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NCT01631552 · ClinicalTrials.gov registry record · Phase 1
Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer
A Phase 1 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 515
- Enrollment target
NCT01631552 is a Phase 1 study that has completed, run by Gilead Sciences. The registered enrollment target is 515 participants.
The verdict
NCT01631552, a Phase 1 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 515 participants
- Enrollment target
Study Summary
The primary objective in Phase I is to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent administered in 21-day treatment cycles in previously treated participants with advanced epithelial cancer. In Phase II, the primary objective is to evaluate the safety and efficacy of sacituzumab govitecan-hziy administered in 21-day treatment cycles at a dose selected in Phase I. Tumor types in the study will include: cervical, colorectal, endometrial, ovarian, esophageal, gastric adenocarcinoma, glioblastoma multiforme, head and neck cancers- squamous cell, hepatocellular, prostate, non-small-cell lung cancer, pancreatic, renal cell, small-cell lung cancer, non-triple negative breast cancer (non-TNBC), triple-negative breast cancer (TNBC) and metastatic urothelial cancer (mUC).
Interventions
- DRUG Sacituzumab Govitecan-hziy (SG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 515 participants |
| Start Date | 2012-12-17 |
| Est. Completion | 2020-08-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01631552
The ClinicalTrials.gov registry entry for NCT01631552 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 515 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sacituzumab Govitecan-hziy (SG) is the first listed.
NCT01631552 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01631552 about?
NCT01631552 is a clinical study titled "Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer". The primary objective in Phase I is to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent administered in 21-day treatment cycles in previously treated participants with advanced epithelial cancer. In Phase II, the primary objective is to evaluate the safety an...
What is the current status of trial NCT01631552?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 515 participants. The study started on 2012-12-17. Estimated completion is 2020-08-13.
What interventions are being tested in trial NCT01631552?
The interventions under investigation include: Sacituzumab Govitecan-hziy (SG) (DRUG).
Who is sponsoring clinical trial NCT01631552?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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