Actively Recruiting
AZD5305 hADME in Patients With Advanced Solid Malignancies
Led by AstraZeneca · Updated on 2026-03-04
8
Participants Needed
2
Research Sites
78 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
F
Fortrea
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
AZD5305 hADME in Patients With Advanced Solid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at the time of consent
- Histologically or cytologically confirmed locally advanced or metastatic solid tumor excluding lymphoma
- ECOG performance status of 0 or 1 with no decline in 2 weeks before dosing
- Predicted life expectancy of at least 12 weeks
- Adequate organ and marrow function as defined in protocol
- Willing and able to comply with study and follow-up procedures
- Able and willing to stay hospitalized during specified residential periods after Saruparib administration
- Regular bowel movements
- Body weight within normal range specified in protocol
- Use of contraception consistent with local regulations
- Capable of providing signed informed consent including protocol compliance
You will not qualify if you...
- History or features suggestive of MDS/AML
- Known bleeding predisposition
- History of persistent severe cytopenia
- Refractory nausea, vomiting, chronic GI diseases, inability to swallow study drug, or major bowel resection affecting drug absorption/metabolism
- History of other primary malignancy with exceptions
- Persistent toxicities (CTCAE Grade ≥ 2) from prior anticancer therapy except alopecia
- Spinal cord compression or brain metastases within 4 weeks unless stable and asymptomatic
- Abnormal cardiac function or cardiovascular disease
- History of arrhythmia
- Active hepatitis B or C infection
- Active uncontrolled HIV infection
- Active tuberculosis infection
- Major surgery or significant trauma within 4 weeks before first dose or planned during study
- Any severe or uncontrolled systemic disease or infection deemed unsuitable by investigator
- Prior treatment with PARP inhibitor or platinum chemotherapy
- Other anticancer therapies not allowed until last PK sampling
- Recent palliative radiotherapy within 2 to 4 weeks depending on radiation field
- Use of strong/moderate CYP3A4 inhibitors or inducers
- Use of drugs known to affect QT interval with risk of Torsades de Pointes
- Participation in other ADME studies within 1 year
- Participation in other clinical studies with interventions within 3 months or 5 half-lives
- Known hypersensitivity to Saruparib or excipients
- Prior administration of any [14C]-labeled compound within 12 months
- Use of tobacco, nicotine products, or alcohol may exclude
- Poor peripheral venous access (port access allowed)
- Involvement in study planning or conduct
- Investigator judgment of likely noncompliance
- Previous enrollment in this study
- Female participants who are pregnant, breastfeeding, or planning pregnancy within 6 months after last dose of Saruparib
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Trial Site Locations
Total: 2 locations
1
Research Site
Liverpool, United Kingdom, L7 8YA
Actively Recruiting
2
Research Site
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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