A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of AZD5335 and the Effect of Itraconazole Co-administration in Adults with Ovarian, Peritoneal, or Fallopian Tube Cancer

The primary objective of this study is to evaluate the safety and pharmacokinetics of AZD5335 in adults diagnosed with ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. Additionally, the study aims to assess the effect of itraconazole on the pharmacokinetics of AZD5335 to determine potential drug-drug interactions. 4, 6

The sponsor did not provide information regarding the total number of participants. The study population consists of female patients belonging to vulnerable populations. The age range of the subjects corresponds to codes 3 and 4. Participants are diagnosed with ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

This Phase 3 clinical trial utilizes a study design to evaluate the safety of AZD5335 and to investigate the impact of itraconazole on the pharmacokinetics of AZD5335 in adults diagnosed with ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. The research methodology involves a sequence of study visits, beginning with a screening visit to determine eligibility. Subsequent follow-up visits and an end-of-study visit are scheduled to monitor safety and drug movement through the body. The total duration of the trial is estimated to conclude by December 31, 2028, with the expected length of participant involvement being determined by the specific protocol requirements. Conditions leading to early termination from the study may occur based on safety monitoring or protocol deviations.

The assessment of efficacy in this phase 3 clinical trial is focused on patients with ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.