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NCT07402915From ClinicalTrials.govRecruiting

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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Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or | Trialion