NCT05573724

Drug-drug Interaction Study With AZD5305 and Itraconazole in Patients With Advanced Solid Malignancies

A Non-randomized, Open-label, Fixed-sequence Phase I Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of AZD5305 in Patients With Advanced Solid Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, open-label, multi-centre drug-drug interaction (DDI) study of AZD5305 administered orally in patients with advanced solid tumours.

Detailed description

This study will comprise of two study parts, Part A and Part B. Part A of the study will assess the effect of multiple doses of Itraconazole on the single dose pharmacokinetic (PK) parameters of AZD5305 which will last up to 13 days. The patients will then continue into Part B and receive AZD5305 monotherapy at the discretion of the Investigator if the patients are deemed to still derive benefit from continued treatment until disease progression. The Part A of this study follows a non-randomized, open-label, 2-intervention design. Patients will receive the following two study interventions, AZD5305 and Itraconazole: a single oral dose of AZD5305 alone, multiple oral doses of itraconazole alone, and then a single oral dose of AZD5305 administered concomitantly with multiple doses of itraconazole. In Part B, the patients may continue the study with AZD5305 monotherapy after completing Part A of the study. AZD5305 monotherapy will continue until disease progression, unacceptable toxicities, initiation of alternative anticancer therapy, withdrawal of consent, or other reasons to discontinue study treatment occur.

Conditions

• Advanced Solid Malignancies

Interventions

Type	Name	Description
DRUG	AZD5305	In Part A, the participants will receive a single dose of AZD5305 on Day 1 and Day 7. In Part B, the participants will receive AZD5305 once daily.
DRUG	Itraconazole	In Part A, the participants will receive Itraconazole twice daily on Day 4 and once daily on Days 5-12

Timeline

• Start date: 2022-11-07
• Primary completion: 2023-04-17
• Completion: 2024-05-17
• First posted: 2022-10-10
• Last updated: 2024-06-18

Locations

2 sites across 2 countries: Moldova, Romania