Study on Sacituzumab Govitecan for Patients with Platinum-resistant Ovarian Cancer
Sponsor: Yale University
ClinicalTrials ID:NCT06028932
This clinical trial is testing a new drug, sacituzumab govitecan, for patients with ovarian, fallopian tube, or primary peritoneal cancer that has not responded to platinum-based treatments. The study aims to see if this drug can help control the cancer.
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Program Overview
This study is exploring the effectiveness of sacituzumab govitecan in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back or persisted despite treatment with platinum-based chemotherapy. The trial is open-label, meaning both the researchers and participants know what treatment is being given.
Description
This clinical trial is designed to evaluate how well sacituzumab govitecan works in patients with ovarian, fallopian tube, or primary peritoneal cancer that has returned or continued to grow after treatment with platinum-based chemotherapy. The study is open-label, which means that both the doctors and the patients know what treatment is being administered. Participants will receive sacituzumab govitecan to see if it can help control their cancer. The study will monitor the drug's effects on the cancer and any side effects experienced by the participants.
Eligibility Criteria
Inclusion Criteria
- Have ovarian, fallopian tube, or primary peritoneal cancer that has returned or persisted after platinum-based treatment.
- Have a tumor that can be measured by scans or physical exams.
- Have a sample of the tumor available for testing.
- Be in good overall health with adequate blood cell counts and organ function.
- Be at least 18 years old.
- Have an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have recovered from any previous treatments or surgeries.
- Have received no more than two prior chemotherapy treatments for recurrent cancer.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
- Be at least two weeks past any previous treatments or high-dose steroids.
- Have signed an informed consent form agreeing to participate in the study.
Exclusion Criteria
- Women who are pregnant or breastfeeding.
- Have allergies to the study drug or its components.
- Require ongoing treatment with certain medications that interfere with the study drug.
- Have other medical or psychiatric conditions that could interfere with the study.
- Have had another invasive cancer within the last five years, except for certain skin or cervical cancers.
- Have significant heart disease or uncontrolled high blood pressure.
- Have severe lung disease or other serious medical conditions.
- Have active brain cancer or untreated brain metastases.
- Have uncontrolled seizures or active neurological disease.
- Have active infections like HIV, hepatitis B, or hepatitis C.
- Have a bleeding disorder or a history of significant bleeding.
- Have a large tumor mass over 7 cm, unless approved by the study investigator.
- Have severe digestive issues like nausea, vomiting, or intestinal blockage.
- Have had severe reactions to similar drugs in the past.
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