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Anti-tumor agent
ASTX295 for Solid Cancers
Phase 1 & 2
Waitlist Available
Research Sponsored by Astex Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Phase 2: eligible tumor types as follows: malignant pleural mesothelioma (MPM) (Cohort 1); Liposarcoma (well-differentiated (WD) , de- differentiated (DD), or mix), intimal sarcoma, and other sarcomas with human murine double minute 2 (MDM2) amplification (Cohort 2); Glioblastoma multiforme (GBM) and tumors with CDNK2A loss of function (LOF) excluding MPM, liposarcoma, intimal sarcoma, and uveal melanoma (UVM) (Cohort 3); any solid tumors with molecular feature that may confer sensitivity to ASTX295 (Cohort 4); Uveal melanoma (Cohort 5); Any cancer type with MDM2 amplification excluding MPM, sarcoma, and UVM(Cohort 6).
Have histologically or cytologically confirmed advanced solid tumors that are metastatic or unresectable and are refractory or have relapsed after treatment with standard available therapies or for whom standard life-prolonging measures are not available.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 1 year
Awards & highlights
Study Summary
This trial is testing a new drug, ASTX295, to see if it is safe and effective in treating people with certain types of cancer. The trial will have two parts, with the first part testing different doses of the drug to see what is safe and what works best.
Who is the study for?
Adults with advanced solid tumors that have not spread and are untreatable or have returned after standard therapy. They must be in fairly good health, able to perform daily activities (ECOG 0-2), and have normal organ function tests. Specific tumor types are eligible for different phases of the trial, all requiring a wild-type TP53 gene.Check my eligibility
What is being tested?
ASTX295 is being tested in patients with specific solid tumors containing the wild-type TP53 gene. The study has two parts: Phase 1 to find the right dose and see how safe it is, followed by Phase 2 to check its effectiveness against certain cancers.See study design
What are the potential side effects?
Potential side effects of ASTX295 aren't detailed here but may include typical reactions seen with cancer treatments such as fatigue, nausea, liver issues, or blood count changes based on similar drugs' profiles.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer type matches one of the specific categories listed for the trial.
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My cancer has spread, cannot be surgically removed, and does not respond to standard treatments.
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My cancer does not have TP53 mutations.
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I am 18 years old or older.
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I am able to get out of my bed or chair and move around.
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My kidney function tests are within the normal range.
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I have a tumor sample available for TP53 testing.
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My liver enzymes are within the required limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1a: Safety and tolerability of ASTX295 including determination of maximum tolerated dose (MTD), and/or recommended dose for expansion (RDE) to Phase 1b
Phase 1b: Recommended Phase 2 dose (RP2D) and regimen of ASTX295 to proceed to Phase 2
Phase 2: Disease control rate (DCR) in Cohort 1
+1 moreSecondary outcome measures
Pharmacokinetic (PK) profile of ASTX295 (area under the curve [AUC])
Pharmacokinetic (PK) profile of ASTX295 (elimination half-life [t½])
Pharmacokinetic (PK) profile of ASTX295 (maximum concentration [Cmax])
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: ASTX295Experimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Astex Pharmaceuticals, Inc.Lead Sponsor
95 Previous Clinical Trials
7,711 Total Patients Enrolled
Kim-Hein Dao, DO, PhDStudy DirectorAstex Pharmaceuticals, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer type matches one of the specific categories listed for the trial.My heart's pumping ability is below normal.I have advanced HIV or AIDS.I have a history or risk of heart disease.I do not have severe heart failure.I do not have unstable heart conditions.I haven't had cancer treatment within the specified time before starting the study drug.I do not have active hepatitis B or C, or it's under control with low viral load.My brain metastases are stable for 4 weeks and may or may not be on steroids.I do not have any severe illness or organ problems that could make the study unsafe for me.My cancer has spread, cannot be surgically removed, and does not respond to standard treatments.My cancer does not have TP53 mutations.I am 18 years old or older.I haven't taken any experimental drugs recently, and any side effects I had are now mild.I have been treated with an MDM2 antagonist before.I cannot or will not follow the oral medication rules for ASTX295.I have no active cancer other than the one being studied, except for low-risk cancers specified.I am able to get out of my bed or chair and move around.My liver is working well.I haven't had major surgery or radiation in the last 4 weeks.I am either male or female.I haven't had monoclonal antibodies, biologics, or immunotherapy in the last 4 weeks.I haven't had chemotherapy in the last 3 weeks and any side effects are mild or gone.I agree to have biopsies before and during treatment.My kidney function tests are within the normal range.I have a tumor sample available for TP53 testing.My liver enzymes are within the required limits.My cancer can be of any type for this trial phase.I am willing and able to follow the study's rules and sign the consent form.
Research Study Groups:
This trial has the following groups:- Group 1: ASTX295
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.
What are the anticipated results of this clinical experiment?
"According to Astex Pharmaceuticals, Inc., the key metric of this trial is Phase 1a: Safety and tolerability including MTD and RDE. Secondary outcomes being measured include PK profile (AUC) in both fed and fasted states as well as preliminary clinical activity assessed by Disease Control Rate (DCR) and Objective Response Rate (ORR). Data will be collected over a time period ranging from 6 months up to one year."
Answered by AI
Are participants currently being accepted into the experiment?
"Affirmative. The clinicaltrials.gov archive reveals that this research is presently recruiting subjects, having been first listed on July 11th 2019 and most recently updated on November 18th 2022. A total of 250 volunteers are required to be selected from 19 different sites."
Answered by AI
What is the current participant count of this scientific experiment?
"This medical trial necessitates the recruitment of 250 qualified patients. The Holden Comprehensive Cancer Center in Pennsylvania and Hoag Hospital in San Antonio, Texas are just two locations where those interested can enrol."
Answered by AI
Are there numerous Canadian sites administering this investigation?
"Holden Comprehensive Cancer Center in Philadelphia, Hoag Hospital in San Antonio, City of Hope Comprehensive Cancer Centre in Fairfax, and 16 other medical centres are recruiting patients for this clinical trial."
Answered by AI
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