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Mass Balance, Pharmacokinetics and Metabolism Study of IXAZOMIB

2020年8月25日 更新者:Millennium Pharmaceuticals, Inc.

A Phase 1 Study of [ 14 C]-Ixazomib to Assess Mass Balance, Pharmacokinetics, and Metabolism in Patients With Advanced Solid Tumors or Lymphoma

This is a phase 1, 2-part, open-label study in 4 to 6 pharmacokinetic-evaluable participants with advanced solid tumors or lymphoma.

調査の概要

状態

完了

介入・治療

研究の種類

介入

入学 (実際)

7

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

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:

Each participant must meet all of the following inclusion criteria to be enrolled in the study:

  • 18 years or older
  • Histologic or cytologic diagnosis of advanced or metastatic solid tumor or lymphoma for which no standard, curative, or life-prolonging therapies exist or are effective
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • Female participants who are postmenopausal for at least 1 year OR are surgically sterile OR if of childbearing potential, agree to practice 2 effective methods of contraception at the same time during the entire study through 90 days after the last dose of study drug OR agree to practice true abstinence
  • Male participants who agree to practice effective barrier contraception during the entire study and through 90 days after the last dose of study drug OR agree to practice true abstinence
  • Voluntary written consent
  • Suitable venous access for the conduct of blood sampling
  • Recovered from the reversible effects of prior anticancer therapy

Exclusion Criteria:

Participants meeting any of the following exclusion criteria are not to be enrolled in the study:

  • Female participants who are lactating or breastfeeding or have a positive serum pregnancy test
  • Serious medical or psychiatric illness that could interfere with the study
  • Treatment with any investigational products or radiotherapy within 21 days before the first dose of study drug
  • Peripheral neuropathy greater than (>) Grade 2
  • Systemic treatment with strong and moderate inhibitors of CYP1A2, strong and moderate inhibitors of CYP3A, or clinically significant CYP3A inducers or use of Ginkgo biloba or St. John's wort within 14 days before the first dose of study drug
  • Symptomatic brain metastasis. Participants with brain metastases: must have stable neurologic status following local therapy (surgery or radiation) for at least 2 weeks after completion of the definitive therapy; and must be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events (AEs)
  • Ongoing treatment with corticosteroids
  • Major surgery within the 14 days preceding the first dose of study drug
  • Infection requiring systemic intravenous antibiotic therapy or other serious infection within 14 days before the first dose of study drug
  • Life-threatening illness unrelated to cancer
  • Known hepatitis B surface antigen -positive, or known or suspected active hepatitis C infection or human immunodeficiency virus (HIV) positive
  • Diagnosed or treated for another malignancy within 2 years before the first dose, OR previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection
  • Any cardiovascular condition specified in the study protocol
  • Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of IXAZOMIB
  • History of urinary and/or fecal incontinence
  • Inability to comply with study procedures or visit schedule including the requirement for inpatient confinement

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
実験的:IXAZOMIB

Part A: Participants will receive a single dose of 4.1-milligram (mg) [14C]-IXAZOMIB oral solution containing approximately 500-nCurie (nCi) of total radioactivity on Day 1 and remain at the clinic for 8 days. On Days 14 and 21, participants may be administered a single 4.0-mg capsule of IXAZOMIB. Participants will return to the clinic in the evening before Days 14, 21, 28, and 35 for a 24-hour overnight clinic visit.

Part B: Eligible participants from Part A may continue into Part B once they have completed their Day 35 assessments in Part A. Participants may receive IXAZOMIB capsules administered orally at a dose of 4.0-mg once weekly on Days 1, 8, and 15 of 28-day cycles. Participants will continue in this study until disease progression or unacceptable toxicity.

Part A: Ixazomib 4.1 mg containing approximately 500-nCi [14C]-ixazomib, solution, orally on Day 1 and ixazomib 4 mg, capsule, orally on Days 14 and 21.

Part B: Ixazomib 4 mg, capsule, orally, once weekly, on Days 1, 8 and 15 in 28-day cycles until disease progression or unacceptable toxicity.

