AZD5335 given with itraconazole for ovarian, fallopian tube, and primary peritoneal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, non-randomized, fixed-sequence Phase 1 study that examines the pharmacokinetic interaction between AZD5335 and the strong CYP3A inhibitor itraconazole. Part A includes screening and three treatment cycles during which participants receive AZD5335 together with itraconazole; Part B covers later treatment cycles and safety follow-up. The study enrolls adults with platinum-resistant, relapsed high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer who meet protocol safety criteria. Pharmacokinetic sampling and safety assessments will be used to determine how itraconazole affects AZD5335 exposure.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Dublin, Ireland Recruiting
• Research Site
  Lisbon, Portugal Recruiting
• Research Site
  Barcelona, Spain Recruiting
• Research Site
  Logroño, Spain Recruiting
• Research Site
  Madrid, Spain Recruiting
• Research Site
  Madrid, Spain Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.