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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: Completed Phase 1 study, sponsored by Gilead Sciences.
NCT01631552 is a Phase 1 study that has completed, run by Gilead Sciences. The registered enrollment target is 515 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (758% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.03. An AE that met one or more of the following outcomes was classified as serious: * Fatal * Life-threatening * Disabling/incapacitating * Results in hospitalization or prolongs a hospi
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 |
What the finished NCT01631552 record still lists
NCT01631552 is an interventional study that assigns participants to a tested intervention. The registered 515 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (758% higher).
The record links to 0 conditions, and to 1 intervention - of which Sacituzumab Govitecan-hziy (SG) is the first listed.
NCT01631552 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01631552's enrollment target sits among peer trials
515 41st of 2000 higher than 1,960 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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