NCT07402915RecruitingPhase 1
Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
An Open-label, Fixed Sequence Phase I Study to Evaluate the Effect of Itraconazole (a Strong CYP3A Inhibitor) on the Pharmacokinetics of AZ14170132, the TOP1 Inhibitor Payload of the Antibody Drug Conjugate AZD5335, in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
The purpose of this study is to assess the effect of itraconazole on the pharmacokinetics (PK) of AZ14170132.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 23 Jan 2026
- Start date
- 26 Jan 2026
- Primary completion date
- 15 Oct 2027
- Lead sponsor
- AstraZeneca
- Diseases
- Ovarian cancer
- NCT number
- NCT07402915
- EU CT number
- 2025-522731-34-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 32
- From 26 Jan 2026 to the primary completion date, 15 Oct 2027
- 8 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unresolved toxicities of Grade ≥ 2 (National Cancer Institute-Common Terminology Criteria for Adverse Events v5.0) from prior therapy.
- Uncontrolled intercurrent illness within 12 months prior to screening.
- Any other contraindication for receiving itraconazole according to the prescribing information and the Investigator.
Other illness
- Spinal cord compression or a history of leptomeningeal carcinomatosis.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital HM Nou Delfos Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Fundacion Rioja Salud Coordinator of this site? Confirm its status | Logrono | Spain | Recruiting |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| - Coordinator of this site? Confirm its status | Batumi | Georgia | Withdrawn |
| - Coordinator of this site? Confirm its status | Tbilisi | Georgia | Withdrawn |
| Mater Misericordiae University Hospital Coordinator of this site? Confirm its status | Dublin 7 | Ireland | Recruiting |
| Start Research Portugal Unipessoal Lda. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.