Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

NCT07402915 | Recruiting Phase 1

• 2 other identifiers: D8991C00002EU CT
• Study Type: interventional
• Target: 24
• Locations: 4 countries
• Sites: 9

Brief Summary

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

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal

Keywords

CYP3A inhibitor; TOP1 inhibitor payload

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (11)

• Maximum plasma drug concentration (Cmax)

  Cycle 2 and Cycle 3 (each cycle is of 21 days)

• Area under curve from time 0 to time 17 days (AUC0-17days)

  Cycle 2 and Cycle 3 (each cycle is of 21 days)

• Minimum plasma drug concentration (Cmin)

  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)

  Cycle 2 and Cycle 3 (each cycle is of 21 days)

• Terminal elimination (lambda_z)

  Cycle 2 and Cycle 3 (each cycle is of 21 days)

Study Arms (1)

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.

Drug: AZD5335; Drug: Itraconazole

Interventions

AZD5335 DRUG

AZD5335 will be administered as IV infusion.

Also known as: AZ14170132

AZD5335/AZD5335 + Itraconazole

Itraconazole DRUG

Itraconazole capsule will be administered orally.

AZD5335/AZD5335 + Itraconazole

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (9)

Research Site

Batumi, 6010, Georgia

NOT YET RECRUITING

Research Site

Tbilisi, 0114, Georgia

NOT YET RECRUITING

Research Site

Tbilisi, 112, Georgia

NOT YET RECRUITING

Research Site

Dublin, D07 R2WY, Ireland

RECRUITING

Research Site

Lisbon, 1250-068, Portugal

RECRUITING

Research Site

Barcelona, 08023, Spain

RECRUITING

Research Site

Logroño, 26006, Spain

RECRUITING

Research Site

Madrid, 28040, Spain

RECRUITING

Research Site

Madrid, 28050, Spain

RECRUITING

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 11, 2026
• Study Start: January 26, 2026
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

PT (1); ES (4); GE (3); IE (1)