Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Recruiting now · Phase 1
Conditions studied: Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal
In brief
The purpose of this study is to assess the effect of itraconazole on the pharmacokinetics (PK) of AZ14170132.
Key facts
- Study ID
- NCT07402915
- Run by
- AstraZeneca
- People needed
- 24
- Starts
- 2026-01-26
- Expected to finish
- 2027-10-15
- Last updated by the study team
- 2026-07-07
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Research Site — Madrid, Spain (enrolling)
- Research Site — Barcelona, Spain (enrolling)
- Research Site — Logroño, Spain (enrolling)
- Research Site — Madrid, Spain (enrolling)
- Research Site — Dublin, Ireland (enrolling)
- Research Site — Lisbon, Portugal (enrolling)
- Research Site — Tbilisi, Georgia
- Research Site — Tbilisi, Georgia
- Research Site — Batumi, Georgia
Full record on ClinicalTrials.gov
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