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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group performance status of less than or equal to 1
Advanced or metastatic, unresectable tumors (other than patients with tumors of the brain or central nervous system) who have experienced disease progression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 years from date of the participants enrollment
Awards & highlights
Study Summary
This trial is testing a combination of drugs to treat tumors.
Who is the study for?
Adults with advanced solid tumors who can provide a tumor sample and consent, have a life expectancy over 12 weeks, measurable disease per RECIST 1.1, good performance status (ECOG ≤1), adequate organ function, and agree to use contraception can join. Exclusions include CNS metastasis, certain heart conditions, abnormal QT interval on ECG, active liver disease or infections like HIV/Hepatitis B/C.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: Lifirafenib (BGB-283) and Mirdametinib (PD-0325901) in adults with various types of advanced solid tumors. It's designed to assess safety and how the body processes these drugs.See study design
What are the potential side effects?
Potential side effects may include typical reactions seen with cancer treatments such as fatigue, nausea, skin rash or other allergic reactions. Specific risks related to Lifirafenib or Mirdametinib will be monitored based on their known profiles.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can carry out all my self-care but cannot do heavy physical work.
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My cancer has spread, cannot be surgically removed, and is getting worse.
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I am a male who is either vasectomized or agrees to use contraception.
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I can provide previous tumor samples or agree to a new biopsy.
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I am at least 18 years old or of legal age in my area to consent.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 2 years from date of the participants enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 years from date of the participants enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events and Serious Adverse Events
Objective response rate based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in participants with selected tumor types
The incidence of DLT events and treatment-emergent AEs (TEAEs)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Part B: ExpansionExperimental Treatment2 Interventions
Approximately 20 participants with NRAS mutated solid tumors will be enrolled
Group II: Part A: Dose Escalation/Dose finding Dose Level Cohorts ranging in dose levels and dose regimens.Experimental Treatment2 Interventions
Combination doses of, Mirdametinib at once a day and lifirafenib at once a day And Mirdametinib at twice a day and lifirafenib at once a day
Find a Location
Who is running the clinical trial?
BeiGeneLead Sponsor
175 Previous Clinical Trials
28,709 Total Patients Enrolled
SpringWorks Therapeutics, Inc.Industry Sponsor
12 Previous Clinical Trials
861 Total Patients Enrolled
Katie WoodStudy DirectorBeiGene
2 Previous Clinical Trials
228 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had severe bleeding in the last 28 days.My heart's pumping ability is below normal.My cancer has spread, cannot be surgically removed, and is getting worse.My cancer has spread to my brain.I haven't had major surgery or serious injuries in the last 4 weeks and don't expect to need major surgery during the study.I have an eye condition that could lead to central vision loss.I had to stop taking certain cancer drugs due to severe side effects.I have not received a live vaccine in the last 4 weeks, except for flu and COVID-19 shots.I haven't had serious heart problems in the last 6 months.I can carry out all my self-care but cannot do heavy physical work.My organs are working well and I haven't had a transfusion in the last 2 weeks.I have a severe illness that is not under control.I haven't taken systemic steroids in the last 2 weeks.My tumor is NRAS mutated, confirmed by tests, and is advanced or not responding to treatment.I do not have an active or known history of significant liver disease.I am a male who is either vasectomized or agrees to use contraception.I can provide previous tumor samples or agree to a new biopsy.I cannot become pregnant or agree to use birth control.I have a history of bleeding disorders, including Von Willebrand disease.I cannot swallow pills.I have a parathyroid disorder or had cancer-related high calcium levels.I have a history of glaucoma.I am at least 18 years old or of legal age in my area to consent.I am not taking any strong medications that affect liver enzymes.I have one of the specified types of cancer.I haven't had radiation or certain cancer treatments in the last 4 weeks.I am HIV positive.
Research Study Groups:
This trial has the following groups:- Group 1: Part A: Dose Escalation/Dose finding Dose Level Cohorts ranging in dose levels and dose regimens.
- Group 2: Part B: Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current count of participants in this research?
"Affirmative. The information available on clinicaltrials.gov declares that this medical experiment commenced recruiting participants on May 1st of 2019 and was most recently updated in February 22nd 2022; with the goal to include 105 people from two centres."
Answered by AI
Has the efficacy of mirdametinib been studied in any other clinical studies?
"Investigated first at the Dana Farber Cancer Institute in 2014, mirdametinib has so far been trialled 4 times with successful completion. Additionally, 4 more trials are underway - many of them based out of Houston, Texas."
Answered by AI
Is this experiment still seeking participants?
"Clinicaltrials.gov reflects that this clinical trial is still in the process of recruiting patients, with the initial posting on May 1st 2019 and a recent edit occurring February 22nd 2022."
Answered by AI
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