What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, particularly those involving Bevacizumab, can lead to several side effects. Bevacizumab is associated with hypertension, gastrointestinal perforations, fistulas, thromboembolic events, and proteinuria. Chemotherapeutic regimens like FOLFOX and FOLFIRI, which are often used in combination with Bevacizumab, can cause neutropenia, diarrhea, mucositis, neuropathy, and fatigue. The combination of these treatments may increase the risk and severity of these side effects.

What prior FDA approvals exist?

Bevacizumab, an anti-angiogenic agent, has been FDA-approved for the treatment of metastatic colorectal cancer in combination with chemotherapy regimens such as FOLFOX (folinic acid, fluorouracil, and oxaliplatin) and FOLFIRI (folinic acid, fluorouracil, and irinotecan). These combinations have shown improvements in progression-free survival and overall survival. While oxidative phosphorylation pathway inhibitors like ME-344 are still under investigation, they represent a novel approach that could potentially enhance the efficacy of existing treatments like bevacizumab.

What other types of research exist?

Promising alternatives to ME-344 in combination with Bevacizumab for colorectal cancer patients include: 1) Sequential administration of Panitumumab (an anti-EGFR monoclonal antibody) followed by Bevacizumab, which has shown significant tumor growth inhibition and reduced cell proliferation. 2) The combination of Temsirolimus (an mTOR inhibitor) with Bevacizumab, which has demonstrated a response rate of 25% in previously treated patients. 3) Investigational agents targeting the PI3K/PTEN/AKT/mTOR pathway, which are being evaluated for their potential in colorectal cancer treatment.

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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 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of ME-344 and bevacizumab in patients with metastatic colorectal cancer who haven't responded to standard treatments. ME-344 disrupts the energy production in cancer cells, and bevacizumab blocks the growth of blood vessels that tumors need.

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.

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.

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 ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS) Rate at 16 Weeks

Secondary study objectives

Overall Response Rate (ORR)

Treatment Emergent Adverse Events for ME-344 Administered in Combination With Bevacizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~5540

ME-344

2016

Completed Early Phase 1

~40

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The treatment of colorectal cancer often involves targeting specific pathways that cancer cells rely on for growth and survival. ME-344, an oxidative phosphorylation pathway inhibitor, disrupts the energy production in cancer cells, leading to cell death. Bevacizumab, an anti-angiogenic agent, inhibits vascular endothelial growth factor (VEGF), reducing the blood supply to tumors and thereby starving them of necessary nutrients and oxygen. Combining these treatments can be particularly effective for colorectal cancer patients as it simultaneously attacks the cancer cells' energy production and their ability to sustain growth through blood vessel formation.