Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Официальное название

An Open-label, Fixed Sequence Phase I Study to Evaluate the Effect of Itraconazole (a Strong CYP3A Inhibitor) on the Pharmacokinetics of AZ14170132, the TOP1 Inhibitor Payload of the Antibody Drug Conjugate AZD5335, in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Обзор

The purpose of this study is to assess the effect of itraconazole on the pharmacokinetics (PK) of AZ14170132.

Подробное описание

This is a non-randomized, open-label, fixed sequence study to be conducted at multiple study centers.

The study will consist of 2 parts:

Part A of the study will comprise of:

* Screening period * Treatment period: The treatment period will comprise of Cycles 1, 2 and 3 where the participants will receive AZD5335 along with itraconazole * Follow-up visit (not applicable for participants involved in Part B)

Part B of the study will comprise of:

* Treatment period: Cycle 4 and onwards * Safety Follow-up period

Вмешательства

• Препарат AZD5335
  AZD5335 will be administered as IV infusion.
• Препарат Itraconazole
  Itraconazole capsule will be administered orally.

Первичные конечные точки

• Area under curve from time 0 to time 17 days (AUC0-17days) [Срок оценки: Cycle 2 and Cycle 3 (each cycle is of 21 days)]
• Maximum plasma drug concentration (Cmax) [Срок оценки: Cycle 2 and Cycle 3 (each cycle is of 21 days)]

Вторичные конечные точки (11)

• Maximum plasma drug concentration (Cmax) [Срок оценки: Cycle 2 and Cycle 3 (each cycle is of 21 days)]
• Area under curve from time 0 to time 17 days (AUC0-17days) [Срок оценки: Cycle 2 and Cycle 3 (each cycle is of 21 days)]
• Minimum plasma drug concentration (Cmin) [Срок оценки: Cycle 2 and Cycle 3 (each cycle is of 21 days)]
• Area under curve from time 0 to the time of last measurable concentration (AUC0-t) [Срок оценки: Cycle 2 and Cycle 3 (each cycle is of 21 days)]
• Terminal elimination (lambda_z) [Срок оценки: Cycle 2 and Cycle 3 (each cycle is of 21 days)]
• Half life (t1/2) [Срок оценки: Cycle 2 and Cycle 3 (each cycle is of 21 days)]
• Time to maximum observed concentration (tmax) [Срок оценки: Cycle 2 and Cycle 3 (each cycle is of 21 days)]
• Number of participants with adverse events (AEs) and serious adverse events (SAEs) [Срок оценки: Part A: up to 121 days; Part B: up to 365 days post last participant first dose]
• Objective response rate (ORR) [Срок оценки: Part A: up to 121 days; Part B: up to 365 days post last participant first dose]
• Duration of response (DoR) [Срок оценки: Part A: up to 121 days; Part B: up to 365 days post last participant first dose]
• Progression-free Survival (PFS) [Срок оценки: From Day 1 until until disease progression or death (up to 2 years)]

Критерии участия

Критерии включения

• Participants with Platinum-resistant, relapsed, high- grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer and: (a) have received at least 1 prior line of platinum-containing chemotherapy and have progressed on or within 6 months after the date of the last dose of platinum; (b) must have received prior bevacizumab and/or Poly (ADP-ribose) polymerase (PARP) inhibitors according to local guidelines, unless ineligible.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Критерии исключения

• Spinal cord compression or a history of leptomeningeal carcinomatosis.
• Unresolved toxicities of Grade ≥ 2 (National Cancer Institute-Common Terminology Criteria for Adverse Events v5.0) from prior therapy.
• History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required oral or IV steroids or supplemental oxygen, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
• Uncontrolled intercurrent illness within 12 months prior to screening.
• Any other contraindication for receiving itraconazole according to the prescribing information and the Investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 4 центра

• Research Site — Barcelona
• Research Site — Logroño
• Research Site — Madrid
• Research Site — Madrid

Грузия · 3 центра

• Research Site — Batumi
• Research Site — Tbilisi
• Research Site — Tbilisi

Ирландия · 1 центр

• Research Site — Dublin

Португалия · 1 центр

• Research Site — Lisbon

Идентификаторы

NCT: NCT07402915 · D8991C00002 · EU CT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