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

Study Identifier:
D8991C00002
CT.gov Identifier:
NCT07402915
EudraCT Identifier:
202552000000
EU Trial (CTIS) Number:
2025-522731-34-00
Study Contact Information:
N/A
Recruiting

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Study Summary

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

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Fallopian Tube
  • Ovarian
  • Primary Peritoneal
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female
    Age
    18+ years
    Study Drug
  • Drug: EXPERIMENTAL: AZD5335/AZD5335 + Itraconazole
    • Read More
  • Drug: 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: Drug: AZD5335
  • Drug: AZD5335 will be administered as IV infusion.
  • Drug: Other Names: AZ14170132
  • Drug: Drug: Itraconazole
  • Drug: Itraconazole capsule will be administered orally.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Lisbon
    Lisbon, Portugal, 1649-035
    Investigator
    Andre Mansinho
    Status
    Recruiting
    Condition(s) Treated at Site
    Fallopian Tube
    Ovarian
    Primary Peritoneal
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Ester Garcia Lorenzo
    Status
    Recruiting
    Condition(s) Treated at Site
    Fallopian Tube
    Ovarian
    Primary Peritoneal
    Location
    START Barcelona
    Barcelona, Spain, 08023
    Investigator
    Tatiana Hernandez Guerrero
    Status
    Recruiting
    Condition(s) Treated at Site
    Fallopian Tube
    Ovarian
    Primary Peritoneal
    Location
    START Dublin
    Dublin, Ireland, D07 R2WY
    Investigator
    Austin Duffy
    Status
    Recruiting
    Condition(s) Treated at Site
    Fallopian Tube
    Ovarian
    Primary Peritoneal
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Emiliano Calvo
    Status
    Recruiting
    Condition(s) Treated at Site
    Fallopian Tube
    Ovarian
    Primary Peritoneal
    Location
    START La Rioja
    Logroño, La Rioja, Spain, 26006
    Investigator
    Maria de Miguel
    Status
    Recruiting
    Condition(s) Treated at Site
    Fallopian Tube
    Ovarian
    Primary Peritoneal