Drug-drug Interaction Study with AZD5335 and Itraconazole in Participants with Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Study identifier:D8991C00002
ClinicalTrials.gov identifier:NCT07402915
EudraCT identifier:N/A
CTIS identifier:2025-522731-34-00
Recruiting
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
Medical condition
Fallopian Tube Cancer, Primary peritoneal
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD5335, Itraconazole
Sex
Female
Estimated Enrollment
24
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 26 Jan 2026
Estimated Primary Completion Date: 15 Oct 2027
Estimated Study Completion Date: 15 Oct 2027
Study design
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2026 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: AZD5335/AZD5335 + Itraconazole In Part A, participants will receive AZD5335 alone as an intravenous (IV) infusion, and in combination with oral itraconazole, every 3 weeks (Q3W) from cycle 1 to cycle 3. In Part B, participants will receive AZD5335 as an IV infusion Q3W, from Day 1 of Cycle 4 until progression, unacceptable toxicity or any other specified criteria for discontinuation occurs. | Drug: AZD5335 AZD5335 will be administered as IV infusion. Other Name: AZ14170132 Drug: Itraconazole Itraconazole capsule will be administered orally. |
