Open-label Rollover Study to Evaluate Long-Term Safety in Subjects with Metastatic Solid Tumors that are Benefiting from Continuation of Therapy with Sacituzumab Govitecan.

Immunomedics, Inc.0 个研究点目标入组 200 人开始时间: 2020年6月9日最近更新: 2021年4月5日

适应症

试验速览

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•1. Female or male subjects, = 18 years of age, able to understand and give written informed
•2. Receiving ongoing treatment with sacituzumab govitecan in an Immunomedics sponsored
•study that is closing;
•3. Continuing to receive clinical benefit from sacituzumab govitecan therapy;
•4. Female subjects of childbearing potential must be willing to use 2 methods of birth control or to be surgically sterile or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for >2 years;
•5. Male subjects must agree to use an adequate method of contraception starting with the
•first dose of the study drug through 3 months after the last dose of the study drug.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•1. Women who are pregnant or lactating;
•2. Initiated therapy with another cancer therapeutic agent (investigational or standard of
•care) since receiving the last dose of the study drug on the Immunomedics-sponsored
•parent study in which they participated;
•3. Experienced a toxicity from sacituzumab govitecan that resulted in permanent
•discontinuation of therapy;
•4. Have an active serious infection requiring antibiotics (Contact medical monitor for
•clarification);
•5. Have other concurrent medical or psychiatric conditions that, in the Investigator's
•opinion, may be likely to confound study interpretation or prevent completion of study
•procedures and follow-up examinations.

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