Study of AZD5305 Alone and with Other Cancer Treatments in Patients with Advanced Solid Tumors
Sponsor: AstraZeneca
ClinicalTrials ID:NCT04644068
This clinical trial is testing a new drug, AZD5305, to see if it is safe and effective when used alone or with other cancer treatments in patients with advanced solid tumors.
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Program Overview
The purpose of this study is to find out if the experimental drug AZD5305, a PARP inhibitor, is safe and can help treat advanced solid tumors. The study will test AZD5305 both by itself and in combination with other cancer treatments to see how well it works and how patients tolerate it.
Description
This study is a Phase I/IIa trial, meaning it is in the early stages of testing. It is open-label, so both the researchers and participants know what treatment is being given. The study is being conducted at multiple centers and involves taking AZD5305 orally, either alone or with other cancer drugs, in patients with advanced solid tumors.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of advanced cancer suitable for the study treatment.
- Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
- Have a life expectancy of at least 12 weeks.
- Cancer must be progressing at the time of joining the study.
- Must have measurable disease as defined by specific criteria for different parts of the study.
- Must have adequate organ and bone marrow function as per the study protocol.
- For Part B, must provide a tumor sample if available, unless stated otherwise in a specific module.
For Part A:
- May have had one prior treatment with a PARP inhibitor.
For Part B:
- Must not have had prior treatment with a PARP inhibitor.
Exclusion Criteria
- Recent treatment with certain chemotherapy drugs or investigational agents.
- Use of medications or supplements that affect liver enzymes or heart rhythm.
- Use of high-dose steroids.
- Recent major surgery or radiation therapy.
- History of severe blood cell deficiencies.
- Untreated or unstable brain or spinal cord cancer spread.
- Bleeding disorders or recent serious bleeding events.
- Certain heart conditions or recent heart events.
- Blood disorders like myelodysplastic syndrome or acute myeloid leukemia.
- Severe digestive issues that affect drug absorption.
- Allergies to the study drug or its ingredients.
- Other cancers that could interfere with the study.
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