Clinical Trials in Spain / NCT07402915
Recruiting
Phase 1
Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
NCT07402915 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Fallopian Tube CancerOvarian CancerPrimary Peritoneal
Investigational drug(s) / intervention(s)
AZD5335: AZD5335 will be administered as IV infusion.
Itraconazole: Itraconazole capsule will be administered orally.
Study summary
The purpose of this study is to assess the effect of itraconazole on the pharmacokinetics (PK) of AZ14170132.
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.
Primary outcome measure(s)
- Area under curve from time 0 to time 17 days (AUC0-17days) — Cycle 2 and Cycle 3 (each cycle is of 21 days)
The effect of itraconazole on the pharmacokinetics (PK) of AZ14170132 will be assessed. - Maximum plasma drug concentration (Cmax) — Cycle 2 and Cycle 3 (each cycle is of 21 days)
The effect of itraconazole on the PK of AZ14170132 will be assessed.
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Batumi | Georgia | Withdrawn |
| Research Site | Tbilisi | Georgia | Withdrawn |
| Research Site | Tbilisi | Georgia | Withdrawn |
| 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 |
More AstraZeneca trials in Spain
A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations
Active, not recruiting
Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer
Active, not recruiting
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Active, not recruiting
A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer
Active, not recruiting
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07402915 on ClinicalTrials.gov ↗ ← All trials in Spain