Study on the Effects of 2X-121 for Treating Recurrent, Advanced Ovarian Cancer

Sponsor: Allarity Therapeutics

Sponsor score: 0

ClinicalTrials ID:NCT03878849

This clinical trial is testing different doses of a new drug, 2X-121, to find the best dose for treating advanced ovarian cancer that has returned and is resistant to platinum-based chemotherapy.

Patient Parameters

Program Overview

The aim of this study is to determine the best dose of the drug 2X-121 for patients with advanced ovarian cancer that has come back and does not respond to platinum-based chemotherapy. The study will compare two different dosing schedules to see which is more effective and safer for patients.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced ovarian, fallopian tube, or primary peritoneal cancer with specific types of cell characteristics.
  • Cancer must have returned within 6 months after the last platinum-based chemotherapy or be ineligible for such treatment.
  • Have received no more than one previous treatment for platinum-resistant cancer.
  • Have measurable cancer that can be seen on a CT scan or MRI.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of more than 16 weeks.
  • Have recovered from any previous treatments or surgeries.
  • Meet specific blood and organ function criteria based on lab tests.
  • Provide a tumor sample from the current relapse if possible.
  • Women of childbearing potential must have a negative pregnancy test and use effective contraception during and for six months after the study.

Exclusion Criteria

  • Cancer that progressed during the last platinum-based chemotherapy.
  • Currently receiving other cancer treatments or investigational drugs.
  • Have another type of cancer, except for certain early-stage cancers that are considered cured.
  • Have an active infection requiring antibiotics.
  • Have known HIV or active hepatitis B or C.
  • Have significant heart disease or recent heart events.
  • Have conditions or take medications that could interfere with the study.
  • Have difficulty taking oral medication or have digestive issues that affect drug absorption.
  • Require immediate treatment for symptoms or complications of cancer.
  • Cannot be regularly followed up due to personal circumstances.
  • Are closely related to or dependent on the study sponsor or investigator.
  • Have fluid buildup in the abdomen requiring drainage within two weeks before joining the study.

Locations

FACILITYZIPCITYSTATE
OU Health Stephenson Cancer73104Oklahoma CityOklahoma
Swedish Center for Research and Innovation98122SeattleWashington

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