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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects with histologically or cytologically confirmed advanced solid tumors that are metastatic or unresectable, who are refractory or have relapsed after treatment with available therapies or for whom standard life-prolonging measures or approved therapies are not available. In Phase 1 Part B and in the Phase 2 portion of the protocol, subjects must also have documented gene alterations in the MAPK pathway as detailed in the protocol
Eastern Cooperative Oncology Group performance status 0 to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to measured progressive disease or start of new anticancer therapy, through study completion, an average of 6 months to 1 year
Awards & highlights
Study Summary
This trial is testing a new drug to see if it's safe and effective for people with cancer who can't be treated with other available options.
Who is the study for?
Adults with advanced solid tumors that can't be removed or have spread, and who've tried all other treatments without success. They must be over 18, not pregnant or breastfeeding, willing to use contraception, and able to follow study procedures. Their cancer should have specific gene changes in the MAPK pathway and measurable by certain medical criteria.Check my eligibility
What is being tested?
ASTX029 is an oral drug being tested for safety and effectiveness in treating advanced solid tumors. This trial includes multiple phases where researchers will look at how the body processes the drug (pharmacokinetics), its effects on the body (pharmacodynamics), and any signs of tumor shrinkage.See study design
What are the potential side effects?
While detailed side effects are not provided here, common ones may include fatigue, nausea, diarrhea, liver issues reflected in blood tests, skin rash or itching. Serious side effects could involve heart problems or severe allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced, cannot be surgically removed, and has not responded to treatment. I also have specific gene changes.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to measured progressive disease or start of new anticancer therapy, through study completion, an average of 6 months to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to measured progressive disease or start of new anticancer therapy, through study completion, an average of 6 months to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy (Phase 2) - Response Evaluation Criteria in Solid Tumors using RECIST v1.1
Safety (Phase 1) - Dose-limiting toxicities including incidence of Treatment-Emergent Adverse Events
Secondary outcome measures
Efficacy - DCR
Efficacy - DOR
Efficacy - OS
+8 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Phase 2Experimental Treatment1 Intervention
ASTX029 at the RP2D of the selected dosing regimen identified in Phase 1 to subjects with tumors characterized by gene aberrations in the MAPK signal pathway that may confer sensitivity to ASTX029.
Group II: Phase 1 Regimen 2Experimental Treatment1 Intervention
Dose escalation and expansion:
Regimen 2: ASTX029 orally once a day for 14 days of each 21-day cycle.
Group III: Phase 1 Regimen 1Experimental Treatment1 Intervention
Dose escalation and expansion:
Regimen 1: ASTX029 orally once a day for 21 days of each 21-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ASTX029
2020
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Astex Pharmaceuticals, Inc.Lead Sponsor
95 Previous Clinical Trials
7,661 Total Patients Enrolled
Kim-Hien Dao, DO, PhDStudy DirectorAstex Pharmaceuticals, Inc.
2 Previous Clinical Trials
206 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of heart problems or am at risk for them.My cancer is advanced, cannot be surgically removed, and has not responded to treatment. I also have specific gene changes.I do not have any severe illnesses or conditions that could risk my safety or affect the study's results.I have not had cancer treatments within the restricted time frame.I have a known infectious disease or condition.I have or am at risk for eye conditions like RVO or CSR.My cancer can be biopsied.I am a man and will use contraception if my partner can have children.My organ functions are within normal ranges according to recent tests.My brain metastases have been treated and stable for 3 months.I am 18 years old or older.I can take care of myself and am up and about more than half of my waking hours.I have a significant mental health condition.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1 Regimen 1
- Group 2: Phase 1 Regimen 2
- Group 3: Phase 2
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.
How many centers are managing this research?
"This research is currently running at 19 sites, with locations ranging from Boston to Iowa City. To reduce the need for travel, it may be prudent to select a trial site close by."
Answered by AI
What is the primary aim of this research endeavor?
"Astex Pharmaceuticals, Inc., the study sponsor, outlines Safety (Phase 1) - Dose-limiting toxicities and Treatment Emergent Adverse Events as their primary outcome. This efficacy of this measure will be assessed over a 6 month to one year period, from Baseline to progressive disease or start of new anticancer therapy. Secondary outcomes include Efficacy - Duration of Response (DOR), Pharmacokinetic profile expressed in terms of Area Under the Time-Concentration Curve (AUC), and Progressive Free Survival (PFS)."
Answered by AI
Is enrollment still open for this experiment?
"Data from clinicaltrials.gov confirms that this medical experiment is in need of applicants. The trial was published initially on May 10th 2018 and underwent its most recent update on November 18th 2022."
Answered by AI
What is the magnitude of enrollment for this clinical assessment?
"This clinical trial necessitates 300 participants that meet the predetermined criteria for inclusion. Individuals have the chance to take part in this research from both Dana Farber Cancer Institute in Boston, Massachusetts and City of Hope Comprehensive Cancer Center located in Duarte, California."
Answered by AI
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