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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
Other protocol-defined inclusion criteria may apply.
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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Find a Location

Who is running the clinical trial?

Kura Oncology, Inc.Lead Sponsor
15 Previous Clinical Trials
1,522 Total Patients Enrolled

Frequently Asked Questions

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

Has the Escalation Cohort achieved regulatory acceptance from the FDA?

"Due to the limited amount of evidence available, Escalation Cohort was ranked a 1 in terms of safety. This is because it is currently undergoing Phase 1 trials which means efficacy and safety have yet to be established."

Answered by AI

Is this trial presently admitting participants?

"Affirmative, according to the clinicaltrials.gov records this experimental research is currently recruiting patients. The project was initially made available on February 1st 2023 and has been recently updated on January 11th 2023. This investigation requires 50 participants from two unique locations."

Answered by AI

To what extent is this clinical trial being populated by volunteers?

"Affirmative, the records on clinicaltrials.gov demonstrate that recruitment for this medical trial is ongoing. The study was initially shared to the public on February 1st 2023 and has since been updated as recent as January 11th of the same year. It aims to enroll 50 individuals between 2 locations."

Answered by AI

Could you please elucidate the primary aims of this investigation?

"According to the research data from Kura Oncology, Inc., the primary goal of this clinical trial is to assess the safety profile of DLT over a 28-day period. Besides that main outcome measure, secondary objectives such as exploring tipifarnib and osimertinib's pharmacokinetic properties, evaluating circulating tumor DNA alteration prevalence in both ctDNA positive and negative patients and measuring clearance rates for those who were ctDNA positive at baseline are being investigated."

Answered by AI
~0 spots leftby Jul 2027