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Taking people in PortugalPhase 1

Tests how itraconazole affects AZD5335 in ovarian, peritoneal, or fallopian tube cancer

Studies how itraconazole changes the body's handling of AZD5335 in adults with gynecologic cancers.

Key facts

Who runs it
AstraZeneca
Where
Lisbon, PortugalSee the siteAlso in 3 other countries, 7 sites
Registry title
Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Status
Recruiting
Phase
Phase 1
People taking part
32 people, planned
Started
26 Jan 2026
Expected to end
15 Oct 2027
Type of study
Interventional
Treatments tested
  • AZD5335
  • Itraconazole
Record updated
29 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women with relapsed, platinum-resistant, high-grade ovarian, primary peritoneal or fallopian tube cancer who have already had platinum chemotherapy.

Age
18 years or older
Sex
Women only
Disease stage
Relapsed, platinum-resistant, high-grade epithelial ovarian, primary peritoneal or fallopian tube cancer. The cancer got worse on or within 6 months after the last platinum dose.
Earlier treatment
At least 1 earlier line of platinum-containing chemotherapy. Earlier bevacizumab and/or PARP inhibitors according to local guidelines, unless not able to take them.

Main reasons for not taking part

  • Spinal cord compression or past leptomeningeal carcinomatosis
  • Unresolved side effects of Grade 2 or higher from earlier therapy
  • Past non-infectious interstitial lung disease or pneumonitis that needed steroids or extra oxygen
  • Uncontrolled other illness within 12 months before screening
  • Any other reason not to receive itraconazole

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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

Where in Portugal

Also in 3 other countries, 7 sites

  • Start Research Portugal Unipessoal Lda.Lisbon, PortugalTaking people

About the trial

What the trial wants to find out

The purpose of this study is to assess the effect of itraconazole on the pharmacokinetics (PK) of AZ14170132.

The group in the trial

  • AZD5335/AZD5335 + ItraconazoleTreatment being tested

    In Part A, participants will receive AZD5335 alone as an intravenous (IV) infusion, and in combination with oral itraconazole, every 3 weeks (Q3W) from cycle 1 to cycle 3. In Part B, participants will receive AZD5335 as an IV infusion Q3W, from Day 1 of Cycle 4 until progression, unacceptable toxicity or any other specified criteria for discontinuation occurs.

    Treatment: AZD5335 and Itraconazole

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests how itraconazole affects AZD5335 in ovarian, peritoneal, or fallopian tube cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
29 September 2026