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Tyrosine Kinase Inhibitor

TPX-0131 for Non-Small Cell Lung Cancer

Phase 1

Waitlist Available

Research Sponsored by Turning Point Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 34 months

Awards & highlights

Study Summary

This trial is testing a new drug to treat patients with lung cancer that has progressed or spread, and who have a specific genetic change (ALK+). The trial will assess the safety and effectiveness of the drug.

Eligible Conditions

Non-Small Cell Lung Cancer
Solid Tumors
Metastatic Tumor
Gene Mutation

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 34 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 34 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 34 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Define the Recommended Phase 2 Dose

Incidence of first cycle dose-limiting toxicities (DLTs) of TPX-0131

Secondary outcome measures

Adverse events (AEs)

Trial Design

1Treatment groups

Experimental Treatment

Group I: TPX-0131Experimental Treatment1 Intervention

The Phase 1 part of the study will determine the safety, tolerability, PK, MTD, and RP2D of TPX-0131.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Turning Point Therapeutics, Inc.Lead Sponsor

9 Previous Clinical Trials

891 Total Patients Enrolled

Eric Park, M.D.Study DirectorTurning Point Therapeutics

1 Previous Clinical Trials

90 Total Patients Enrolled

Turning Point Therapeutics, MDStudy DirectorTurning Point Therapeutics

3 Previous Clinical Trials

125 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there multiple sites where this clinical trial is taking place?

"This ongoing clinical trial has 7 locations, which are: Virginia Cancer Specialists (Fairfax, VA), Massachusetts General Hospital (Boston, MA), University of Colorado Anschutz Medical Campus (Aurora, CO), and 6 other undisclosed centres."

Answered by AI

What are the goals that this research is trying to achieve?

"The primary objective of this study, as measured by the sponsor Turning Point Therapeutics, Inc., is to establish the recommended dosage of TPX-0131 over a 28 day period. Additionally, this clinical trial will also assess secondary outcomes including intracranial tumor response, duration of response (DOR), and patient-reported quality of life using the European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire."

Answered by AI

Are new participants being enrolled in this experiment at this time?

"No, this specific study is not looking for new patients at the moment, as per the information on clinicaltrials.gov. The trial was originally posted on 8/2/2021 and edited more recently on 11/7/2022. There are, however, 4500+ other studies that are recruiting patients right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of TPX-0131, a Novel Oral ALK Tyrosine Kinase Inhibitor, in Patients With ALK+ Advanced or Metastatic NSCLC

2021. "A Study of TPX-0131, a Novel Oral ALK Tyrosine Kinase Inhibitor, in Patients With ALK+ Advanced or Metastatic NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04849273.