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Идёт набор NCT04503265

A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies

Фаза I / Фаза II С лечением Advanced Malignant Neoplasm Breast Cancer Ovarian Cancer Homologous Recombination Deficiency

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: AMXI-5001:Dose Escalation Phase I, AMXI-5001:Dose Expansion Phase II.
Кому может быть актуально
Состояния в реестре: Advanced Malignant Neoplasm, Breast Cancer, Ovarian Cancer, Homologous Recombination Deficiency. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase I/II, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of AMXI-5001 in Patients With Advanced Malignancies

Обзор

ATLAS-101 is a Phase I/II clinical trial of AMXI-5001 in adult participants with advanced malignancies who have previously failed other therapies. The study has two phases. The purpose of Phase I (Dose Escalation) is to confirm the appropriate treatment dose and Phase II (Dose Expansion) is to characterize the safety and efficacy of AMXI-5001.

Подробное описание

AMXI-5001 is an orally available dual PARP (poly adenosine diphosphate \[ADP\] ribose polymerase) and microtubule polymerization inhibitor. ATLAS-101 is a Phase I/II, open label, multi-center, non-randomized Dose Escalation and Dose Expansion study in participants with advanced malignancies. Study enrollment is approximately 122 participants. All participants receive oral AMXI-5001, twice daily, as monotherapy. Following Phase I (Dose Escalation) to identify the Maximum Tolerated Dose and the Recommended Dose for use in Phase II, additional participants will be enrolled into the Dose Expansion Phase to further characterize the safety, pharmacology, and clinical efficacy of AMXI-5001.

Вмешательства

  • Препарат AMXI-5001:Dose Escalation Phase I
    Phase I will enroll up to 70 participants to identify the Recommended Phase II daily dose in the treatment of various cancers and to characterize the safety, pharmacology, and clinical efficacy of AMXI-5001. AMXI-5001 is administered orally twice daily, with food. AMXI-5001 is administered weekly on a continuous 7-day schedule. Each cycle is 28 days.
  • Препарат AMXI-5001:Dose Expansion Phase II
    Phase II will enroll up to 52 study participants to further characterize the safety, pharmacology, and clinical efficacy of AMXI-5001. AMXI-5001 is administered orally twice daily, with food. AMXI-5001 is administered weekly on a continuous 7-day schedule. Each cycle is 28 days.

Первичные конечные точки

  • Determine the Maximum Tolerated Dose (MTD) [Срок оценки: Approximately 12 months]
  • Determine the Recommended Phase 2 Dose (RP2D) for AMXI-5001 as monotherapy [Срок оценки: Approximately 12 months]
  • Characterize safety profile of AMXI-5001 [Срок оценки: Approximately 24 months]
Вторичные конечные точки (2)
  • Measure concentration of AMXI-5001 in plasma samples [Срок оценки: Approximately 24 months]
  • Determine change in anti-tumor activity following administration of AMXI-5001 [Срок оценки: Approximately 24 months]

Критерии участия

Inclusion Criteria (Key Factors):

  • Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:
  • Patient is intolerant of existing therapy(ies) known to provide clinical benefit for their condition
  • Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit
  • Malignancy has progressed after standard therapy
  • Has evaluable or measurable tumor(s) in dose escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.
  • Eastern Co-operative Oncology Group (ECOG) PS 0-1
  • Participant must be 18 years of age or older
  • Able to understand and sign consent

Exclusion Criteria (Key Factors):

  • Receiving cancer treatment at the time of enrollment
  • Any clinically significant disease or condition affecting a major organ system
  • Significant cardiovascular disease or electrocardiogram (ECG) abnormalities
  • Use of a strong inhibitor or inducer of CYP3A4 within 7 days prior to start of study therapy and throughout the study (e.g., some antibiotics, antifungals, anticonvulsants, grapefruit)
  • Has had a previous (within 2 years) or has a current malignancy other than the target cancer

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 4 центра
  • University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology — Los Angeles
  • Johns Hopkins — Baltimore
  • SCRI Oncology Partners — Nashville
  • The University of Texas MD Anderson Cancer Center — Houston

Публикации

  • Lemjabbar-Alaoui H, Peto CJ, Yang YW, Jablons DM. AMXI-5001, a novel dual parp1/2 and microtubule polymerization inhibitor for the treatment of human cancers. Am J Cancer Res. 2020 Aug 1;10(8):2649-2676. eCollection 2020. PMID 32905466

Идентификаторы

NCT: NCT04503265 · ATLAS-101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