Trials / Completed
CompletedNCT01631552
Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer
A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancer
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 515 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
The outcome measures are planned to be assessed up to the data cutoff date. Following the data cutoff date, the participants will either stay on the study and will be followed for safety data collection or rolled into another Gilead-sponsored study. Therefore, only safety data will be collected after the data cutoff date.
Conditions
- Gastric Adenocarcinoma
- Esophageal Cancer
- Hepatocellular Carcinoma
- Non-small Cell Lung Cancer
- Small Cell Lung Cancer
- Ovarian Epithelial Cancer
- Carcinoma Breast Stage IV
- Hormone-refractory Prostate Cancer
- Head and Neck Cancers- Squamous Cell
- Renal Cell Cancer
- Urinary Bladder Neoplasms
- Cervical Cancer
- Endometrial Cancer
- Glioblastoma Multiforme
- Triple Negative Breast Cancer
- Pancreatic Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sacituzumab Govitecan-hziy (SG) | Administered via intravenous (IV) infusion |
Timeline
- Start date
- 2012-12-17
- Primary completion
- 2019-03-01
- Completion
- 2020-08-13
- First posted
- 2012-06-29
- Last updated
- 2021-08-12
- Results posted
- 2021-04-06
Locations
12 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01631552. Inclusion in this directory is not an endorsement.