Study on BMX-001 and Paclitaxel for Adults with Advanced Ovarian or Endometrial Cancer

Sponsor: BioMimetix JV, LLC

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06620029

Provider View

This clinical trial is exploring a new treatment combination using BMX-001 and paclitaxel to help patients with advanced ovarian or endometrial cancer that has returned or spread. The study aims to find out if this combination can improve treatment outcomes and reduce side effects like nerve damage caused by chemotherapy.

Patient Parameters

Program Overview

This study is testing a new treatment approach for patients with advanced ovarian or endometrial cancer that has come back or spread. The treatment combines BMX-001, a drug that may protect healthy cells and boost the effects of chemotherapy, with paclitaxel, a common chemotherapy drug. The goal is to see if this combination can help control the cancer better and reduce side effects like nerve damage, which can affect quality of life. The trial will be conducted at the Duke Cancer Institute and will determine the best dose of BMX-001 to use with paclitaxel. Researchers will also look at how well the treatment works and how it affects patients' quality of life.

Description

This clinical trial is designed to find the best dose of BMX-001 when used with paclitaxel in patients with advanced ovarian or endometrial cancer. The study is in two phases: Phase 1 will test different doses to find the safest and most effective one, while Phase 2 will look at how well the treatment works. Patients will receive weekly doses of paclitaxel and BMX-001, starting with a low dose of BMX-001 and increasing if it is well-tolerated. The study will also measure how the treatment affects cancer growth and patients' quality of life. Up to 27 patients will participate, and the trial will use blood tests and other assessments to track the treatment's effects. The study aims to improve treatment options for patients with these types of cancer by finding a combination that enhances tumor control and reduces side effects.

Eligibility Criteria

Inclusion Criteria

  • Have advanced ovarian or endometrial cancer that has returned or spread after previous treatment.
  • Be 18 years or older.
  • Be in good overall health, able to carry out daily activities with minimal restrictions.
  • Understand and agree to participate in the study by signing a consent form.
  • Have cancer that can be measured or assessed through scans or other tests.
  • Have a negative pregnancy test if applicable.
  • Have good bone marrow, liver, and kidney function based on specific medical tests.
  • Have recovered from any recent surgeries before starting treatment.
  • Have not received any cancer treatments for at least 28 days before starting the study.

Exclusion Criteria

  • Have ongoing nerve damage from previous treatments.
  • Have untreated cancer that has spread to the brain or spinal cord.
  • Be receiving other cancer treatments at the same time.
  • Have previously received weekly paclitaxel for recurrent cancer.
  • Have significant heart disease or other serious health conditions.
  • Have active infections requiring hospital treatment.
  • Have severe allergies to study drugs or their ingredients.
  • Require regular blood transfusions or growth factor support.
  • Be pregnant or breastfeeding, or unwilling to use effective birth control during the study.
  • Have participated in previous studies with BMX-001.
  • Have conditions that increase the risk of heart rhythm problems.
  • Have other severe health issues that could interfere with the study.

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