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ABL1/SRC TKI

Dasatinib for Non-Small Cell Lung Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Chul Kim

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 3 years

Awards & highlights

Study Summary

This trial is testing a combination of two drugs, dasatinib and osimertinib, to overcome resistance to EGFR-TKIs in patients with advanced non-small cell lung cancer with EGFR mutations.

Eligible Conditions

Non-Small Cell Lung Cancer
Epidermal Growth Factor Receptor Mutations

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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

Phase I : Number of patients with drug-related adverse events as assessed by CTCAEv4.0

Phase II : Number of patients that do not progress according to RECIST v1.1

Secondary outcome measures

Concentration of orimertinib in blood

Duration of response

Number of patients with treatment-related adverse events in the phase II study

+2 more

Side effects data

From 2022 Phase 2 trial • 54 Patients • NCT03023046

26%

Febrile neutropenia

17%

Sepsis

Mucositis oral

Upper gastrointestinal hemorrhage

Intracranial hemorrhage

Hypotension

Hypertension

Enterocolitis

Atrial fibrillation

Lower gastrointestinal hemorrhage

Delirium

Oropharyngeal pain

Gastric hemorrhage

Abdominal pain

Diarrhea

Fungemia

Typhlitis

Myocardial infarction

Fibrinogen decreased

Endophthalmitis

Multi-organ failure

Kidney infection

Peripheral motor neuropathy

Hypoxia

Sinus bradycardia

Edema limbs

Small intestinal obstruction

Aspiration

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Chemotherapy)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Phase I and Phase IIExperimental Treatment2 Interventions

Osimertinib (AZD9291) will be given at a 80mg/day dose taken orally across all levels of the dose escalation schedule. Dasatinib is taken orally and will be given at up to 4 dose levels. Level -2 (50 mg once daily), Level -1 (70 mg once daily), Level 1 (the starting dose - 50 mg twice daily), Level 2 (70 mg twice daily). Dose escalation will only include 2 dose levels (Levels 1 and 2); in addition there will be 2 dose levels below the starting dose level if dose reductions are necessary (Levels -1 and -2). There is no limit to the number of cycles a patient can receive. The phase II portion of the study will use the maximum tolerated dose of dasatinib determined in the phase I portion. Osimertinib (AZD9291) will be given at the same 80mg dose as the phase I portion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Osimertinib

2017

Completed Phase 4

~1010

Dasatinib

2012

Completed Phase 3

~2320

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hackensack Meridian HealthOTHER

131 Previous Clinical Trials

28,234 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,265 Previous Clinical Trials

288,605,272 Total Patients Enrolled

Chul KimLead Sponsor

Frequently Asked Questions

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

Are new participants still being allowed to join this trial?

"This study is not presently looking for new patients. The trial was first announced on October 1st, 2016 and has not been updated since January 9th, 2022. 2092 other trials are currently enrolling patients with egfr gene mutations and 170 Dasatinib trials are actively admitting participants."

Answered by AI

How many participants are enrolled in this trial?

"This particular trial is no longer seeking patients for recruitment. The study was first posted on October 1st, 2016 and was last updated on January 9th, 2022. For those still searching, there are 2092 and 170 clinical trials actively looking for patients with egfr gene mutations and Dasatinib respectively."

Answered by AI

What are Dasatinib's clinical trial results in other settings?

"Originally, dasatinib was studied in 2004 at Bronson Battle Creek. As of now, a total of 166 clinical trials have been completed. There are 170 live clinical trials at the moment, with a large concentration in Hackensack, New jersey."

Answered by AI

What are the researchers hoping to achieve with this experiment?

"The primary outcome of this study, to be conducted over the course of 9 months, is to Phase I : Number of patients with drug-related adverse events as assessed by CTCAEv4.0. Additionally, researchers will secondary outcomes including Duration of response and Concentration of orimertinib in blood. Finally, the study will also measure Overall survival."

Answered by AI

Recent research and studies

Frontiers in OncologyJournal

A Phase I Trial of Dasatinib and Osimertinib in TKI Naïve Patients with Advanced Egfr-mutant Non-small-cell Lung Cancer

Kim, Chul, Stephen V. Liu, Jennifer Crawford, Tisdrey Torres, Vincent Chen, Jillian Thompson, Ming Tan, Giuseppe Esposito, Deepa S. Subramaniam, and Giuseppe Giaccone. 2021. “A Phase I Trial of Dasatinib and Osimertinib in TKI Naïve Patients with Advanced Egfr-mutant Non-small-cell Lung Cancer”. Frontiers in Oncology. Frontiers Media SA. doi:10.3389/fonc.2021.728155.

clinicaltrials.govStudy

Dasatinib and Osimertinib (AZD9291) in Advanced Non-Small Cell Lung Cancer With EGFR Mutations

Chul Kim 2016. "Dasatinib and Osimertinib (AZD9291) in Advanced Non-Small Cell Lung Cancer With EGFR Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02954523.

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