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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
No Placebo-Only Group
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Define the Recommended Phase 2 Dose
Incidence of first cycle dose-limiting toxicities (DLTs) of TPX-0131
Secondary study objectives
Adverse events (AEs)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
Turning Point Therapeutics, Inc.Lead Sponsor
9 Previous Clinical Trials
866 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,568 Previous Clinical Trials
3,384,353 Total Patients Enrolled
Eric Park, M.D.Study DirectorTurning Point Therapeutics
1 Previous Clinical Trials
155 Total Patients Enrolled
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