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MEK Inhibitor

RO5126766 for Lung Cancer

Phase 1
Waitlist Available
Led By Gregory Riely, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prior treatment with chemotherapy
Measurable and/or evaluable disease (RECIST 1.1) indicator lesion not previously irradiated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing a new drug for people with lung cancer who have already tried other treatments. The goal is to see if it is safe and if it has any effect on the cancer.

Who is the study for?
This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has a KRAS mutation and who have previously been treated with PD-1 or PD-L1 inhibitors. Participants must be able to take oral medications, have a good performance status, and not have had certain treatments or conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing the safety of different doses of RO5126766 to see its effects on people with advanced KRAS-mutant lung cancer. It aims to determine the appropriate dosage by observing how patients respond to this experimental treatment after prior therapies.See study design
What are the potential side effects?
While specific side effects are not listed here, they typically include reactions related to drug tolerance levels such as fatigue, nausea, skin rash, and potential organ-specific inflammation depending on individual patient health factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have previously undergone chemotherapy.
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My cancer can be measured or seen on scans, and has not been treated with radiation.
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My lung cancer diagnosis was confirmed through tissue or cell testing.
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I am 18 years old or older.
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My cancer has a KRAS mutation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The maximum tolerated dose (MTD)
overall response rate (dose expansion)

Trial Design

1Treatment groups
Experimental Treatment
Group I: RO5126766 (CH5126766)Experimental Treatment1 Intervention
The study will begin with a standard 3+3 design. The study will enroll 3 patients at the previously identified MTD15 (4mg two times per week on days 1 and 4). The period of evaluation for dose limiting toxicity will be through completion of cycle 1. If ≤1 of the 3 initial patients at the proposed dose experience a DLT, then 3 additional patients will be enrolled for a total of 6 planned patients at that dose level. Otherwise, 3 patients will be enrolled at dose level -1. If ≤ 1 of these patients experience a DLT, then 3 additional patients will be enrolled at the same dose level. If more than 1 patient experiences a DLT in dose level -1, the study will be terminated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RO5126766
2008
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

Chugai Pharma USAIndustry Sponsor
8 Previous Clinical Trials
4,624 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,935 Previous Clinical Trials
588,840 Total Patients Enrolled
Dana-Farber Cancer InstituteOTHER
1,079 Previous Clinical Trials
340,933 Total Patients Enrolled

Frequently Asked Questions

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

Have any other experiments employed RO5126766 in the past?

"RO5126766 was originally trialled at The Christie NHS Foundation Trust in 2017. To this day, 1 trial has been completed and 3 additional trials are on-going, with multiple sites based out of the city of Miami."

Answered by AI

How widespread is the implementation of this experiment in U.S. hospitals?

"This trial is being carried out at Miami Cancer Institute in the city of Miami, Memorial Sloan Kettering Cancer Center located within New york City and Lehigh Valley Health Network situated close to Allentown Pennsylvania. There are a few other sites available as well."

Answered by AI

Can new patients still join this clinical experiment?

"Affirmative, based on the information hosted on clinicaltrials.gov, this particular medical study is not presently seeking patients to enrol in their trial. This research was initially advertised October 31st 2018 and has been revised most recently December 1st 2021; however, there are 1498 other options currently recruiting participants."

Answered by AI

Is this an unprecedented research project?

"Research into RO5126766 has been underway since 2017, when it was first studied in a clinical trial sponsored by Verastem, Inc. This initial investigation for the drug's safety warranted its Phase 1 approval and now there are 3 active trials being conducted across 7 cities spanning two nations."

Answered by AI

To what extent do the risks of RO5126766 outweigh its potential benefits?

"As RO5126766 is in its first phase of clinical trials, the available evidence regarding both safety and efficacy are limited. Therefore, Power assigned this medication a score of 1 on their scale."

Answered by AI

How many participants are currently contributing to this research experiment?

"Unfortunately, this trial is not presently accepting patients. It was first published on October 31st 2018 and concluded recruitment activities in December of 2021. There are currently 1495 clinical trials involving lung cancer and 3 for RO5126766 that have openings for participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
RO5126766 for Patients With Advanced KRAS-Mutant Lung Cancer
2018. "RO5126766 for Patients With Advanced KRAS-Mutant Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03681483.
~1 spots leftby Sep 2024
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