The purpose of this study is to assess the effect of itraconazole on the pharmacokinetics (PK) of AZ14170132.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Area under curve from time 0 to time 17 days (AUC0-17days)
Timeframe: Cycle 2 and Cycle 3 (each cycle is of 21 days)
2
Maximum plasma drug concentration (Cmax)
Timeframe: Cycle 2 and Cycle 3 (each cycle is of 21 days)