Fallopian Tube CancerPhase 1NCT07402915
Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
A Phase 1 study testing AZD5335 and Itraconazole in people with Fallopian Tube Cancer and Ovarian Cancer, run by AstraZeneca at 9 sites in 4 countries.
Trial summary
The purpose of this study is to assess the effect of itraconazole on the pharmacokinetics (PK) of AZ14170132. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal
- What is being tested?
- AZD5335 and Itraconazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 26 Jan 2026to 15 Oct 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
9 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
9 sites in 4 countries
Spain4 sites, 4 recruiting
- Recruiting
Research Site
Barcelona, 08023
- Recruiting
Research Site
Logroño, 26006
- Recruiting
Research Site
Madrid, 28040
- Recruiting
Research Site
Madrid, 28050
Georgia3 sites
- Withdrawn
Research Site
Batumi, 6010
- Withdrawn
Research Site
Tbilisi, 0114
- Withdrawn
Research Site
Tbilisi, 112
About this study
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
The purpose of this study is to assess the effect of itraconazole on the pharmacokinetics (PK) of AZ14170132.
Read the detailed description
This is a non-randomized, open-label, fixed sequence study to be conducted at multiple study centers.
The study will consist of 2 parts:
Part A of the study will comprise of:
- Screening period
- Treatment period: The treatment period will comprise of Cycles 1, 2 and 3 where the participants will receive AZD5335 along with itraconazole
- Follow-up visit (not applicable for participants involved in Part B)
Part B of the study will comprise of:
- Treatment period: Cycle 4 and onwards
- Safety Follow-up period
- Conditions
- Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal
- Being tested
- AZD5335, Itraconazole
- Keywords
- CYP3A inhibitor, TOP1 inhibitor payload
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5335Drug
Also called AZ14170132
AZD5335 will be administered as IV infusion.
ItraconazoleDrug
Itraconazole capsule will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| AZD5335/AZD5335 + Itraconazole | Experimental | 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. Receives: Drug: AZD5335; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve from time 0 to time 17 days (AUC0-17days)
The effect of itraconazole on the pharmacokinetics (PK) of AZ14170132 will be assessed.
Measured: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Maximum plasma drug concentration (Cmax)
The effect of itraconazole on the PK of AZ14170132 will be assessed.
Measured: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Secondary outcomes (11)
Maximum plasma drug concentration (Cmax)
Cmax of AZ14170132 will be assessed.
Measured: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Area under curve from time 0 to time 17 days (AUC0-17days)
AUC0-17days of AZ14170132 will be assessed.
Measured: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Minimum plasma drug concentration (Cmin)
Cmin of AZ14170132 will be assessed.
Measured: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Area under curve from time 0 to the time of last measurable concentration (AUC0-t)
AUC0-t of AZ14170132 will be assessed.
Measured: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Terminal elimination (lambda_z)
lambda_z of AZ14170132 will be assessed.
Measured: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Half life (t1/2)
t1/2 of AZ14170132 will be assessed.
Measured: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Time to maximum observed concentration (tmax)
tmax of AZ14170132 will be assessed.
Measured: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
The safety and tolerability of AZD5335 alone and in combination with itraconazole will be assessed.
Measured: Part A: up to 121 days; Part B: up to 365 days post last participant first dose
Objective response rate (ORR)
The ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR), with the denominator defined as the number of participants in the response evaluable set.
Measured: Part A: up to 121 days; Part B: up to 365 days post last participant first dose
Duration of response (DoR)
The DoR is defined as the time from the date of first documented objective response (which is subsequently confirmed) until date of first documented disease progression or death (by any cause in the absence of disease progression).
Measured: Part A: up to 121 days; Part B: up to 365 days post last participant first dose
Progression-free Survival (PFS)
The PFS is defined as the time from the start of treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy prior to progression.
Measured: From Day 1 until until disease progression or death (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start26 Jan 2026
- Primary completion15 Oct 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallopian Tube CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402915
- Sponsor's protocol ID
- D8991C00002
- Other IDs
- EU CT
- Status last verified
- Aug 2026
- First submitted
- 23 Jan 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07402915
- Acronym / sponsor ID
- D8991C00002
- Conditions
- Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal
- Keywords
- CYP3A inhibitor, TOP1 inhibitor payload
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effect of itraconazole on the pharmacokinetics (PK) of AZ14170132.
Detailed description
This is a non-randomized, open-label, fixed sequence study to be conducted at multiple study centers.
The study will consist of 2 parts:
Part A of the study will comprise of:
- Screening period
- Treatment period: The treatment period will comprise of Cycles 1, 2 and 3 where the participants will receive AZD5335 along with itraconazole
- Follow-up visit (not applicable for participants involved in Part B)
Part B of the study will comprise of:
- Treatment period: Cycle 4 and onwards
- Safety Follow-up period
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD5335/AZD5335 + Itraconazole | Experimental | Drug: AZD5335, Drug: ItraconazoleIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD5335Also: AZ14170132AZD5335 will be administered as IV infusion. | Drug | AZD5335/AZD5335 + Itraconazole |
| ItraconazoleItraconazole capsule will be administered orally. | Drug | AZD5335/AZD5335 + Itraconazole |
Primary outcome
Area under curve from time 0 to time 17 days (AUC0-17days)
Time frame: 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)
Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
The effect of itraconazole on the PK of AZ14170132 will be assessed.
11 secondary outcomes
Maximum plasma drug concentration (Cmax)
Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Area under curve from time 0 to time 17 days (AUC0-17days)
Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Minimum plasma drug concentration (Cmin)
Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Area under curve from time 0 to the time of last measurable concentration (AUC0-t)
Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Terminal elimination (lambda_z)
Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Half life (t1/2)
Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Time to maximum observed concentration (tmax)
Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Part A: up to 121 days; Part B: up to 365 days post last participant first dose
Objective response rate (ORR)
Time frame: Part A: up to 121 days; Part B: up to 365 days post last participant first dose
Duration of response (DoR)
Time frame: Part A: up to 121 days; Part B: up to 365 days post last participant first dose
Progression-free Survival (PFS)
Time frame: From Day 1 until until disease progression or death (up to 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD5335 and Itraconazole in people with Fallopian Tube Cancer and Ovarian Cancer, run by AstraZeneca at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain, Georgia, Ireland, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under curve from time 0 to time 17 days (AUC0-17days) (time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.