이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

진행성 악성 종양 및 간 기능 장애 환자를 대상으로 한 펠라브레시브의 약동학 및 안전성 연구

2026년 9월 17일 업데이트: Novartis Pharmaceuticals

진행성 악성종양 및 간 기능 장애 환자에서 Pelabresib(DAK539/CPI-0610)의 약동학적 특성을 평가하기 위한 1b상, 개방형, 다기관 연구

The primary purpose of this study is to evaluate the impact of hepatic function on the pharmacokinetic (PK) profile of pelabresib in participants with advanced malignancies who have either hepatic impairment (HI) or normal liver function. To reduce participant burden and maximize benefit, the PK of pelabresib will be assessed at steady-state rather than after a single dose, avoiding treatment-free washout periods.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

This study consists of 2 main parts: Part 1 will assess the PK characteristics of pelabresib in participants with hepatic impairment versus normal hepatic function, and during Part 2, extended treatment with pelabresib may be offered in case of clinical benefit, as assessed by the investigator.

A participant is considered to have started the study and entered the screening period upon signing the informed consent form (ICF). Enrollment occurs when participant receive their first dose of study treatment via the IRT system. A participant is considered to have completed the study if they have completed all phases of the study including the end of treatment (EOT) and 30-day safety follow-up visits. Participants with hematological malignancies will be followed up every 3 months beyond EOT.

Part 1: Impact of hepatic impairment on pelabresib PK

In Part 1, the PK characteristics of pelabresib will be investigated in participants with advanced malignancies comprising 2 different study groups according to their hepatic function:

  • Group 1 includes participants with normal hepatic function
  • Group 2 includes participants with moderate or severe HI

Following completion of Part 1, participants can directly proceed to Part 2

Part 2: Continued treatment After completing Part 1, in case of clinical benefit, participants can continue with pelabresib treatment in Part 2 until the end of study (EOS) is reached, until the participant meets discontinuation criteria, or until they receive pelabresib treatment via alternative means of access, whichever occurs first. Clinical benefit is determined by the investigator.

End of treatment visit An EOT visit is required for all participants within 7 days of the last dose of pelabresib treatment (or within 7 days of the decision to discontinue treatment, if the decision was made > 7 days after the last dose).

30-day safety follow-up All participants will be followed up for AEs and serious AEs (SAEs) for 30 days (±3 days) following the last dose of pelabresib. If the participant starts another anticancer treatment or switches to pelabresib treatment via an alternative source (e.g., in an extension study or commercially available pelabresib), the safety follow-up will end at the time of the first administration of the respective treatment.

Leukemic transformation follow-up for participants with hematological malignancies After the EOT visit and the 30-Day safety follow-up visit, participants with hematological malignancies will be followed up every 3 months for leukemic transformation until the overall end of the study, confirmation of AML, withdrawal of consent, loss to follow-up, or death, whichever occurs first.

연구 유형

중재적

등록 (추정된)

24

단계

  • 1단계

연락처 및 위치

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

연구 연락처

연구 연락처 백업

연구 장소

  • 스페인
      • Barcelona, 스페인, 08023
        • 모병
        • Novartis Investigative Site
      • Madrid, 스페인, 28040
        • 모병
        • Novartis Investigative Site
      • Madrid, 스페인, 28050
        • 모병
        • Novartis Investigative Site
    • Madrid
      • Pozuelo de Alarcón, Madrid, 스페인, 28223
        • 모병
        • Novartis Investigative Site
  • 영국
      • London, 영국, W12 0HS
        • 모병
        • Novartis Investigative Site
  • 이탈리아
    • MI
      • Milan, MI, 이탈리아, 20132
        • 모병
        • Novartis Investigative Site
      • Milan, MI, 이탈리아, 20141
        • 모병
        • Novartis Investigative Site
    • TO
      • Candiolo, TO, 이탈리아, 10060
        • 모병
        • Novartis Investigative Site
  • 프랑스
      • Bordeaux, 프랑스, 33075
        • 모병
        • Novartis Investigative Site
      • Saint-Herblain, 프랑스, 44805
        • 모병
        • Novartis Investigative Site

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 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Key Inclusion Criteria:

  • Is at least 18 and not older than 75 years of age at the time of signing the informed consent.

  • Group 1 only: There is a matching participant in Group 2 and an enrollment slot is available for the Group 1 participant.

  • Has a confirmed documented diagnosis of an advanced malignancy for which no standard and/or curative treatment options are available.

  • Has the following acceptable laboratory assessments prior to the first dose of study treatment:

    1. Platelet count ≥ 150 × 109 /L in the absence of thrombopoietic factors or transfusions within 2 weeks of the screening assessment
    2. Absolute neutrophil count (ANC) ≥ 1 × 109 /L in the absence of granulocyte growth factors
    3. Adequate renal function (creatinine clearance of ≥30 mL/min, calculated using Cockcroft-Gault formula)
    4. Peripheral blood blast count < 5%. Assessment of blasts in bone marrow is not mandatory at screening, however, blasts must be <5% if the assessment is performed.

