Osimertinib for Malignant Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Malignant Neoplasms+5 More
Osimertinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is to find out the benefits and side effects of two drugs, osimertinib and tegavivint, in treating patients with lung cancer that has spread to other places in the body.

Eligible Conditions
  • Malignant Neoplasms
  • Metastatic Lung Non-Small Cell Carcinoma
  • Stage IVA Lung Cancer AJCC v8
  • Stage IVB Lung Cancer AJCC v8

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 4 years

Baseline to 4 years
Positron-Emission Tomography
Year 4
Progression free survival
Year 4
Duration of response
Year 4
Overall survival
Day 22
Osimertinib (AZD9291) PK
Day 22
Tegavivint (BC2059) pharmacokinetics (PK)
Up to 28 days
Maximum tolerated dose
Up to 4 years
Circulating tumor deoxyribonucleic acid (ctDNA)
Heart rate
Β-catenin pathway activity

Trial Safety

Side Effects for

Single Arm
10%Blood creatine phosphokinase increased
10%Fatigue
8%Decreased appetite
8%Diarrhoea
8%Cough
7%Thrombocytopenia
7%Pain in extremity
7%Constipation
7%Rash
7%Mucosal inflammation
7%Paronychia
3%Dyspnoea
2%Cataract
2%Cardio-respiratory arrest
2%Deep Vein Thrombosis
2%Mouth Ulceration
2%Dengue fever
2%Disease progression
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT03853551) in the Single Arm ARM group. Side effects include: Blood creatine phosphokinase increased with 10%, Fatigue with 10%, Decreased appetite with 8%, Diarrhoea with 8%, Cough with 8%.

Trial Design

1 Treatment Group

Treatment (osimertinib, tegavivint)
1 of 1

Experimental Treatment

18 Total Participants · 1 Treatment Group

Primary Treatment: Osimertinib · No Placebo Group · Phase 1

Treatment (osimertinib, tegavivint)Experimental Group · 2 Interventions: Osimertinib, Tegavivint · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
FDA approved
Tegavivint
2018
Completed Phase 1
~30

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 years

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
284 Previous Clinical Trials
285,941 Total Patients Enrolled
Regan M Memmott, M.D., Ph.DPrincipal InvestigatorOhio State University Comprehensive Cancer Center
Regan M MemmottPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The presence of uncommon activating mutations in the EGFR gene is permitted if they co-occur with a common activating mutation
You have metastatic NSCLC.
You have measurable disease as defined by RECIST version 1.1 criteria.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 17th, 2021

Last Reviewed: November 22nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.