Study on PLX038 for Treating Metastatic Platinum-resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05465941

Provider View

This clinical trial is testing a new drug, PLX038, to see if it can shrink tumors in patients with ovarian, primary peritoneal, and fallopian tube cancers that have spread and are resistant to platinum-based treatments.

Patient Parameters

Program Overview

This phase II study is exploring whether the drug PLX038 can help reduce tumors in patients with ovarian, primary peritoneal, and fallopian tube cancers that have spread to other parts of the body and are resistant to platinum-based chemotherapy. PLX038 works by blocking certain enzymes that cancer cells need to grow.

Description

The main goal of this study is to find out how well PLX038 can shrink tumors in patients with metastatic platinum-resistant high-grade serous ovarian cancer. Researchers will also look at how long patients live without the cancer getting worse and their overall survival. They will assess how well patients tolerate PLX038 and study how the drug affects certain DNA structures in cancer cells.

Patients will receive PLX038 through an IV once every 21 days, as long as the cancer does not progress or cause unacceptable side effects. During the study, patients will have CT scans, biopsies, and provide blood and stool samples. After finishing the treatment, patients will have follow-up visits for up to five years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of high-grade serous ovarian cancer, including ovarian, fallopian tube, or primary peritoneal cancer.
  • Cancer must have returned and become resistant to platinum-based treatments after initially responding.
  • No more than one previous treatment for platinum-resistant cancer.
  • Must have measurable cancer according to specific criteria.
  • Cancer must be suitable for two biopsies.
  • Expected to live at least 12 more weeks.
  • Must be in good overall health with a performance status of 0, 1, or 2.
  • Must have adequate blood counts and organ function based on specific tests.
  • Must not be pregnant and agree to use contraception if of childbearing potential.
  • Must be willing to provide blood and tissue samples for research.
  • Must agree to return for follow-up visits.

Exclusion Criteria

  • Pregnant or nursing individuals, or those not willing to use contraception.
  • Have a type of cancer other than high-grade serous carcinoma.
  • Have had chemotherapy, immunotherapy, or radiotherapy within the last 4 weeks.
  • Have had another cancer within the last 2 years, with some exceptions.
  • Have uncontrolled health issues like recent heart attack or severe heart problems.
  • Have a history of significant heart disease or treatment with heart-damaging drugs.
  • Have HIV, unless on effective treatment with undetectable viral load.
  • Have hepatitis, unless under control or cured.
  • Have a history of serious gastrointestinal issues.
  • Have other severe health conditions that could interfere with the study.
  • Require blood thinners that affect clotting tests, with some exceptions.
  • Have untreated or active brain disease, unless stable after treatment.
  • Have genetic conditions affecting drug metabolism.
  • Need treatment with certain drugs during the study.

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