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