A Phase 1 interventional study of AZD5335 and Itraconazole in Fallopian Tube Cancer, Ovarian Cancer and Primary Peritoneal, sponsored by AstraZeneca. Recruiting at 9 sites in 4 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
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Among 10 studies in Fallopian Tube Neoplasms by AstraZeneca — 4 open to participants now, 4 under way, 2 of them phase 3. Fallopian Tube Neoplasms · AstraZeneca.
Among the 10 studies in Fallopian Tube Neoplasms by AstraZeneca, this one is one of 3 that started in 2026, is one of 2 in phase 1, and was the 8th registered.
835 studies on the registry are indexed under Fallopian Tube Neoplasms; 131 are open to participants now.
Browse Fallopian Tube Neoplasms studies →4 of the 10 studies in Fallopian Tube Neoplasms by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in United States, Australia, Brazil and 10 more countries
Ages 18+ · Women only
AstraZeneca · Sites in United States, Argentina, Australia and 26 more countries
Ages 18+ · Women only
AstraZeneca · Sites in United States, Australia, Germany and 4 more countries
Ages 18–130
By country, each count listing its studies:
Of the 106 Fallopian Tube Neoplasms studies recruiting now, 88 (83%) set no upper age limit and 10 (9%) stop at 75 or younger; 6 take children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 2 · Phase 3 2
First in 2001; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 32 is below the median of 50 across 684 interventional studies indexed under Fallopian Tube Neoplasms.
Median enrollment 600 across the 5 interventional studies, 390 across the 4 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
1 of the studies in Fallopian Tube Neoplasms by AstraZeneca that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07402915AstraZenecaDrug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer | 2027-10-15 |
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Among the 10 studies in Fallopian Tube Neoplasms by AstraZeneca, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to assess the effect of itraconazole on the pharmacokinetics (PK) of AZ14170132.
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:
Part B of the study will comprise of:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: AZD5335 · Drug: Itraconazole
AZD5335 will be administered as IV infusion.
Also known as: AZ14170132
Itraconazole capsule will be administered orally.
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.
Time frame: 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.
Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Maximum plasma drug concentration (Cmax)
Cmax of AZ14170132 will be assessed.
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)
AUC0-17days of AZ14170132 will be assessed.
Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Minimum plasma drug concentration (Cmin)
Cmin of AZ14170132 will be assessed.
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)
AUC0-t of AZ14170132 will be assessed.
Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Terminal elimination (lambda_z)
lambda\_z of AZ14170132 will be assessed.
Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Half life (t1/2)
t1/2 of AZ14170132 will be assessed.
Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Time to maximum observed concentration (tmax)
tmax of AZ14170132 will be assessed.
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)
The safety and tolerability of AZD5335 alone and in combination with itraconazole will be assessed.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: From Day 1 until until disease progression or death (up to 2 years)
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Plan to share: 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.
Time frame: AstraZeneca will meet or exceed data availability as per the commitment a made to the EFPIA PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Oct 2027, 20 months after the start.
Of 31 industry-sponsored phase 1 interventional studies under Fallopian Tube Neoplasms, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 57. This study's planned 20 months is below that.
Counting every sponsor, half of 96 studies reached it within 54 months; a quarter within 36 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Torvutatug samrotecan