AZD5335: AZD5335 will be administered as IV infusion.
Itraconazole: Itraconazole capsule will be administered orally.
Study summary
The purpose of this study is to assess the effect of itraconazole on the pharmacokinetics (PK) of AZ14170132.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Area under curve from time 0 to time 17 days (AUC0-17days) — Cycle 2 and Cycle 3 (each cycle is of 21 days) The effect of itraconazole on the pharmacokinetics (PK) of AZ14170132 will be assessed.
Maximum plasma drug concentration (Cmax) — Cycle 2 and Cycle 3 (each cycle is of 21 days) The effect of itraconazole on the PK of AZ14170132 will be assessed.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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