Open-label Rollover Study to Assess Long-Term Safety in Subjects with Metastatic Cancers that are Benefiting from Continuation of Therapy with Sacituzumab Govitecan.
- Conditions
- Metastatic Solid TumorsMedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-004868-22-BE
- Lead Sponsor
- Gilead Sciences Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
1. Female or male subjects, = 18 years of age, able to understand and give written informed
consent;
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method