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Hypomethylation Agent
ASTX727 + Paclitaxel + Pembrolizumab for Breast Cancer
Phase 1
Recruiting
Led By Roberto A Leon-Ferre
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years
Patients with evidence of chronic hepatitis B virus (HBV) infection must have undetectable viral load on suppressive therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial tests a new combo of drugs to treat advanced triple-negative breast cancer.
Who is the study for?
Adults with metastatic triple-negative breast cancer can join this trial. They should have normal organ function, no severe neuropathy, and be in good physical condition. Prior treatments for cancer are okay if they've recovered from the side effects. People with certain viral infections must have them under control.Check my eligibility
What is being tested?
The trial is testing ASTX727 (a combo of decitabine and cedazuridine) added to standard chemotherapy (paclitaxel) and immunotherapy (pembrolizumab). It aims to find a safe dose that might help shrink or stabilize cancer better than the usual treatment alone.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation, nerve damage from paclitaxel, blood cell count changes due to decitabine, and gastrointestinal issues affecting medication absorption.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have chronic hepatitis B but it's under control with medication.
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I am mostly self-sufficient and can carry out daily activities.
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My kidney function, measured by creatinine clearance, is adequate.
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My heart condition allows me to perform daily activities with slight limitations.
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I have not received any live vaccines in the last 30 days.
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My breast cancer is triple-negative, cannot be removed by surgery, and has spread.
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I had hepatitis C but am now cured or have no detectable virus while on treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximally tolerated dose (MTD) of ASTX727 in combination with paclitaxel and pembrolizumab (MK-3475) (Dose Finding Phase)
Safety profile of ASTX727 in combination with paclitaxel and pembrolizumab (MK-3475) (Dose Finding Phase)
Secondary outcome measures
Duration of response (Dose Expansion Phase)
Overall survival (Dose Expansion Phase)
Progression-free survival (Dose Expansion Phase)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ASTX727, paclitaxel, pembrolizumab)Experimental Treatment7 Interventions
Patients receive ASTX727 PO on days 1-4, paclitaxel IV over 1 hour on days 1, 8, and 15, and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo collection of blood samples and CT and/or MRI throughout the trial. Patients in the dose-expansion phase also undergo a tumor biopsy during screening and day 1 of the treatment cycle 2 of the study. Patients will be followed every 3 months for 2 years after treatment and then every 6 months for an additional 3 years or until death, whichever occurs first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Biopsy
2014
Completed Phase 4
~1090
Pembrolizumab
2017
Completed Phase 2
~2010
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,666 Previous Clinical Trials
40,925,981 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Roberto A Leon-FerrePrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
1 Previous Clinical Trials
38 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking any other experimental medications.I have been treated for an autoimmune disease in the last 2 years.I am 18 years old or older.I have an active case of tuberculosis.I have another cancer that is getting worse or needs treatment.I agree to provide tumor biopsies and my cancer can be measured by scans.I have no uncontrolled illnesses or a history of lung inflammation treated with steroids.I've had a severe allergic reaction to paclitaxel or similar drugs.Your AST and ALT levels should not be more than three times the normal limit.I have an immune system disorder or have been taking high doses of steroids or other immune-weakening medicines recently.Your platelet count should be at least 100,000 per cubic millimeter within 14 days of joining the study.I am allergic to medications similar to ASTX727, pembrolizumab, or paclitaxel.I have a stomach or intestine problem that affects how I absorb pills.I haven't had blood products or certain medications in the last 4 weeks.I have chronic hepatitis B but it's under control with medication.My previous nerve damage symptoms have mostly gone away.I am mostly self-sufficient and can carry out daily activities.My kidney function, measured by creatinine clearance, is adequate.I can understand and am willing to sign the consent form myself or have someone legally allowed to do it for me.My heart condition allows me to perform daily activities with slight limitations.I have not received any live vaccines in the last 30 days.Your hemoglobin level is at least 9 g/dL or 5.6 mmol/L within the last 14 days.Your bilirubin levels must be within a certain range as measured by a blood test taken within 14 days before starting the trial.My brain cancer has been treated, isn't growing, and I have cancer elsewhere in my body.I have had cancer before, but it won't affect this treatment's safety or results.My breast cancer is triple-negative, cannot be removed by surgery, and has spread.Your absolute neutrophil count is at least 1500 per cubic millimeter within 14 days of signing up for the study.I have recovered from side effects of previous cancer treatments, except for hair loss.I have received multiple treatments for my cancer after it spread.I had hepatitis C but am now cured or have no detectable virus while on treatment.I have had a solid organ or bone marrow transplant.I am HIV-positive, on treatment, and my viral load is undetectable.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ASTX727, paclitaxel, pembrolizumab)
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 vacancies remaining in this research project?
"Affirmative, the information posted on clinicaltrials.gov confirms that this medical study is in its recruitment phase. This trial was first announced on March 2nd 2023 and has been recently updated as of March 15th 2023. The investigators are looking for a total of 24 volunteers across 1 centre."
Answered by AI
Has the combination of ASTX727, paclitaxel, and pembrolizumab been granted permission to be distributed commercially by the FDA?
"Given the Phase 1 nature of this study, our team has cautiously assigned Treatment (ASTX727, paclitaxel, pembrolizumab) a safety score of 1. This is due to limited data supporting both efficacy and patient well-being."
Answered by AI
To what extent is participation in this trial limited?
"Affirmative. The clinicaltrials.gov page demonstrates that this medical trial, initially posted on March 2nd 2023, is actively seeking individuals to join the study. In total they require 24 participants from a single site."
Answered by AI
What are the projected outcomes of this research endeavor?
"The primary assessment of this clinical trial, which takes place over the course of 28 days, is to evaluate the safety profile of ASTX727 when administered in combination with paclitaxel and pembrolizumab (MK-3475). Secondary objectives include evaluating tolerability, determined by assessing maximum grade for each adverse event as well as severity rate; determining tumor response rate via immune modified Response Evaluation Criteria in Solid Tumors criteria; and estimating duration of response using Kaplan-Meier methodology."
Answered by AI
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