Tests how itraconazole affects AZD5335 in ovarian, peritoneal, or fallopian tube cancer
Studies how itraconazole changes the body's handling of AZD5335 in adults with gynecologic cancers.
Plain-language title generated from the registry record
Registry title: Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Key facts
- Where
- Dublin 7, IrelandSee the site
- Phase
- Phase 1
Where in Ireland
- Mater Misericordiae University HospitalDublin 7, IrelandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07402915EU 2025-522731-34-00
- Record updated
- 29 September 2026
- Original description
The purpose of this study is to assess the effect of itraconazole on the pharmacokinetics (PK) of AZ14170132.Read full original descriptionShow less
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
The purpose of this study is to assess the effect of itraconazole on the pharmacokinetics (PK) of AZ14170132.
Inclusion: 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: Unresolved toxicities of Grade ≥ 2 (National Cancer Institute-Common Terminology Criteria for Adverse Events v5.0) from prior therapy; Uncontrolled intercurrent illness within 12 months prior to screening; Any other contraindication for receiving itraconazole according to the prescribing information and the Investigator; Spinal cord compression or a history of leptomeningeal carcinomatosis; 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.