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Monoclonal Antibody
ME-344 + Bevacizumab for Colorectal Cancer
Phase 1
Waitlist Available
Research Sponsored by MEI Pharma, Inc.
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 1 year
Awards & highlights
Study Summary
This trial will study a new drug combo to see if it's safe & effective for people with recurrent colon cancer.
Who is the study for?
This trial is for adults over 18 with metastatic colorectal cancer that has returned after treatment. They must have tried standard therapies including certain chemotherapies and possibly other drugs depending on their tumor type. Participants need good bone marrow, liver, and kidney function and can't join if they've had recent bevacizumab therapy or suffer from conditions like severe neuropathy, active hepatitis B or C, brain tumors, uncontrolled heart disease, high blood pressure or diabetes.Check my eligibility
What is being tested?
The study tests the combination of ME-344, a drug that targets cancer cell energy production, with bevacizumab in patients whose metastatic colorectal cancer has come back. It's an early-phase trial to check how safe this combo is and how well it works at different doses/schedules.See study design
What are the potential side effects?
Potential side effects may include those commonly associated with chemotherapy such as fatigue, nausea, increased risk of infection due to low blood counts; plus specific risks related to bevacizumab like bleeding problems or hypertension. The new drug ME-344 might also have unique side effects which are being studied.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS) rate at 16 weeks
Secondary outcome measures
Overall Response Rate (ORR)
Safety and tolerability of ME-344 administered in combination with bevacizumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: ME-344 and BevacizumabExperimental Treatment2 Interventions
ME-344 (IV) Cohort 1: Days 1, 8, and 15 of each 28-day cycle. Cohort 2: Days 1 and 15 of each 28-day cycle.
Bevacizumab (IV) Cohorts 1 and 2: Days 1 and 15 of each 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
ME-344
2016
Completed Early Phase 1
~40
Find a Location
Who is running the clinical trial?
MEI Pharma, Inc.Lead Sponsor
13 Previous Clinical Trials
838 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is a type of colon or rectum cancer that has spread.It's been over a month since my last cancer treatment or trial drug.My bone marrow, liver, and kidneys are functioning well.I have had a disease affecting my brain or spinal cord.I have symptoms from brain metastases, spinal issues, or a brain tumor.I do not have serious heart problems or recent heart attacks.I have moderate to severe numbness, tingling, or pain in my hands or feet.I do not have uncontrolled high blood pressure, diabetes, active stomach ulcers, unhealed wounds, or serious infections.I am 18 years old or older.I have a stable blood clot condition and have been on a blood thinner for at least 2 weeks.I haven't had Bevacizumab or Aflibercept in the last 3 weeks.I have an active infection with the human T-cell leukemia virus.I have brain metastases or a primary brain tumor that hasn't been treated.My cancer did not respond or I couldn't tolerate previous treatments including specific chemotherapies and targeted therapies.
Research Study Groups:
This trial has the following groups:- Group 1: ME-344 and Bevacizumab
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.
To what extent is ME-344 and Bevacizumab a viable option for patient safety?
"ME-344 and Bevacizumab have not yet been extensively studied, so their safety is estimated to be a 1 on our scale of 1 to 3. This being said, Phase I trials offer limited data in regards to efficacy and security."
Answered by AI
Are any positions still available for participation in this investigation?
"Affirmative. Clinicaltrials.gov confirms that this clinical trial, which was initially advertised on May 8th 2023, is actively selecting participants for the study. Forty patients will be recruited from 2 distinct medical facilities."
Answered by AI
What is the current enrolment size for this medical experiment?
"Affirmative. Visiting clinicaltrials.gov will show that the medical study, which was published on May 8th 2023, is actively searching for participants. 40 patients need to be recruiter from 2 different treatment centres."
Answered by AI
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