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NCT Number: NCT07402915

Drug-drug Interaction Study With AZD5335 and Itraconazole 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.

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Key information

Conditions

Fallopian Tube Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Primary Peritoneal Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Batumi, Georgia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD5335

Drug

AZD5335 will be administered as IV infusion.

Other names: AZ14170132

Itraconazole

Drug

Itraconazole capsule will be administered orally.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Maximum plasma drug concentration (Cmax)

    Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)

    Cmax of AZ14170132 will be assessed.

  2. 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.

  3. Minimum plasma drug concentration (Cmin)

    Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)

    Cmin of AZ14170132 will be assessed.

  4. 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.

  5. Terminal elimination (lambda_z)

    Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)

    lambda_z of AZ14170132 will be assessed.

  6. Half life (t1/2)

    Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)

    t1/2 of AZ14170132 will be assessed.

  7. 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.

  8. 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.

  9. 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.

  10. 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).

  11. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 11, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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