Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAstraZeneca
About this trial
The purpose of this study is to assess the effect of itraconazole on the pharmacokinetics (PK) of AZ14170132.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
AZD5335
DrugAZD5335 will be administered as IV infusion.
Itraconazole
DrugItraconazole capsule will be administered orally.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: AZD5335/AZD5335 + ItraconazoleExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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)2
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)Secondary outcomes
1
Maximum plasma drug concentration (Cmax)
Cmax of AZ14170132 will be assessed.
Time frame
Cycle 2 and Cycle 3 (each cycle is of 21 days)2
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)3
Minimum plasma drug concentration (Cmin)
Cmin of AZ14170132 will be assessed.
Time frame
Cycle 2 and Cycle 3 (each cycle is of 21 days)4
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)Sponsors and contacts
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Source ClinicalTrials.gov