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NCT06040970 · ClinicalTrials.gov registry record · Phase 1
Sacituzumab Govitecan in Combination With Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer
A Phase 1 study of Ovarian Cancer and Malignant Neoplasm of Uterus, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT06040970: Recruiting Phase 1 study of Ovarian Cancer and Malignant Neoplasm of Uterus, sponsored by Icahn School of Medicine at Mount Sinai.
NCT06040970 is a Phase 1 study of Ovarian Cancer and Malignant Neoplasm of Uterus that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 54 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06040970, a Phase 1 study of Ovarian Cancer and Malignant Neoplasm of Uterus, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label, Phase 1 study with a dose expansion cohort of Sacituzumab Govitecan in Combination with Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer. The goal of the study is to determine the optimal dose of sacituzumab govitecan for use in combination with cisplatin for treatment of epithelial ovarian and endometrial cancers.
Primary Outcome
Safety Run-In Phase: The primary endpoint of the safety run-in phase is to determine DLT and the recommended DEC dose of sacituzumab govitecan in combination with a fixed schedule of cisplatin in patients with ovarian and endometrial cancers. DLT is defined as any therapy-attributable adverse event (AE) requiring discontinuation of therapy within one cycle of combined therapy; specifically grade 3 or 4 non-hematologic toxicity and grade 4 hematologic toxicity events. These will be assessed via N
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Sacituzumab
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai Division of Hematology and Medical Oncology - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2024-10-23 |
| Est. Completion | 2027-07-01 |
| Phase | Phase 1 |
What NCT06040970 shows while recruiting
NCT06040970 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 2 interventions - of which Cisplatin is the first listed.
NCT06040970 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06040970 about?
NCT06040970 is a clinical study titled "Sacituzumab Govitecan in Combination With Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer". This is an open-label, Phase 1 study with a dose expansion cohort of Sacituzumab Govitecan in Combination with Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer. The goal of the study is to determine the optimal dose of sacituzumab govitecan for use in combination with cisplat...
What is the current status of trial NCT06040970?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2024-10-23. Estimated completion is 2027-07-01.
What conditions does trial NCT06040970 study?
This clinical trial studies the following conditions: Ovarian Cancer, Malignant Neoplasm of Uterus.
What interventions are being tested in trial NCT06040970?
The interventions under investigation include: Cisplatin (DRUG), Sacituzumab (DRUG).
Who is sponsoring clinical trial NCT06040970?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06040970 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06040970's enrollment target sits among peer trials
54 204th of 322 higher than 118 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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