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Tyrosine Kinase Inhibitor

Escalation Cohort for Non-Small Cell Lung Cancer

Phase 1
Waitlist Available
Research Sponsored by Kura Oncology, 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 assessed every 8 weeks for the first year and every 12 weeks thereafter up to end of study at approximately 2 years
Awards & highlights

Study Summary

This trial tests a new combination of drugs to treat advanced/metastatic lung cancer. It'll measure safety and effectiveness.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed every 8 weeks for the first year and every 12 weeks thereafter up to end of study at approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 8 weeks for the first year and every 12 weeks thereafter up to end of study at approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
For Dose Escalation characterize the safety of the combination DLTs will be listed for patients who complete the evaluation period for DLT
For Dose Escalation determine a safe and tolerable Phase 2 dose of tipifarnib when used in combination with osimertinib
For Dose Expansion characterize the safety profile of tipifarnib in combination with osimertinib as per NCI CTCAE v5.0 using descriptive statistics of adverse events
+1 more
Secondary outcome measures
To evaluate circulating tumor DNA (ctDNA) as an indicator or response in both ctDNA positive and negative patients by changes in genetic alterations
To evaluate circulating tumor DNA (ctDNA) clearance rates for patients positive at baseline
To evaluate circulating tumor DNA (ctDNA) time to detection changes associated with disease progression
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Expansion CohortExperimental Treatment2 Interventions
Adult participants with EGFR-mutated Non-Small Cell Lung Cancer
Group II: Escalation CohortExperimental Treatment2 Interventions
Adult participants with EGFR-mutated Non-Small Cell Lung Cancer
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tipifarnib
2000
Completed Phase 3
~710
Osimertinib
2017
Completed Phase 4
~1010

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Who is running the clinical trial?

Kura Oncology, Inc.Lead Sponsor
16 Previous Clinical Trials
1,544 Total Patients Enrolled
~0 spots leftby Jul 2027
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