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Redox-active manganese metalloporphyrin compound

BMX-001 + Paclitaxel for Ovarian Cancer

Phase 1 & 2

Waitlist Available

Led By Angeles Secord

Research Sponsored by BioMimetix JV, LLC

Eligibility Criteria Checklist

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

Must have

At least 28 days between termination of prior anticancer or hormonal therapy and first administration of BMX-001

Aged 18 years or older

Must not have

Serious active infection requiring IV antibiotics and/or hospitalization within 7 days of enrollment

Residual Grade 2 peripheral neuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new drug called BMX-001 in combination with standard chemotherapy (paclitaxel) to see if it can improve treatment outcomes for patients with ovarian and endomet

Who is the study for?

This trial is for adults with advanced, recurrent, metastatic ovarian or endometrial cancer who have faced issues with chemotherapy resistance and nerve damage from previous treatments. Specific eligibility criteria are not provided but typically include factors like health status and prior treatment history.

What is being tested?

The study tests BMX-001 in combination with the chemotherapy drug Paclitaxel (Taxol). It aims to find a safe dosage that enhances tumor control while reducing side effects, especially nerve damage caused by Taxol. The trial will also monitor how well tumors respond to this treatment combo.

What are the potential side effects?

While specific side effects are not listed, typical ones associated with Paclitaxel include nerve damage, fatigue, hair loss, nausea. BMX-001 aims to reduce these side effects while enhancing anti-tumor efficacy.

Eligibility Criteria

Inclusion Criteria

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

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It has been at least 28 days since my last cancer or hormonal treatment.

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I am 18 years old or older.

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I can perform all my usual activities without assistance.

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My cancer can be measured by scans or has signs like fluid buildup.

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My kidney function is within the required range.

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My ovarian or endometrial cancer has returned and worsened after standard treatment.

Exclusion Criteria

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

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I have not had a serious infection requiring IV antibiotics or hospital stay in the last week.

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I have moderate numbness or pain in my hands or feet.

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I have a serious heart condition.

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I have previously been treated with or participated in a study involving BMX-001.

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I have a wound, ulcer, or bone fracture that hasn’t healed.

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I have previously received weekly PTX for cancer recurrence.

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I am currently receiving treatment for my cancer.

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I am allergic to specific drugs or ingredients used in the study.

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I need regular blood or platelet transfusions, or injections to boost my white blood cells.

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I am not pregnant, breastfeeding, and agree to use contraception or practice abstinence.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

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

Primary study objectives

To determine the Recommended Phase 2 Dose of BMX-001 in combination with paclitaxel in a safety cohort of patients. This would be carried forward as the dose to be used in the expanded cohort portion of the trial.

Secondary study objectives

To describe patient-reported outcomes of health related quality of life (HRQoL) using Functional Assessment of Cancer Therapy/Gynecologic Oncology - Neurotoxicity (FACT/GOG-NTX) Questionnaire and monofilament testing

To evaluate preliminary efficacy based on objective response rate (ORR) using RECIST v 1.1 per investigator assessment on all evaluable subjects enrolled

To evaluate preliminary efficacy based on progression free survival (PFS) using RECIST v 1.1 per investigator assessment on all evaluable subjects enrolled

Other study objectives

To assess correlations between B cell lymphoma/ leukemia 2 (BCL2), Nrf2, TNF- # and NFkB RNA and protein expression and activation, ctDNA, and clinical endpoints (response and progressionfree survival) in all evaluable subjects enrolled

To characterize the Cmax of BMX-001 when delivered in combination with PTX in recurrent ovarian or endometrial cancer in all evaluable subjects enrolled.

To characterize the Tmax and half life of BMX-001 when delivered in combination with PTX in recurrent ovarian or endometrial cancer in all evaluable subjects enrolled.

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