hematide) Injection is a parenteral formulation for administration by intravenous or subcutaneous injection that is being developed for the correction of anemia in patients with chronic kidney disease, including patients on dialysis and patients not on dialysis, and for the treatment of patients with anemia due to concomitantly administered chemotherapy.
This is a multicenter, open-label dose escalation study to evaluate the safety, tolerability, and efficacy of multiple doses of peginesatide Injection in subjects with refractory non-small cell lung cancer, breast cancer, or prostate cancer. These subjects must have anemia diagnosed as a result of taxane chemotherapy.
研究の種類
介入
入学 (実際)
2
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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Florida
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Jacksonville、Florida、アメリカ
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Texas
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Corpus Christi、Texas、アメリカ
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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～80年 (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:
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Individuals with one of the following histologically confirmed tumors:
- stage IIIB/IV non-small-cell lung cancer
- metastatic breast cancer
- androgen insensitive prostate cancer and are scheduled to receive at least 4 weeks of chemotherapy, including a taxane.
- Has progression or relapse after treatment with at least one regimen of chemotherapy or hormone therapy.
- Has a hemoglobin value of greater than or equal to 8 and less than 10.5 g/dL within 1 week prior to administration of study drug.
- Has an Eastern Cooperative Oncology Group Performance Status of 0-2.
- Has one ferritin level greater than or equal to 100 ng/mL within 4 weeks prior to study drug administration.
- Has one serum or red cell folate level above the lower limit of normal within 4 weeks prior to study drug administration.
- Has one vitamin B12 level above the lower limit of normal within 4 weeks prior to study drug administration.
- Has one absolute neutrophil count greater than or equal to 1.5 x 109/L within 1 week prior to administration of study drug.
- The subject has a serum creatinine less than or equal to 1.5 mg/dL or a measured creatinine clearance greater than 60 mL/min.
- The subject has one platelet count greater than or equal to 100 x 109/L within 1 week prior to administration of study drug.
- The subject has a Life expectancy greater than 4 months.
- The subject has a body mass index between 18 and 30 kg/m2, inclusive, prior to study drug administration.
- The subject has a negative test result for hepatitis B surface antigen, and hepatitis C virus antibody at Screening.
Exclusion Criteria:
- Has a history of failure to respond to erythropoiesis-stimulating agent treatment.
- Has had treatment with any erythropoiesis-stimulating agent in the past 4 weeks.
- Is known to have antibodies to other erythropoiesis-stimulating agents or history of Pure Red Cell Aplasia.
- Has received Peginesatide in a previous clinical study or as a therapeutic agent.
- Has a history of hypersensitivity or allergies to Peginesatide, other erythropoiesis-stimulating agents or related compounds.
- Has had red blood cell transfusion within 4 weeks prior to study drug administration.
- Has known hemoglobinopathy (eg, homozygous sickle-cell disease, thalassemia of all types, etc).
- Has known hemolytic condition.
- Has known blood loss as a cause of anemia, iron deficiency anemia, or anemia caused by gastrointestinal bleeding.
- Has any previous or planned radiotherapy to more than 30% of active bone marrow.
- Has donated more than 400 mL of blood within the 90 days preceding the beginning of the study.
- Has known intolerance to parenteral iron supplementation.
- Has received IV iron within 1 week of study drug administration.
- Has history of bone marrow or peripheral blood cell transplantation.
- Has central nervous system metastases.
- Has a history of deep venous thrombosis, pulmonary embolism or other thrombotic event (eg, stroke, myocardial infarction, etc.) in the previous 6 months or known history of hypercoagulable disorder.
- Has uncontrolled, or symptomatic inflammatory disease (eg, rheumatoid arthritis, systemic lupus erythematosus, etc).
- Has poorly controlled hypertension per the investigator's judgment within 4 weeks prior to study drug administration (eg, systolic greater than or equal to 170 mm Hg or diastolic greater than or equal to 100 mm Hg on repeat readings).
- Has had a seizure in the 6 months prior to study drug administration.
- Has advanced chronic congestive heart failure - New York Heart Association Class III or IV.
- Has a history or presence of an abnormal electrocardiogram at Screening that, in the investigator's opinion, is clinically significant.
- Has a known history of human immunodeficiency virus.
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as consumption of more than 4 alcoholic drinks per day) within 1 year prior to Baseline.
- Has aspartate aminotransferase or alanine aminotransferase greater than 2.5 times the upper limit of normal (aspartate aminotransferase or alanine aminotransferase greater than 5 times the upper limit of normal if liver metastases are present), active liver disease or jaundice.
