Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

May 19, 2026 updated by: AstraZeneca

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a non-randomized, open-label, fixed sequence study to be conducted at multiple study centers.

The study will consist of 2 parts:

Part A of the study will comprise of:

  • Screening period
  • Treatment period: The treatment period will comprise of Cycles 1, 2 and 3 where the participants will receive AZD5335 along with itraconazole
  • Follow-up visit (not applicable for participants involved in Part B)

Part B of the study will comprise of:

  • Treatment period: Cycle 4 and onwards
  • Safety Follow-up period

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Georgia
      • Batumi, Georgia, 6010
        • Not yet recruiting
        • Research Site
      • Tbilisi, Georgia, 112
        • Not yet recruiting
        • Research Site
      • Tbilisi, Georgia, 0114
        • Not yet recruiting
        • Research Site
  • Ireland
      • Dublin, Ireland, D07 R2WY
        • Recruiting
        • Research Site
  • Portugal
      • Lisbon, Portugal, 1250-068
        • Recruiting
        • Research Site
  • Spain
      • Barcelona, Spain, 08023
        • Recruiting
        • Research Site
      • Logroño, Spain, 26006
        • Recruiting
        • Research Site
      • Madrid, Spain, 28040
        • Recruiting
        • Research Site
      • Madrid, Spain, 28050
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: Itraconazole
Itraconazole capsule will be administered orally.
Drug: AZD5335
AZD5335 will be administered as IV infusion.
Other Names:
  • AZ14170132

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under curve from time 0 to time 17 days (AUC0-17days)
Time Frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
The effect of itraconazole on the pharmacokinetics (PK) of AZ14170132 will be assessed.
Cycle 2 and Cycle 3 (each cycle is of 21 days)
Maximum plasma drug concentration (Cmax)
Time Frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
The effect of itraconazole on the PK of AZ14170132 will be assessed.
Cycle 2 and Cycle 3 (each cycle is of 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum plasma drug concentration (Cmax)
Time Frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Cmax of AZ14170132 will be assessed.
Cycle 2 and Cycle 3 (each cycle is of 21 days)
Area under curve from time 0 to time 17 days (AUC0-17days)
Time Frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
AUC0-17days of AZ14170132 will be assessed.
Cycle 2 and Cycle 3 (each cycle is of 21 days)
Minimum plasma drug concentration (Cmin)
Time Frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Cmin of AZ14170132 will be assessed.
Cycle 2 and Cycle 3 (each cycle is of 21 days)
Area under curve from time 0 to the time of last measurable concentration (AUC0-t)
Time Frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
AUC0-t of AZ14170132 will be assessed.
Cycle 2 and Cycle 3 (each cycle is of 21 days)
Terminal elimination (lambda_z)
Time Frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
lambda_z of AZ14170132 will be assessed.
Cycle 2 and Cycle 3 (each cycle is of 21 days)
Half life (t1/2)
Time Frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
t1/2 of AZ14170132 will be assessed.
Cycle 2 and Cycle 3 (each cycle is of 21 days)
Time to maximum observed concentration (tmax)
Time Frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
tmax of AZ14170132 will be assessed.
Cycle 2 and Cycle 3 (each cycle is of 21 days)
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Part A: up to 121 days; Part B: up to 365 days post last participant first dose
The safety and tolerability of AZD5335 alone and in combination with itraconazole will be assessed.
Part A: up to 121 days; Part B: up to 365 days post last participant first dose
Objective response rate (ORR)
Time Frame: Part A: up to 121 days; Part B: up to 365 days post last participant first dose
The ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR), with the denominator defined as the number of participants in the response evaluable set.
Part A: up to 121 days; Part B: up to 365 days post last participant first dose
Duration of response (DoR)
Time Frame: Part A: up to 121 days; Part B: up to 365 days post last participant first dose
The DoR is defined as the time from the date of first documented objective response (which is subsequently confirmed) until date of first documented disease progression or death (by any cause in the absence of disease progression).
Part A: up to 121 days; Part B: up to 365 days post last participant first dose
Progression-free Survival (PFS)
Time Frame: From Day 1 until until disease progression or death (up to 2 years)
The PFS is defined as the time from the start of treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy prior to progression.
From Day 1 until until disease progression or death (up to 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2026

Primary Completion (Estimated)

October 15, 2027

Study Completion (Estimated)

October 15, 2027

Study Registration Dates

First Submitted

January 23, 2026

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8991C00002
  • EU CT (Other Identifier: 2024-512981-33-00)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitment a made to the EFPIA PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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