What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, such as aprinocarsen, olaparib, bevacizumab, and pazopanib, have various side effects. Aprinocarsen, when used alone, showed no significant clinical activity and its side effects were not detailed. Olaparib, a PARP inhibitor, commonly causes anemia, nausea, anorexia, and fatigue. Bevacizumab, an anti-angiogenic agent, can lead to hypertension, proteinuria, and increased risk of bleeding and gastrointestinal perforations. Pazopanib, another anti-angiogenic agent, is associated with hypertension, diarrhea, and hepatotoxicity. Chemotherapy agents like paclitaxel and topotecan, often used in combination with these targeted therapies, can cause myelosuppression, neuropathy, and alopecia.

What prior FDA approvals exist?

Several FDA-approved drugs for the treatment of advanced ovarian cancer include bevacizumab, a monoclonal antibody targeting VEGF, which has shown efficacy in improving progression-free survival. PARP inhibitors like olaparib, niraparib, and rucaparib are also approved for maintenance therapy in patients with recurrent, platinum-sensitive ovarian cancer. These agents are particularly relevant as they are used in advanced stages and after other treatments have failed, similar to the context in which AMXI-5001 is being studied.

What other types of research exist?

Promising novel alternatives to AMXI-5001 for ovarian cancer patients include: 1) Olaparib, a PARP inhibitor, which has shown effectiveness in various ovarian cancer settings, particularly for patients with BRCA mutations. 2) Niraparib, another PARP inhibitor, which has demonstrated efficacy in combination with immunotherapies like nivolumab or ipilimumab. 3) Bevacizumab, an anti-VEGF monoclonal antibody, which has been used in maintenance therapy and shows potential based on molecular subtypes. These therapies have been evaluated in recent clinical trials and may offer effective treatment options in 2024.

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AMXI-5001 for Advanced Cancers

Phase 1 & 2

Recruiting

Research Sponsored by AtlasMedx, Incorporated

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Co-operative Oncology Group (ECOG) PS 0-1

Has evaluable or measurable tumor(s) in dose escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.

Must not have

Any clinically significant disease or condition affecting a major organ system

Significant cardiovascular disease or electrocardiogram (ECG) abnormalities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, AMXI-5001, for adults with advanced cancers who haven't been helped by other treatments. The drug is taken by mouth and works by stopping cancer cells from repairing and growing. The study aims to find the best dose and see how safe and effective the drug is.

Who is the study for?

This trial is for adults with advanced cancers like ovarian, prostate, pancreatic, or breast cancer that have worsened despite standard treatments. Participants must be over 18 and have a performance status indicating they can care for themselves (ECOG PS 0-1). They should not be on current cancer treatment and must not take certain drugs affecting liver enzymes.

What is being tested?

AMXI-5001 is being tested in two phases: Phase I to find the right dose and Phase II to assess its safety and effectiveness. Patients with advanced malignancies who haven't responded well to other therapies are given escalating doses of AMXI-5001 until an optimal dose is found.

What are the potential side effects?

While specific side effects of AMXI-5001 aren't listed here, common ones from similar trials may include nausea, fatigue, allergic reactions, blood count changes leading to increased infection risk or bleeding tendencies, liver function abnormalities, and potential heart issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer can be measured or evaluated using scans or tests.

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My cancer has worsened despite treatment.

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I am 18 years old or older.

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My cancer is advanced or has spread to other parts of my body.

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My cancer has not responded to any treatment known to work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any major organ system diseases.

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I do not have serious heart disease or abnormal heart tests.

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I am currently undergoing cancer treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 24 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

Characterize safety profile of AMXI-5001

Determine the Maximum Tolerated Dose (MTD)

Determine the Recommended Phase 2 Dose (RP2D) for AMXI-5001 as monotherapy

Secondary study objectives

Determine change in anti-tumor activity following administration of AMXI-5001

Measure concentration of AMXI-5001 in plasma samples

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: AMXI-5001 TreatmentExperimental Treatment2 Interventions

Single Arm Study, all participants will receive AMXI-5001.

0 / 9Eligibility criteria met

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

Common treatments for ovarian cancer include chemotherapy, targeted therapy, and investigational agents like AMXI-5001. Chemotherapy drugs, such as carboplatin and paclitaxel, work by damaging the DNA of cancer cells, preventing them from dividing and growing. Targeted therapies, like bevacizumab, inhibit angiogenesis, the process by which tumors develop new blood vessels, thereby starving the tumor of nutrients. PARP inhibitors, another targeted therapy, block the enzyme poly(ADP-ribose) polymerase, which helps repair DNA damage in cancer cells, leading to cell death. Investigational agents like AMXI-5001 are being studied for their potential to treat advanced malignancies by targeting specific pathways involved in cancer cell survival and proliferation. Understanding these mechanisms is crucial for ovarian cancer patients as it helps in selecting the most effective treatment strategy based on the tumor's characteristics and the patient's overall health.

Potential targets for ovarian clear cell carcinoma: a review of updates and future perspectives.