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Mass Balance, Pharmacokinetics and Metabolism Study of IXAZOMIB

2020년 8월 25일 업데이트: 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.

연구 개요

상태

완전한

개입 / 치료

연구 유형

중재적

등록 (실제)

7

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Ohio
      • Cleveland, Ohio, 미국

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Part A: Cmax: Maximum Observed Plasma Concentration for Ixazomib
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Ixazomib and Metabolites as Percent of Total Radioactivity in Plasma
기간: 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
기간: 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
기간: 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)
기간: 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
기간: Baseline up to Cycle 5 Day 45
Baseline up to Cycle 5 Day 45
Number of Participants With TEAEs Related to Vital Signs
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

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연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2014년 3월 19일

기본 완료 (실제)

2014년 12월 17일

연구 완료 (실제)

2016년 2월 9일

연구 등록 날짜

최초 제출

2013년 9월 26일

QC 기준을 충족하는 최초 제출

2013년 9월 26일

처음 게시됨 (추정)

2013년 10월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 8월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 8월 25일

마지막으로 확인됨

2020년 8월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

IXAZOMIB에 대한 임상 시험

3
구독하다