The purpose of this study is to assess the effect of itraconazole on the pharmacokinetics (PK) of AZ14170132.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
AZD5335 will be administered as IV infusion.
Itraconazole capsule will be administered orally.
Research Site
Batumi, Georgia
NOT_YET_RECRUITINGResearch Site
Tbilisi, Georgia
NOT_YET_RECRUITINGResearch Site
Tbilisi, Georgia
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.
Time frame: 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.
Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Maximum plasma drug concentration (Cmax)
Cmax of AZ14170132 will be assessed.
Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Area under curve from time 0 to time 17 days (AUC0-17days)
AUC0-17days of AZ14170132 will be assessed.
Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Minimum plasma drug concentration (Cmin)
Cmin of AZ14170132 will be assessed.
Time frame: 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)
AUC0-t of AZ14170132 will be assessed.
Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Terminal elimination (lambda_z)
lambda\_z of AZ14170132 will be assessed.
Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Half life (t1/2)
t1/2 of AZ14170132 will be assessed.
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Research Site
Dublin, Ireland
RECRUITINGResearch Site
Lisbon, Portugal
RECRUITINGResearch Site
Barcelona, Spain
RECRUITINGResearch Site
Logroño, Spain
RECRUITINGResearch Site
Madrid, Spain
RECRUITINGResearch Site
Madrid, Spain
RECRUITINGTime frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Time to maximum observed concentration (tmax)
tmax of AZ14170132 will be assessed.
Time frame: Cycle 2 and Cycle 3 (each cycle is of 21 days)
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
The safety and tolerability of AZD5335 alone and in combination with itraconazole will be assessed.
Time frame: Part A: up to 121 days; Part B: up to 365 days post last participant first dose
Objective response rate (ORR)
The ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR), with the denominator defined as the number of participants in the response evaluable set.
Time frame: Part A: up to 121 days; Part B: up to 365 days post last participant first dose
Duration of response (DoR)
The DoR is defined as the time from the date of first documented objective response (which is subsequently confirmed) until date of first documented disease progression or death (by any cause in the absence of disease progression).
Time frame: Part A: up to 121 days; Part B: up to 365 days post last participant first dose
Progression-free Survival (PFS)
The PFS is defined as the time from the start of treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy prior to progression.
Time frame: From Day 1 until until disease progression or death (up to 2 years)