AZD5305 hADME in Patients With Advanced Solid Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca
About this trial
This Phase I, open-label study aims to study to absolute bioavailability of Saruparib (AZD5305) and the absorption, distribution, metabolism and excretion (ADME) of \[14C\]-Saruparib in patients with advanced solid malignancies.
This will be done on an inpatient basis in 2 parts (single-dose oral administration with radiolabeled microtracer in Part A, single-dose IV radiolabeled administration in Part B) during which samples will be obtained of plasma, urine, feces and vomitus (where applicable).
Eligibility criteria
Qualifiers
Male or female ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), at the time of signing the ICF.
Histologically or cytologically documented, locally advanced or metastatic solid tumour, excluding lymphoma, for which standard therapy does not exist or has proven ineffective or intolerable.
ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to dosing.
Predicted life expectancy ≥ 12 weeks.
Disqualifiers
Participants with a history of MDS/AML or with features suggestive of MDS/AML (as determined by prior diagnostic investigation). Specific screening for MDS/AML is not required.
Participants with any known predisposition to bleeding
Any history of persisting severe cytopenia due to any cause
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of Saruparib.
Trial design
Treatments tested in this trial
- Saruparib (AZD5305)
- [14C]-AZD5305 microtracer
- [14C]-AZD5305 (therapeutic dose)
Treatment groups
8 Participants
are divided into 1 treatment groupSponsors and collaborators
AstraZeneca
Lead sponsor
Fortrea
Collaborator
Source ClinicalTrials.gov