Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

ConditionsFallopian Tube Cancer Ovarian Cancer Primary Peritoneal

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexFemale

Age18+

SponsorAstraZeneca

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.