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| ID | Type | Description | Link |
|---|---|---|---|
| EU CT | Other Identifier | 2025-522731-34-00 |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD5335 | Drug | AZD5335 will be administered as IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Cycle 2 and Cycle 3 (each cycle is of 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma drug concentration (Cmax) | Cmax of AZ14170132 will be assessed. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Not yet recruiting | Batumi | 6010 | Georgia | ||
| Research Site |
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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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.
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.
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| Itraconazole | Drug | Itraconazole capsule will be administered orally. |
|
| Cycle 2 and Cycle 3 (each cycle is of 21 days) |
| Minimum plasma drug concentration (Cmin) | Cmin of AZ14170132 will be assessed. | 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. | Cycle 2 and Cycle 3 (each cycle is of 21 days) |
| Terminal elimination (lambda_z) | lambda_z of AZ14170132 will be assessed. | Cycle 2 and Cycle 3 (each cycle is of 21 days) |
| Half life (t1/2) | t1/2 of AZ14170132 will be assessed. | Cycle 2 and Cycle 3 (each cycle is of 21 days) |
| Time to maximum observed concentration (tmax) | tmax of AZ14170132 will be assessed. | 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. | 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. | 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). | 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. | From Day 1 until until disease progression or death (up to 2 years) |
| Not yet recruiting |
| Tbilisi |
| 0114 |
| Georgia |
| Research Site | Not yet recruiting | Tbilisi | 112 | Georgia |
| Research Site | Recruiting | Dublin | D07 R2WY | Ireland |
| Research Site | Recruiting | Lisbon | 1250-068 | Portugal |
| Research Site | Recruiting | Barcelona | 08023 | Spain |
| Research Site | Recruiting | LogroƱo | 26006 | Spain |
| Research Site | Recruiting | Madrid | 28040 | Spain |
| Research Site | Recruiting | Madrid | 28050 | Spain |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
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