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

Sponsor
AstraZeneca
Study ID
NCT07402915
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AZD5335 — DRUG
    AZD5335 will be administered as IV infusion.
  • Itraconazole — DRUG
    Itraconazole capsule will be administered orally.

Study Details

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

Key Dates

First listed
Feb 11, 2026
Start date
Jan 26, 2026
Status verified
Jul 2026
Primary completion
Oct 15, 2027
Completion
Oct 15, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: AZD5335/AZD5335 + Itraconazole
    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.

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) ]

Central Contacts

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