RecruitingPhase 1NCT07402915

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


Sponsor

AstraZeneca

Enrollment

24 participants

Start Date

Jan 26, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing how a drug called AZD5335 interacts with itraconazole (an antifungal medication) in women with ovarian, fallopian tube, or primary peritoneal cancer. The goal is to understand whether itraconazole changes how the body absorbs and processes AZD5335. **You may be eligible if...** - You have platinum-resistant high-grade ovarian, fallopian tube, or primary peritoneal cancer - You have had at least one prior platinum-based chemotherapy and your cancer progressed within 6 months of the last dose - You have previously received bevacizumab and/or a PARP inhibitor (if applicable based on guidelines) - Your general health is good (ECOG performance status 0 or 1) **You may NOT be eligible if...** - You have spinal cord compression or cancer in the fluid around the brain or spinal cord - You have unresolved side effects (grade 2 or higher) from prior treatment - You have a history of a non-drug-related lung disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAZD5335

AZD5335 will be administered as IV infusion.

DRUGItraconazole

Itraconazole capsule will be administered orally.


Locations(9)

Research Site

Batumi, Georgia

Research Site

Tbilisi, Georgia

Research Site

Tbilisi, Georgia

Research Site

Dublin, Ireland

Research Site

Lisbon, Portugal

Research Site

Barcelona, Spain

Research Site

Logroño, Spain

Research Site

Madrid, Spain

Research Site

Madrid, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07402915


Related Trials