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

AstraZeneca

Status and phase: Enrolling; Phase 1

Conditions: Primary Peritoneal; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Drug: Itraconazole; Drug: AZD5335

Study type: Interventional

Funder types: Industry

Identifiers

NCT07402915

D8991C00002

EU CT (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 24 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 1 patient group

AZD5335/AZD5335 + Itraconazole

Experimental group

Description:

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.

Treatment:

Drug: AZD5335

Drug: Itraconazole