Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
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
- Fallopian Tube Cancer
- Ovarian Cancer
- Primary Peritoneal
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- AstraZeneca
- Enrolment target
- 32
- Started
- 26 January 2026
- Main results due
- 15 October 2027
- Study sites
- 9
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Women only.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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.
What this study is about
In the sponsor’s own words, from the registry.
The purpose of this study is to assess the effect of itraconazole on the pharmacokinetics (PK) of AZ14170132.
Study sites(9)
Research Site
Batumi, Georgia
Withdrawn
Research Site
Tbilisi, Georgia
Withdrawn
Research Site
Tbilisi, Georgia
Withdrawn
Research Site
Dublin, Ireland
Recruiting
Research Site
Lisbon, Portugal
Recruiting
Research Site
Barcelona, Spain
Recruiting
Research Site
Logroño, Spain
Recruiting
Research Site
Madrid, Spain
Recruiting
Research Site
Madrid, Spain
Recruiting
Showing 9 of 9 sites. 6 of the 9 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07402915. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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