- Is currently taking or anticipated to require anticoagulants other than aspirin (eg, coumadin, ticlopidine, etc.).
- Has a bilirubin greater than the upper limit of normal.
- Has pyrexia/fever greater than or equal to 39°C within 48 hours prior to study drug administration.
- Has high likelihood of early withdrawal or interruption of the study (eg, myocardial infarction within the past 3 months, severe or unstable coronary artery disease, stroke, respiratory, autoimmune, neuropsychiatric or neurological abnormalities, or any other clinically significant medical diseases or conditions within the prior 6 months that may, in the investigator's opinion, interfere with assessment or follow-up of the subject).
- Has anticipated elective surgery during the study period.
- Has exposure to any investigational agent within 1 month prior to administration of study drug or planned receipt during the study period.
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：ペギネサチド
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Peginesatide 0.075, 0.1, 0.125, 0.15, 0.175, 0.2, 0.225 or 0.25 mg/kg administered subcutaneously every 3 weeks for a total of at least 2 doses. Subsequent injections given every 3 weeks thereafter regardless of the schedule of subsequent chemotherapy cycles. Following Study Day 43, subjects may continue on Peginesatide treatment, dosing every 3 weeks until 4 weeks after discontinuation of taxane-containing chemotherapy regimen, the occurrence of a dose limiting toxicity, documented disease progression or change in chemotherapy regimen.
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 |
時間枠 |
|---|---|
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Maximum tolerated dose.
時間枠：End of Treatment.
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End of Treatment.
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Proportion of subjects who have 2 consecutive Hgb values of either an increase of ≥1 g/dL or a Hgb ≥11 g/dL in the absence of a red blood cell transfusion.
時間枠：At All Visits for every cycle.
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At All Visits for every cycle.
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Proportion of subjects who have an increase in Hgb of ≥1 g/dL or a Hgb ≥11 g/dL in the absence of a red blood cell transfusion.
時間枠：Days 22 and 43 for every cycle.
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Days 22 and 43 for every cycle.
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Proportion of subjects with 2 consecutive Hgb values increase of ≥1 g/dL or ≥11 g/dL during the Treatment phase absent of red blood cell transfusion within the prior 28 days and without excursion of Hgb values above 12 g/dL for ≥2 consecutive weeks.
時間枠：Within the prior 28 days of every cycle for a minimum of 2 consecutive weeks.
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Within the prior 28 days of every cycle for a minimum of 2 consecutive weeks.
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Proportion of subjects who received at least 1 RBC transfusion.
時間枠：From Day 29 to End of Treatment for every cycle.
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From Day 29 to End of Treatment for every cycle.
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Change from Baseline in Hemoglobin.
時間枠：At Each Visit for every cycle.
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At Each Visit for every cycle.
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Duration of maintaining Hgb values within the range of 10.5 g/dL and 12.0 g/dL.
時間枠：At Each Visit for every cycle.
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At Each Visit for every cycle.
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Pharmacokinetics of Peginesatide (PK Cohort Only).
時間枠：At Each Visit for every cycle.
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At Each Visit for every cycle.
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Adverse events and serious adverse events.
時間枠：At All Visits for every cycle.
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At All Visits for every cycle.
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Physical examination (including weight, vital signs, and oral temperature).
時間枠：At All Visits for every cycle.
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At All Visits for every cycle.
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Clinical Laboratory Tests and Electrocardiograms.
時間枠：At All Visits for every cycle.
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At All Visits for every cycle.
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Electrocardiograms.
時間枠：At Final Visit for every cycle.
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At Final Visit for every cycle.
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Signs and symptoms for thromboembolytic events.
時間枠：At All Visits for every cycle.
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At All Visits for every cycle.
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Proportion of subjects who have incidence of Hgb values >12 g/dL.
時間枠：At All Visits for every cycle.
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At All Visits for every cycle.
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Proportion of subjects who have Hgb increases by more than 1 g/dL in a 2-week period.
時間枠：At All Visits for every cycle.
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At All Visits for every cycle.
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Tumor progression.
時間枠：Every 2 cycles of chemotherapy.
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Every 2 cycles of chemotherapy.
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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。
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1月1日
一次修了 (実際)
2008年6月1日
研究の完了 (実際)
2008年6月1日
試験登録日
最初に提出
2008年2月26日
QC基準を満たした最初の提出物
2008年3月5日
最初の投稿 (見積もり)
2008年3月6日
学習記録の更新
投稿された最後の更新 (見積もり)
2011年12月1日
QC基準を満たした最後の更新が送信されました
2011年11月29日
最終確認日
2011年11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。