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Sacituzumab Govitecan for Cervical Cancer
Study Summary
This trial studies an antibody drug to treat recurrent or persistent cervical cancer.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 529 Patients • NCT02574455Trial Design
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- I have not had an intestinal blockage in the last 6 months.I have been treated with topoisomerase I inhibitors before.I have HIV with a detectable viral load or take medication that affects SN-38 metabolism.I am 18 years old or older.I have had at most 2 chemotherapy treatments for my cervical cancer.I am not on any medication that is not allowed in the study.I haven't had any cancer except for skin cancer or cervical pre-cancer in the last 5 years.I have an uncontrolled seizure disorder or active neurological disease.I have a bleeding disorder or condition that causes excessive bleeding.I have moderate to severe loss of appetite, nausea, vomiting, or signs of a blocked intestine.I can provide a sample of my tumor for testing.My cancer has formed a large tumor or mass.I have had a severe allergic reaction or major side effects to irinotecan.I have had serious heart problems in the last 6 months.My cervical cancer has returned or persisted after at least one chemotherapy treatment.My surgery removed most or all of my tumor.It has been over 2 weeks since my last treatment or major surgery.I have recovered from major side effects of my last treatment.My cancer can be measured by tests or scans.I stopped taking high dose steroids more than 2 weeks ago.I had immunotherapy before but it's been 4 weeks since my last treatment.I have had severe lung problems like COPD in the last 6 months.My cancer has come back and can be measured.I have cancer that has spread to my brain or its coverings.My chemotherapy during initial radiation for cervical cancer doesn't count as a treatment for persistent or recurrent cancer.I am in good physical condition, have normal kidney, liver, and bone marrow function, and have signed a consent form.
- Group 1: Sacituzumab Govitecan
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What have been the results of safety assessments with Sacituzumab Govitecan?
"Since Sacituzumab Govitecan is in the Phase 2 trial stages, our team at Power has assessed its safety to be a score of 2. This indicates that while there are some preliminary safety data available, efficacy is yet to be confirmed with clinical trials."
Is enrollment still possible in this clinical study?
"Affirmative, the research posted to clinicaltrials.gov shows that this trial is presently seeking participants. The study was first advertised on May 25th 2023 and has since been updated with new information. This medical experiment necessitates 20 individuals from 1 location to participate in the study's proceedings."
What is the upper limit of participants in this medical research project?
"Affirmative, according to clinicaltrials.gov this research endeavour is currently seeking volunteers. The trial was initially posted on May 25th 2023 and its latest update occurred on the same day. This study desires a total of 20 participants at 1 medical site."
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