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Protein Kinase Inhibitor

Osimertinib for Lung Cancer

Phase 1

Waitlist Available

Led By Yasir Y Elamin

Research Sponsored by M.D. Anderson Cancer Center

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 at end of 4th cycle (1 cycle = 28 days)

Awards & highlights

Study Summary

This trial is testing two drugs, alisertib and sapanisertib, to see if they can stop the growth of EGFR mutated non-small cell lung cancer when used with osimertinib.

Eligible Conditions

Lung Cancer
Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at end of 4th cycle (1 cycle = 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at end of 4th cycle (1 cycle = 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at end of 4th cycle (1 cycle = 28 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose-limiting toxicity (DLT)

Incidence of adverse events

RP2D of osimertinib and sapanisertib combination (Arm B)

+1 more

Secondary outcome measures

Objective response rate

Progression-free survival

Side effects data

From 2020 Phase 4 trial • 60 Patients • NCT03853551

10%

Blood creatine phosphokinase increased

10%

Fatigue

Decreased appetite

Diarrhoea

Cough

Mucosal inflammation

Rash

Pain in extremity

Constipation

Thrombocytopenia

Paronychia

Dyspnoea

Dengue fever

Disease progression

Cardio-respiratory arrest

Cataract

Mouth Ulceration

Deep Vein Thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (osimertinib, sapanisertib)Experimental Treatment2 Interventions

Patients receive osimertinib PO QD on days 1-28 and sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who develop progressive disease may crossover to Arm A.

Group II: Arm A (osimertinib, alisertib)Experimental Treatment2 Interventions

Patients receive osimertinib PO QD on days 1-28 and alisertib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who develop progressive disease may crossover to Arm B.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sapanisertib

2016

Completed Phase 2

~840

Osimertinib

2017

Completed Phase 4

~1010

Alisertib

2010

Completed Phase 2

~1140

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,965 Previous Clinical Trials

1,804,880 Total Patients Enrolled

Yasir Y ElaminPrincipal InvestigatorM.D. Anderson Cancer Center

5 Previous Clinical Trials

361 Total Patients Enrolled

Yasir Y Elamin, MDPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

12 Total Patients Enrolled

Frequently Asked Questions

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

Are there any other experiments that have utilized Osimertinib?

"Currently, there are 114 active investigations into Osimertinib with 17 of those in the third phase. The majority of these sites lie within Uniondale, New york; yet globally, 5198 medical centres are conducting clinical trials using this drug."

Answered by AI

Does Osimertinib pose any significant risk for individuals?

"Due to its Phase 1 status, current data empowers our team at Power to give Osimertinib a score of 1 in terms of safety. This phase is characterised by limited information supporting efficacy and the drug's protective properties."

Answered by AI

Is enrollment in this trial open to participants?

"The clinicaltrials.gov listing indicates that this trial is no longer recruiting patients, having first been posted on June 18th 2020 and last updated on July 31st 2022. Despite not being a viable option for those seeking to enroll in medical trials, there are currently 2,022 other studies actively taking partipants."

Answered by AI

How many participants are enrolled in this research program?

"This study is not presently accepting applications. According to the records on clinicaltrials.gov, it was first posted on June 18th 2020 and modified last on July 31st 2022; if you are searching for other studies, there are 1908 active trials seeking patients with carcinoma non-small-cell lung cancer and 114 that involve osimertinib recruitment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Osimertinib in Combination With Alisertib or Sapanisertib for the Treatment of Osimertinib-Resistant EGFR Mutant Stage IIIB or IV Non-Small Cell Lung Cancer

2020. "Osimertinib in Combination With Alisertib or Sapanisertib for the Treatment of Osimertinib-Resistant EGFR Mutant Stage IIIB or IV Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04479306.