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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of azd8205 to death ( approx. 2 years )
Awards & highlights
Study Summary
This trial is testing a new drug, AZD8205, to see if it can shrink or slow the growth of certain types of cancer.
Who is the study for?
Adults (18+) with advanced or metastatic solid tumors, specifically breast cancer, ovarian cancer, bile duct cancer (cholangiocarcinoma), or endometrial cancer. Participants must have measurable disease and an ECOG performance status of 0-1. They should expect to live at least 12 weeks and have proper organ/marrow function. Prior treatments vary by sub-study group.Check my eligibility
What is being tested?
The trial is testing AZD8205 for patients with certain types of advanced cancers that have spread beyond the original site. It's a first-in-human study to see if this new compound can be effective in treating these conditions.See study design
What are the potential side effects?
While specific side effects for AZD8205 are not listed here, common ones for similar drugs include nausea, fatigue, risk of infection due to low blood cell counts, liver issues, and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can carry out all my daily activities without help.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose of azd8205 to death ( approx. 2 years )
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of azd8205 to death ( approx. 2 years )
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The number of patients with adverse events
The number of patients with changes from baseline laboratory findings, ECGs and vital signs
The number of patients with dose-limiting toxicity (DLT), as defined in the protocol.
+1 moreSecondary outcome measures
Disease Control Rate at 12 weeks (DCR-12)
Duration of response (DoR)
Immunogenicity of AZD8205.
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Sub-Study 1 AZD8205 MonotherapyExperimental Treatment1 Intervention
Sub-Study 1 has two parts:
Part A : The aim is to determine the safety, tolerability, Recommended Phase 2 Dose(RP2D), and/or the Maximum Tolerated Dose (MTD) of AZD8205.
Part B: The aim of dose expansion is to evaluate anti-tumor activity of AZD8205 as monotherapy in select solid tumors.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Targeted therapies for breast cancer, such as those being studied in the trial AZD8205, work by inhibiting specific molecular pathways that are crucial for tumor growth and metastasis. These therapies often target proteins or genes that are overexpressed or mutated in cancer cells, such as HER2, CDK4/6, and mTOR.
By blocking these pathways, targeted therapies can effectively slow down or stop the proliferation of cancer cells while minimizing damage to normal cells. This precision in treatment is particularly important for breast cancer patients as it can lead to better outcomes, fewer side effects, and a higher quality of life compared to traditional chemotherapy.
Breast Cancer Resistance to Cyclin-Dependent Kinases 4/6 Inhibitors: Intricacy of the Molecular Mechanisms.Pharmacokinetics, clinical indications, and resistance mechanisms in molecular targeted therapies in cancer.The emergence of targeted drugs in breast cancer to prevent resistance to endocrine treatment and chemotherapy.
Breast Cancer Resistance to Cyclin-Dependent Kinases 4/6 Inhibitors: Intricacy of the Molecular Mechanisms.Pharmacokinetics, clinical indications, and resistance mechanisms in molecular targeted therapies in cancer.The emergence of targeted drugs in breast cancer to prevent resistance to endocrine treatment and chemotherapy.
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,289 Previous Clinical Trials
288,619,950 Total Patients Enrolled
173 Trials studying Breast Cancer
1,246,097 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has returned or spread and I've had standard treatment or a trial is my best next step.I can carry out all my daily activities without help.I have advanced or recurrent breast, ovarian, bile duct, or endometrial cancer.I am 18 years old or older.My organs and bone marrow are working well.
Research Study Groups:
This trial has the following groups:- Group 1: Sub-Study 1 AZD8205 Monotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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