Clinical Trial

Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas

Terminated Phase 2
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Why the trial stopped
This protocol was terminated prematurely because the prior principal investigator departed the Institute without treating any participants.
Summary
Background: Cancers of the female reproductive organs often come back after treatment. A drug called sacituzumab govitecan (SG) has been approved for use in other types of cancers. Researchers want to see if SG can also help people with ovarian, endometrial, or cervical cancers. Objective: To test SG in people with ovarian, endometrial, or cervical cancers. Eligibility: People aged 18 years and older with ovarian, endometrial, or cervical cancer. Their cancers must have returned after at least 2 rounds of standard treatments. Design: Participants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and a test of their heart function. They also will have biopsies to get new tissues samples taken from their tumors. SG is infused through a tube attached to a needle inserted into a vein in the arm. Treatment will be given in 21-day cycles. Participants will receive SG on days 1 and 8 of each cycle. Each infusion takes 1 to 3 hours. Participants may receive SG for up to 5 years. They can continue as long as the drug is helping them. Imaging scans and other tests will be repeated throughout the study period. Participants will have an end-of-treatment visit within 2 weeks and a safety visit about 30 days after they stop treatment. Physical exams, blood tests, and imaging scans may be repeated. Participants will then be contacted by phone every 6 months for up to 10 years after their first dose of SG. Sponsoring Institution: National Cancer Institute...
Protocol Amendment History 60 amendments
This ClinicalTrials.gov record has been amended 60 times since 2025-03-07; most recent amendment 2026-01-05.
Status change: Completed → Terminated 2026-01-05
Status change: Recruiting → Completed 2025-10-23
Status change: Suspended → Recruiting 2025-08-30
Status change: Recruiting → Suspended 2025-06-19
Status change: Not Yet Recruiting → Recruiting 2025-05-28
Trial Details
NCT Number NCT06865677
Lead Sponsor National Cancer Institute (NCI)
Conditions Recurrent Platinum Resistant Epithelial Ovarian Carcinoma, Recurrent Epithelial Endometrial Carcinoma, Recurrent Epithelial Cervical Carcinoma
Enrollment 2 participants
Start Date 2025-06-09
Primary Completion 2025-07-01 (estimated)
Study Completion 2025-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-21