  • Has a life expectancy ≥3 months.

  • Has fully recovered from major surgery and from the acute toxic effects of prior chemotherapy and radiotherapy .

  • Hepatic function:

    1. Is in Group 1 and is classified as having normal hepatic function based on NCI-ODWG criteria (i.e., total bilirubin ≤ upper limit of normal (ULN) and aspartate aminotransferase (AST) ≤ ULN); or

    2. Is in Group 2 and has stable moderate or severe HI as defined by NCI ODWG criteria:

      • moderate HI: total bilirubin >1.5 × to 3 × ULN, and any AST value
      • severe HI: total bilirubin > 3 × ULN, and any AST value

Key Exclusion Criteria:

  • Has a history of hypersensitivity to the study treatment or its excipients or to drugs of similar chemical class.
  • Has any other medical condition which, in the investigator's opinion, makes the participant unsuitable for the study.
  • Is a female participant who is pregnant (confirmed by a pregnancy test at screening) or is breastfeeding.
  • Is a woman of childbearing potential (WOCBP) who does not agree to follow the contraceptive guidance during the treatment period and for at least 184 days after the last dose of study treatment, and who does not agree to refrain from donating eggs during this period.
  • Has esophageal variceal bleeding within the past 2 months prior to the first dose of pelabresib.
  • Has an active clinically significant infection.
  • Has impaired cardiac function or clinically significant cardiac diseases
  • Has a GI tumor, impaired GI function, GI disease, or significant resection of stomach or other portion of the GI tract that could alter the absorption of pelabresib, including any unresolved nausea, vomiting, or diarrhea.

Other protocol-defined inclusion/exclusion criteria may apply.

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: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Group 1 (normal hepatic function)

Part 1: Participants receive pelabresib 125 mg orally (PO) once daily (QD) for 14 days, followed by a 7-day break (1 cycle = 21 days).

If clinical benefit is observed, treatment continues in Part 2 until end of study (EOS), discontinuation criteria, or alternative access.
의약품: pelabresib

pelabresib 125 mg orally (PO) once daily (QD) for 14 days, followed by a 7-day break

다른 이름들:
  • DAK539 (이전 CPI-0610)
실험적: Group 2 (moderate or severe HI)

Part 1: Participants receive pelabresib 125 mg orally (PO) once daily (QD) for 14 days, followed by a 7-day break (1 cycle = 21 days).

If clinical benefit is observed, treatment continues in Part 2 until end of study (EOS), discontinuation criteria, or alternative access.
의약품: pelabresib

pelabresib 125 mg orally (PO) once daily (QD) for 14 days, followed by a 7-day break

다른 이름들:
  • DAK539 (이전 CPI-0610)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Area Under the Curve from 0 to 24 hours on Day 14 (AUC₀-24h,D14) of pelabresib at steady state per study group
기간: Cycle 1 Day 14: 0, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose (1 cycle = 21 days)

Venous whole blood samples will be collected for pharmacokinetics characterization. AUC₀-24h,D14 of pelabresib at steady state per study group will be listed and summarized using descriptive statistics.
Cycle 1 Day 14: 0, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose (1 cycle = 21 days)
Maximum Plasma Concentration on Day 14 (Cmax,D14) of pelabresib at steady state per study group
기간: Cycle 1 Day 14 (1 cycle = 21 days)

Venous whole blood samples will be collected for pharmacokinetics characterization. Cmax,D14 of pelabresib at steady state per study group will be listed and summarized using descriptive statistics.
Cycle 1 Day 14 (1 cycle = 21 days)
Apparent Clearance (CL/F) of pelabresib at steady state per study group
기간: Cycle 1 Day 14 (1 cycle = 21 days)

Venous whole blood samples will be collected for pharmacokinetics characterization. CL/F of pelabresib at steady state per study group will be listed and summarized using descriptive statistics.
Cycle 1 Day 14 (1 cycle = 21 days)
Apparent Volume of Distribution (V/F) of pelabresib at steady state per study group
기간: Cycle 1 Day 14 (1 cycle = 21 days)

Venous whole blood samples will be collected for pharmacokinetics characterization. V/F of pelabresib at steady state per study group will be listed and summarized using descriptive statistics.
Cycle 1 Day 14 (1 cycle = 21 days)
Terminal Half-Life (T½) of pelabresib at steady state per study group
기간: Cycle 1 Day 14 (1 cycle = 21 days)

Venous whole blood samples will be collected for pharmacokinetics characterization. T½ of pelabresib at steady state per study group will be listed and summarized using descriptive statistics.
Cycle 1 Day 14 (1 cycle = 21 days)

