Phase I Study for Safety and Efficacy of P276-00 in Subjects With Myeloma
An Open Label, Multicenter Phase I Study To Evaluate Safety and Efficacy of P276-00 in Subjects With Relapsed and Relapsed/Refractory Multiple Myeloma
This research study is a Phase I/II clinical trial. It is done to determine the best doses that the investigational drug (P276-00) can be used safely. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more information about it such as; the safest dose to use, the side effects it may cause and if it is effective for treating relapsed/refractory multiple myeloma.
A majority of multiple myeloma patients overexpress a protein that plays a role in regulating the body's cell cycle called Cyclin D1. The study drug P276-00 is a Cyclin D1 inhibitor under investigation in the treatment of solid tumors. The researchers therefore believe that Cyclin D1 should be studied as a therapeutic target in myeloma. In this research study, we are looking for the highest dose of P276-00 that can be given safely and to see how well it works
調査の概要
詳細な説明
研究の種類
入学 (予想される)
段階
- フェーズ 1
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:
1. Subject previously diagnosed with multiple myeloma based either on the standard or the International Myeloma Foundation (IMF) diagnostic criteria as defined in Appendix A 2. Subjects must have relapsed or relapsed/refractory disease after at least 2 prior lines of therapy as defined in Appendix D 3. Monoclonal protein in the serum of ³ 1 gm/dL or monoclonal light chain in the urine protein electrophoresis of ³ 200 mg/ 24 hours, or measurable light chains by free light chain assay of ³ 10 mg/dL, or measurable plasmacytoma 4. Age ≥ 18 years at the time of signing the informed consent form 5. ECOG performance status < 2 6. Life expectancy > 3 months 7. Subjects must have the following laboratory parameters:
- Hemoglobin > 8.0 gm/dL
- Absolute neutrophil count (ANC) ≥1000 cells/mm3
- Platelets count ≥ 50,000/mm3
- Serum SGOT/AST <3.0 x institutional upper limits of normal (ULN)
- Serum SGPT/ALT <3.0 x institutional upper limits of normal (ULN)
- Serum creatinine <2.5mg/dL
- Serum total bilirubin <1.5 x institutional upper limits of normal (ULN) 8. Woman of childbearing potential [defined as a sexually mature woman who has not undergone hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e. who has had menses any time in the preceding 24 consecutive months) with a negative serum pregnancy test. In addition, all sexually active woman of childbearing potential and men agreeing to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the duration of study participation and for at least 4 weeks after withdrawal from the study, unless they are surgically sterilised 9. Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- 1. Subjects having received radiotherapy, immunotherapy, chemotherapy and or biological agents like G-CSF in the 2 weeks prior to day 1 of study drug administration and have not recovered completely from the side effects of the earlier investigational agent 2. Subjects having received any other investigational agents within 2 weeks prior to the date of enrolment 3. History of allergic reactions attributed to compounds of similar chemical composition to P276-00 4. Subjects with a history of myocardial infarction or uncontrolled cardiac dysfunction during the previous 6 months 5. Prior malignancy (within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer or any other cancer for which the subject has been disease-free for at least 3 years 6. Subjects with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, known cardiac ejection fraction <40%, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements 7. Women who are pregnant or nursing 8. Subjects known to be seropositive for the human immunodeficiency virus 9. Subjects requiring the use of concomitant medications that prolong the QT/QTc interval and/or are known to cause Torsades de Pointes (TdP) 10. Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the subject at unacceptable risk if he/she were to participate in the study
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: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)
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 |
---|---|
maximum tolerated dose (MTD) in subjects with relapsed and relapsed/refractory Multiple Myeloma (MM)
時間枠:1year
|
1year
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
clinical response of P276-00 in subjects with relapsed and relapsed/refractory MM 2. Exploratory pharmacogenomic analysis of serum and molecular markers associated with P276-00 use in the study population
時間枠:1.5 years
|
1.5 years
|
協力者と研究者
捜査官
- 主任研究者:Sundar Jagannath, MD、St. Vincent's Comprehensive Cancer Center
- 主任研究者:Noopur Raje, MD、Dana-Farber Cancer Institute
- 主任研究者:Sagar Lonial, MD、Winship Cancer Institute,Emory University
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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。
P276-00の臨床試験
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Piramal Enterprises Limited完了
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Piramal Enterprises Limited完了
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National Institute of Allergy and Infectious Diseases...Centers for Disease Control and Prevention; International AIDS Vaccine Initiative; US Military... と他の協力者引きこもった
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University of TorontoDiabetes Canada; Wharton Medical Clinicまだ募集していません
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National Institute of Allergy and Infectious Diseases...HIV Vaccine Trials Network完了
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Piramal Enterprises Limited終了しました
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National Institute of Allergy and Infectious Diseases...完了HIV感染症アメリカ, プエルトリコ, ジンバブエ, 南アフリカ