Ignite Creation Date:
2025-12-18 @ 8:12 AM
Ignite Modification Date:
2025-12-23 @ 10:58 PM
Study NCT ID:
NCT05573724
Status:
None
Last Update Posted:
2024-06-18 00:00:00
First Post:
2022-10-07 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug-drug Interaction Study With AZD5305 and Itraconazole in Patients With Advanced Solid Malignancies
Sponsor:
None
Organization:
Study Overview
Official Title:
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:
None
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: