ASTX029 for Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Southern California Norris Comprehensive Cancer Center Site#114, Los Angeles, CASolid TumorsASTX029 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Solid Tumors, Adult

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 11 Secondary · Reporting Duration: Baseline to measured progressive disease or start of new anticancer therapy, through study completion, an average of 6 months to 1 year

Year 1
Efficacy (Phase 2) - Response Evaluation Criteria in Solid Tumors using RECIST v1.1
Efficacy - DCR
Efficacy - DOR
Efficacy - OS
Efficacy - PFS
Day 1
Pharmacokinetic profile of ASTX029 - AUC
Pharmacokinetic profile of ASTX029 - Cmax
Pharmacokinetic profile of ASTX029 - Cmin
Pharmacokinetic profile of ASTX029 - Half-life
Pharmacokinetic profile of ASTX029 - Metabolites
Pharmacokinetic profile of ASTX029 - Tmax
Day 8
Target engagement in tumor tissues - pRSK
Day 21
Safety (Phase 1) - Dose-limiting toxicities including incidence of Treatment-Emergent Adverse Events

Trial Safety

Safety Progress

1 of 3

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Trial Design

3 Treatment Groups

Phase 1 Regimen 1
1 of 3
Phase 1 Regimen 2
1 of 3
Phase 2
1 of 3

Experimental Treatment

300 Total Participants · 3 Treatment Groups

Primary Treatment: ASTX029 · No Placebo Group · Phase 1 & 2

Phase 1 Regimen 1
Drug
Experimental Group · 1 Intervention: ASTX029 · Intervention Types: Drug
Phase 1 Regimen 2
Drug
Experimental Group · 1 Intervention: ASTX029 · Intervention Types: Drug
Phase 2
Drug
Experimental Group · 1 Intervention: ASTX029 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ASTX029
2020
Completed Phase 1
~20

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to measured progressive disease or start of new anticancer therapy, through study completion, an average of 6 months to 1 year

Who is running the clinical trial?

Astex Pharmaceuticals, Inc.Lead Sponsor
92 Previous Clinical Trials
7,628 Total Patients Enrolled
Kim-Hien Dao, DO, PhDStudy DirectorAstex Pharmaceuticals, Inc.
2 Previous Clinical Trials
142 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 18 years old or older, regardless of gender.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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)." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.