2차 결과 측정

결과 측정
측정값 설명
기간
Maximum Plasma Concentration on Day 1 (Cmax,D1) of pelabresib per study group
기간: Cycle 1 Day 1 (1 cycle = 21 days)

Venous whole blood samples will be collected for pharmacokinetics characterization. Cmax,D1 of pelabresib per study group will be listed and summarized using descriptive statistics.
Cycle 1 Day 1 (1 cycle = 21 days)
Area Under the Curve from 0 to 24 hours on Day 1 (AUC₀-24h,D1) of pelabresib per study group
기간: Cycle 1 Day 1: 0, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose (1 cycle = 21 days)

Venous whole blood samples will be collected for pharmacokinetics characterization. AUC₀-24h,D1 of pelabresib per study group will be listed and summarized using descriptive statistics.
Cycle 1 Day 1: 0, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose (1 cycle = 21 days)
Trough Concentration on Day 14 (Ctrough,D14) of pelabresib per study group
기간: Cycle 1 Day 14: predose (1 cycle = 21 days)

Venous whole blood samples will be collected for pharmacokinetics characterization. Ctrough,D14 of pelabresib per study group will be listed and summarized using descriptive statistics.
Cycle 1 Day 14: predose (1 cycle = 21 days)
Accumulation Ratio (Rac) of pelabresib per study group
기간: Cycle 1: Day 14 compared to Day 1 (1 cycle = 21 days)

Venous whole blood samples will be collected for pharmacokinetics characterization. Rac of pelabresib per study group will be listed and summarized using descriptive statistics.
Cycle 1: Day 14 compared to Day 1 (1 cycle = 21 days)
Time to Maximum Concentration (Tmax) of pelabresib per study group
기간: Cycle 1: Day 1 and Day 14 (1 cycle = 21 days)

Venous whole blood samples will be collected for pharmacokinetics characterization. Tmax of pelabresib per study group will be listed and summarized using descriptive statistics.
Cycle 1: Day 1 and Day 14 (1 cycle = 21 days)
Terminal Half-Life (T½) of pelabresib per study group
기간: Cycle 1 Day 1 (1 cycle = 21 days)

Venous whole blood samples will be collected for pharmacokinetics characterization. T½ of pelabresib per study group will be listed and summarized using descriptive statistics.
Cycle 1 Day 1 (1 cycle = 21 days)
Fraction Unbound (fu) of pelabresib per study group
기간: Cycle 1 Day 14: 0, 2, and 8 hours postdose (1 cycle = 21 days)

Venous whole blood samples will be collected for pharmacokinetics characterization. fu of pelabresib per study group will be listed and summarized using descriptive statistics.
Cycle 1 Day 14: 0, 2, and 8 hours postdose (1 cycle = 21 days)
fu-adjusted AUC of pelabresib per study group
기간: Cycle 1: Day 1 and Day 14 (1 cycle = 21 days)

Venous whole blood samples will be collected for pharmacokinetics characterization. fu-adjusted AUC of pelabresib per study group will be listed and summarized using descriptive statistics.
Cycle 1: Day 1 and Day 14 (1 cycle = 21 days)
fu-adjusted Cmax of pelabresib per study group
기간: Cycle 1: Day 1 and Day 14 (1 cycle = 21 days)

Venous whole blood samples will be collected for pharmacokinetics characterization. fu-adjusted Cmax of pelabresib per study group will be listed and summarized using descriptive statistics.
Cycle 1: Day 1 and Day 14 (1 cycle = 21 days)
fu-adjusted Ctrough of pelabresib per study group
기간: Cycle 1 Day 1 and Day 14: predose (1 cycle = 21 days)

Venous whole blood samples will be collected for pharmacokinetics characterization. fu-adjusted Ctrough of pelabresib per study group will be listed and summarized using descriptive statistics.
Cycle 1 Day 1 and Day 14: predose (1 cycle = 21 days)
Number of Participants with adverse events (AEs), serious AEs (SAEs)
기간: Through study completion, an average of 28 months

Incidence of adverse events by type, frequency, and severity, as graded by the NCI CTCAE version 5.0.
Through study completion, an average of 28 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Novartis Pharmaceuticals

수사관

  • 연구 책임자: Novartis Pharmaceuticals, Novartis Pharmaceuticals

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)

2026년 5월 19일

기본 완료 (추정된)

2028년 6월 28일

연구 완료 (추정된)

2028년 8월 2일

연구 등록 날짜

최초 제출

2026년 1월 22일

QC 기준을 충족하는 최초 제출

2026년 2월 12일

처음 게시됨 (실제)

2026년 2월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 17일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CDAK539A12103
  • 2025-521001-40-00 (레지스트리 식별자: EU CT Number)
  • 2025 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

구독하다