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Recruiting NCT07402915

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

Phase I Interventional Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AZD5335, Itraconazole.
Who it may be relevant to
Registry conditions: Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Georgia, Ireland, Portugal, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

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

Interventions

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

Primary outcome measures

  • Area under curve from time 0 to time 17 days (AUC0-17days) [Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)]
  • Maximum plasma drug concentration (Cmax) [Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)]
Secondary outcome measures (11)
  • Maximum plasma drug concentration (Cmax) [Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)]
  • Area under curve from time 0 to time 17 days (AUC0-17days) [Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)]
  • Minimum plasma drug concentration (Cmin) [Time frame: 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) [Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)]
  • Terminal elimination (lambda_z) [Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)]
  • Half life (t1/2) [Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)]
  • Time to maximum observed concentration (tmax) [Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)]
  • Number of participants with adverse events (AEs) and serious adverse events (SAEs) [Time frame: Part A: up to 121 days; Part B: up to 365 days post last participant first dose]
  • Objective response rate (ORR) [Time frame: Part A: up to 121 days; Part B: up to 365 days post last participant first dose]
  • Duration of response (DoR) [Time frame: Part A: up to 121 days; Part B: up to 365 days post last participant first dose]
  • Progression-free Survival (PFS) [Time frame: From Day 1 until until disease progression or death (up to 2 years)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 4 centers
  • Research Site — Barcelona
  • Research Site — Logroño
  • Research Site — Madrid
  • Research Site — Madrid
Georgia · 3 centers
  • Research Site — Batumi
  • Research Site — Tbilisi
  • Research Site — Tbilisi
Ireland · 1 center
  • Research Site — Dublin
Portugal · 1 center
  • Research Site — Lisbon

Identifiers

NCT: NCT07402915 · D8991C00002 · EU CT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