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
Part A: Cmax: Maximum Observed Plasma Concentration for Ixazomib
時間枠:Day 1 of Part A pre-dose and at multiple timepoints (up to Day 14) post-dose
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of ixazomib, obtained directly from the plasma concentration-time curve.
Day 1 of Part A pre-dose and at multiple timepoints (up to Day 14) post-dose
Part A: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Ixazomib
時間枠:Day 1 of Part A pre-dose and at multiple timepoints (up to Day 14) post-dose
Time to reach the maximum observed plasma concentration (Cmax), equal to time (hours) to Cmax of ixazomib after administration, obtained directly from the plasma concentration-time curve.
Day 1 of Part A pre-dose and at multiple timepoints (up to Day 14) post-dose
Part A: AUC(0-312): Area Under the Plasma Concentration-time Curve From Time 0 to 312 Hrs Post-dose for Ixazomib
時間枠:Day 1 of Part A pre-dose and at multiple timepoints (up to 312 hrs) post-dose
AUC(0-312) is a measure of the area under the plasma concentration time-curve from time zero to 312 hrs post-dose for ixazomib.
Day 1 of Part A pre-dose and at multiple timepoints (up to 312 hrs) post-dose
Part A: Cmax: Maximum Observed Plasma Concentration of TRA
時間枠:Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose
Maximum observed plasma concentration (Cmax) of TRA is the peak plasma concentration of TRA, obtained directly from the plasma TRA concentration-time curve.
Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose
Part A: Tmax: Time to Reach the Cmax for TRA
時間枠:Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose
Time to reach the maximum observed plasma concentration (Cmax) for TRA, equal to time (hours) to Cmax for TRA after administration, obtained directly from the plasma TRA concentration-time curve.
Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose
Part A: AUC(0-816): Area Under the Plasma Concentration-time Curve From Time 0 to 816 Hrs Post-dose for TRA
時間枠:Day 1 of Part A pre-dose and at multiple timepoints (up to 816 hrs) post-dose
AUC(0-816) is a measure of the area under the plasma concentration time-curve from time zero to 816 hrs post-dose for TRA.
Day 1 of Part A pre-dose and at multiple timepoints (up to 816 hrs) post-dose
Part A: Cmax: Maximum Observed Whole Blood Concentration of TRA
時間枠:Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose
Maximum observed whole blood concentration (Cmax) of a TRA is the peak whole blood concentration of TRA, obtained directly from the whole blood TRA concentration-time curve.
Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose
Part A: Tmax: Time to Reach the Maximum Observed Whole Blood Concentration (Cmax) for TRA
時間枠:Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose
Time to reach the maximum observed whole blood concentration (Cmax) for TRA, equal to time (hours) to Cmax for TRA after administration, obtained directly from the whole blood TRA concentration-time curve.
Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose
Part A: AUC(0-816): Area Under the Whole Blood Concentration-time Curve From Time 0 to 816 Hrs Post-dose for TRA
時間枠:Day 1 of Part A pre-dose and at multiple timepoints (up to 816 hrs) post-dose
AUC(0-816) is a measure of the area under the whole blood concentration time-curve from time zero to 816 hrs post-dose for TRA.
Day 1 of Part A pre-dose and at multiple timepoints (up to 816 hrs) post-dose
Part A: Cumulative Percentage of Ixazomib Dose Recovered in the Urine
時間枠:Day 1 of Part A from 0 to pre-dose and at multiple timepoints (up to 168 hrs) post-dose
Percentage of the ixazomib dose excreted unchanged in the urine from 0 to 168 hrs post-dose.
Day 1 of Part A from 0 to pre-dose and at multiple timepoints (up to 168 hrs) post-dose
Part A: Cumulative Percentage of the Total Radioactivity Dose Excreted in Feces
時間枠:Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose
Percentage of the TRA dose excreted in feces from Day 1 to Day 35 of Part A
Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose
Part A: Cumulative Percentage of the Total Radioactivity Dose Excreted in Urine
時間枠:Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose
Percentage of the TRA dose excreted in urine from Day 1 to Day 35 of Part A.
Day 1 of Part A pre-dose and at multiple timepoints (up to Day 35) post-dose
Part A: Renal Clearance of Ixazomib
時間枠:Day 1 pre-dose and at multiple timepoints (up to Day 14) post-dose
Renal clearance is the volume of plasma from which ixazomib is completely removed by the kidney in a given amount of time, calculated as the amount of ixazomib excreted in the urine divided by the area under the plasma ixazomib concentration-time curve.
Day 1 pre-dose and at multiple timepoints (up to Day 14) post-dose

二次結果の測定

結果測定
メジャーの説明
時間枠
Ixazomib and Metabolites as Percent of Total Radioactivity in Plasma
時間枠:Day 1 pre-dose and at multiple time points (up to 816 hrs) post-dose
The plasma samples were pooled for participants over 816 hrs post-dose, and data was analysed using the Hamilton method time-proportional pooling, and therefore the data is reported as "percent of total radioactivity in plasma" with measure type as "number" and measure dispersion as "Not applicable, NA".
Day 1 pre-dose and at multiple time points (up to 816 hrs) post-dose
Ixazomib and Metabolites as Percent of Total Dose Administered in Urine
時間枠:Day 1 pre-dose and at multiple time points (up to Day 35) post-dose
The 35-day post-dose data is extrapolated from the average of four participant data from 0-168-hr pooled urine. The data is therefore reported as "percentage of dose" with measure type as "number" and measure dispersion as "NA".
Day 1 pre-dose and at multiple time points (up to Day 35) post-dose
Ixazomib and Metabolites as Percent of Total Dose Administered in Feces
時間枠:Day 1 pre-dose and at multiple time points (up to Day 35) post-dose
The 35-day post-dose data is extrapolated from the average of four participant data from 0-168-hr pooled feces. The data is therefore reported as "percentage of dose" with measure type as "number" and measure dispersion as "NA".
Day 1 pre-dose and at multiple time points (up to Day 35) post-dose
Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
時間枠:Baseline up to Cycle 5 Day 45
Baseline up to Cycle 5 Day 45
Number of Participants With TEAEs Related to Investigations System Organ Class for Laboratory Values
時間枠:Baseline up to Cycle 5 Day 45
Baseline up to Cycle 5 Day 45
Number of Participants With TEAEs Related to Vital Signs
時間枠:Baseline up to Cycle 5 Day 25
Vital signs included oral body temperature, heart rate, and blood pressure.
Baseline up to Cycle 5 Day 25

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。

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 (実際)

2014年3月19日

一次修了 (実際)

2014年12月17日

研究の完了 (実際)

2016年2月9日

試験登録日

最初に提出

2013年9月26日

QC基準を満たした最初の提出物

2013年9月26日

最初の投稿 (見積もり)

2013年10月1日

学習記録の更新

投稿された最後の更新 (実際)

2020年8月26日

QC基準を満たした最後の更新が送信されました

2020年8月25日

最終確認日

2020年8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。

IXAZOMIBの臨床試験

3
購読する