About this trial
This study will take place across several countries. Participants in the study will know which treatment they are receiving (open-label), and participants will receive the treatments in the same order (fixed sequence). Participants will not be assigned to treatment groups by chance (non-randomized).
Part A
Part A includes:
Screening period: Tests and assessments to check whether you are eligible to take part in the study.
Treatment period: During Cycles 1, 2, and 3, you will receive AZD5335 together with itraconazole.
Follow-up visit: A visit after treatment to check your health and any side effects. (This visit does not apply if you continue into Part B.)
Part B
Part B includes:
Treatment period: Starting from Cycle 4, you will continue receiving study treatment as determined by the study doctor.
Safety follow-up period: After treatment ends, you will attend follow-up assessments so the study team can monitor your health and any ongoing side effects.
The purpose of this trial is to learn how safe AZD5335 is and if a drug called itraconazole changes how AZD5335 moves through the body over time in adults with ovarian, peritoneal, or fallopian tube cancer
Patient Profile
The key inclusion criteria include:
1. 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.
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Where’s this trial being run?
Mater Misericordiae University Hospital
Can I join this study / trial?
The first step we recommend is to talk to your doctor or the cancer trials team at your hospital. You can find contact details for cancer trials research units in Ireland here.
It’s also a good idea to print this page and bring it with you to your appointment. It can help guide the conversation and remind you of what to ask. You may also want to talk to your family or friends about your options, as they can offer support as you make decisions.
For more detailed information
Click HereQuestions?
Here’s a list of questions you may have for your doctor or local cancer research team.
QuestionsSummary Data
| Name: | D8991C00002: Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer |
|---|---|
| Number: | 26-35 |
| Full 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 |
| Principal Investigator: | Prof Austin Duffy (START, MMUH) |
|---|---|
| Type: | Industry Sponsored |
| Sponsor: | AstraZeneca |
| Recruitment Started: |
Global: Jan 26 Ireland: Feb 26 |
| Global Recruitment Target: | 34 |
|---|---|
| Ireland Recruitment Target: | 13 |