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Small Molecule Inhibitor
AND019 for Breast Cancer
Phase 1
Recruiting
Research Sponsored by Kind Pharmaceuticals LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological or cytological confirmation of advanced or metastatic ER+/HER2- breast cancer women who failed standard therapy or for which no standard therapy exists
ECOG score 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from treatment start date until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Awards & highlights
Study Summary
This trial will study the effects of a new drug, AND019, on women with breast cancer that has spread. They will be looking at how safe it is, how the body processes it, and if it has any effect on the tumor.
Who is the study for?
This trial is for postmenopausal women with advanced or metastatic ER+/HER2- breast cancer who have failed standard therapy or have no standard options left. They should be relatively healthy (ECOG score 0-1), have a life expectancy of at least 3 months, and must not have had more than one chemotherapy for advanced breast cancer.Check my eligibility
What is being tested?
AND019 PO QD is being tested to see how safe it is, how the body processes it, and if it works against certain types of breast cancer. This study includes increasing doses to find the right amount and will also look at its effects on tumor activity in participants.See study design
What are the potential side effects?
Specific side effects are not listed here, but generally, this type of trial looks out for any new symptoms that could range from mild discomforts like nausea to more serious conditions affecting organ function which would be monitored closely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is ER+ and HER2-, and standard treatments haven't worked.
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I am fully active or can carry out light work.
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I have had only one chemotherapy treatment for advanced breast cancer.
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My cancer returned or worsened after endocrine therapy but I initially benefited from it.
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I am considered postmenopausal according to current guidelines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from treatment start date until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from treatment start date until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with adverse events by severity, according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
PK study of AND019
Secondary outcome measures
Clinical Benefit Rate
Determine the RP2D
Duration of Response
+1 moreOther outcome measures
PD study of AND019 in blood samples
Body tissue
Progression free survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: AND019 single dose escalation and expansionExperimental Treatment1 Intervention
Subjects will be administrated with AND019 capsule PO QD from 20 mg to 400 mg during Part 1, and 2 dose groups will be selected for dose expansion study
Find a Location
Who is running the clinical trial?
Kind Pharmaceuticals LLCLead Sponsor
8 Previous Clinical Trials
524 Total Patients Enrolled
Yusha Zhu, MD PhDStudy DirectorKind Pharmaceuticals LLC
3 Previous Clinical Trials
205 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with SERDs before.My cancer can be measured by scans and is suitable for a biopsy.I haven't had major surgery or significant injury in the last 4 weeks and have no planned surgeries.My cancer has spread to my brain.I have another cancer besides this one that is getting worse or needs treatment.My bone marrow and organs are functioning well.I haven't had any radiotherapy in the last 3 weeks (systemic) or 7 days (local).I cannot take pills or have serious digestion issues.I have an active infection and am on antibiotics or antivirals.I have HIV, syphilis, hepatitis B or C without effective treatment.My breast cancer is ER+ and HER2-, and standard treatments haven't worked.You have a history of using drugs in a harmful way.I am fully active or can carry out light work.I have had only one chemotherapy treatment for advanced breast cancer.My cancer returned or worsened after endocrine therapy but I initially benefited from it.I have not had chemotherapy in the last 3 weeks.I haven't used strong CYP3A inhibitors, inducers, or consumed grapefruit in the last 4 weeks.I have heart problems or a history of heart issues.I haven't had serious unhealable wounds, ulcers, or fractures in the last 4 weeks.You are unable to have blood drawn from your veins.I haven't taken any cancer treatments like hormone therapy, immunotherapy, or targeted therapy in the last 3 weeks.I am considered postmenopausal according to current guidelines.I still have significant side effects from past cancer treatments.
Research Study Groups:
This trial has the following groups:- Group 1: AND019 single dose escalation and expansion
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for participation in this trial currently available?
"Clinicaltrials.gov presents this clinical trial as not currently admitting new patients, with the original posting dated August 1st 2022 and the latest update occurring on July 19th 2022. However, there are an abundance of other studies that are actively welcoming participants at present - 2288 to be exact."
Answered by AI
Has AND019 PO QD been demonstrated to be innocuous for human use?
"Because AND019 PO QD is in its initial trial phase, there are limited data that could attest to its safety and efficacy. For this reason, our team at Power has placed it on the low-risk scale of 1."
Answered by AI
What is the ultimate goal of this experiment?
"This medical trial's primary endpoint spans from baseline to 12 weeks after the last dosage of medication (potentially up to 25 months). The efficacy will be judged based on DLT and MTD evaluation. Secondary outcomes include a duration of response, objective response rate, and clinical benefit rate."
Answered by AI
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