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
| Parameter | Options |
|---|
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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| OU Health Stephenson Cancer | 73104 | Oklahoma City | Oklahoma |
| Swedish Center for Research and Innovation | 98122 | Seattle | Washington |
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