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New treatment option for Locally Advanced or Metastatic Solid Tumor
Official title AZD5305 hADME in Patients With Advanced Solid Malignancies
ClinicalTrials.gov ID: NCT06713369
What this study is testing
What is Saruparib (AZD5305)?
Saruparib (AZD5305) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced or metastatic solid tumor.
Also referred to as Saruparib.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to dosing.
- Predicted life expectancy ≥ 12 weeks.
- Adequate organ and marrow function as defined in the protocol
You likely can't join if
- Participants with a history of MDS/AML or with features suggestive of MDS/AML (as determined by prior diagnostic investigation). Specific screening...
- 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...
- History of another primary malignancy, with some exceptions
- Persistent toxicities (CTCAE Grade ≥ 2), excluding alopecia, caused by previous anticancer therapy.
See the full eligibility criteria
- 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.
- Adequate organ and marrow function as defined in the protocol
- Willingness and ability to comply with study and follow-up procedures.
- Able and willing to stay in hospital for specified residential periods following administration of Saruparib/[14C]-Saruparib
- Regular bowel movements
- Body weight within normal range specified in protocol
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies Reproduction
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol
- 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...
- History of another primary malignancy, with some exceptions
- Persistent toxicities (CTCAE Grade ≥ 2), excluding alopecia, caused by previous anticancer therapy.
- Spinal cord compression or brain metastases for at least 4 weeks prior to start of study intervention unless asymptomatic and stable
- Abnormal cardiac function exclusions or cardiovascular disease
- History of arrhythmia
- Active HBV (positive HBsAg result) or HCV.
- Evidence of active and uncontrolled HIV infection.
- Active tuberculosis infection
- Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study.
- As judged by the investigator, any other evidence of diseases (such as severe or uncontrolled systemic diseases or active uncontrolled infections which, in the investigator's opinion, makes it undesirable for the...
- Any prior treatment with a PARP inhibitor or platinum chemotherapy.
- Other anticancer therapy (chemotherapy, immunotherapy, hormonal anticancer therapy, radiotherapy [except for palliative local radiotherapy]), biological therapy or other novel agent is not permitted until the last PK...
- Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation or to more than 30% of the bone marrow within 4 weeks before the first dose of study intervention
- Concomitant use of medications or herbal supplements known to be CYP3A4 strong and moderate inhibitors or inducers
- Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of Torsades de Pointes
- Participants who have participated in another absorption, distribution, metabolism, and excretion study within 1 year prior to screening.
- Participation in another clinical study with a study intervention administered in the last 3 months or 5 half-lives prior to dosing, whichever is longer.
- Participants with a known hypersensitivity to Saruparib or any of the excipients of the product.
- Participants who have been administered any amount of a [14C]-labelled compound within the last 12 months.
- Use of tobacco- or nicotine-containing products or alcohol may be exclusionary
- Poor peripheral venous access (venous access via a port will be permitted).
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
- Previous enrolment in the present study.
- For female participants only: currently pregnant (confirmed with positive pregnancy test) or planning to become pregnant, breast-feeding, or intending to donate/retrieve ova before 6 months after the last dose of...
The study team makes the final eligibility decision.
Where it's taking place
- Liverpool, United Kingdom
- Manchester, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Liverpool, United Kingdom; Manchester, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.