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Rollover Study in Subjects With Metastatic Solid Tumors Benefiting From Therapy With Sacituzumab Govitecan

2020-03-27 03:25:30 | BioPortfolio

Summary

Rollover study designed to evaluate long-term safety in subjects with metastatic solid tumors that are benefiting from continued treatment with sacituzumab govitecan.

Patients currently receiving, clinically benefiting from, and tolerating sacituzumab govitecan in an Immunomedics-sponsored parent study planned for closure will be considered for enrollment.

Description

This is an open-label, longitudinal cohort, rollover study. Eligible participants will receive sacituzumab govitecan therapy at the dose they were receiving in the parent study. No participant will receive more than 10 mg/kg dose of sacituzumab govitecan. Treatment with sacituzumab govitecan will be uninterrupted as eligible participants rollover/transition from the parent study to the rollover study. Participants may continue to receive sacituzumab govitecan until they experience toxicity, disease progression, loss of clinical benefit, lost to follow-up, or upon participant withdrawal of consent or Sponsor termination of the study.

Study Design

Conditions

Solid Tumor

Intervention

Sacituzumab Govitecan

Status

Not yet recruiting

Source

Immunomedics, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-03-27T03:25:30-0400

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Medical and Biotech [MESH] Definitions

A transplantable, poorly differentiated malignant tumor which appeared originally as a spontaneous breast carcinoma in a mouse. It grows in both solid and ascitic forms.

A malignant cystic or semisolid tumor most often occurring in the ovary. Rarely, one is solid. This tumor may develop from a mucinous cystadenoma, or it may be malignant at the onset. The cysts are lined with tall columnar epithelial cells; in others, the epithelium consists of many layers of cells that have lost normal structure entirely. In the more undifferentiated tumors, one may see sheets and nests of tumor cells that have very little resemblance to the parent structure. (Hughes, Obstetric-Gynecologic Terminology, 1972, p184)

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