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Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas

Plain-language guide to NCT06865677: phase 2 interventional trial of Octreotide, endometriosis, 2 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06865677
Phase
phase 2
Status
terminated early
Start
2025-06-09
Completion (planned or actual)
2025-07-01
Participants
2 (actual)
Design
na, open label (everyone knows who gets what), treatment
Conditions studied
Recurrent Platinum Resistant Epithelial Ovarian Carcinoma; Recurrent Epithelial Endometrial Carcinoma; Recurrent Epithelial Cervical Carcinoma
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 2 trial tested Octreotide for endometriosis.

It had 1 arm (groups): Arm 1 -Treatment with Sacituzumab Govitecan (SG) (experimental).

Treatment with Sacituzumab Govitecan (SG).

The registry classes the interventions as diagnostic test, drug and procedure.

More on the Plan

Background: * Human trophoblast cell-surface marker (TROP2) is a surface glycoprotein originally identified in human placental tissue and highly expressed in gynecologic malignancies.

Objective: -To determine the objective response rate (ORR) of sacituzumab govitecan (SG) in participants with recurrent gynecological malignancies, calculated for each individual tumor histology by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Pre-treatment biopsies and serial blood samples will be collected for the correlative studies. * Treatment will be given for a maximum of 5 years or until disease progression or unacceptable toxicities. * Up to 66 evaluable participants will be enrolled.

Who Took Part

2 actual participants took part.

It was open to women only aged from 18 years up to 120 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Participants without known BRCA mutation and platinum-resistant tumors must have had prior bevacizumab or not eligible for bevacizumab-based therapy (i.e., history of proteinuria). Participants must have histologically or cytologically confirmed recurrent epithelial (i.e., endometrioid or serous) endometrial carcinoma that is refractory to standard treatment. Participants must have histologically or cytologically confirmed recurrent epithelial cervical (i.e. squamous or adeno) carcinoma that is refractory to standard treatment. Participants must have received prior bevacizumab-based therapy or not eligible for bevacizumab-based therapy (i.e., history of proteinuria). Participants must have received at least two systemic therapies including at least one platinum-based therapy regimen.

The full record lists 31 inclusion and 17 exclusion criteria; among the exclusions: participants who are receiving any other investigational agents; participants with any other concomitant invasive malignancies; prior treatment with trophoblast cell-surface marker (trop2)-targeting antibody drug conjugates (adc). participants with prior use of other adcs are eligible.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Octreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2025-06-09 with completion listed for 2025-07-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Overall Response Rate (Partial Response or Complete Response) of Sacituzumab Govitecan in Participants With Recurrent Gynecological Malignancies, Calculated for Each Individual Tumor Histology by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (time frame: Up to 22 days).

It also tracked 4 secondary outcomes, for example Median Duration of Response (DOR) of Sacituzumab Govitecan (SG), Overall Survival of Participants Receiving Sacituzumab Govitecan (SG), Progression Free Survival (PFS) of Participants Receiving Sacituzumab Govitecan (SG) and Adverse Events (AE) Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, by Type and Grade of Toxicity.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Octreotide in 2 people with endometriosis.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Octreotide compound page, Endometriosis research.

Our Notes on the Compound

Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.