Trials / Completed
CompletedNCT03087591
APN401 in Treating Patients With Recurrent or Metastatic Pancreatic Cancer, Colorectal Cancer, or Other Solid Tumors That Cannot Be Removed by Surgery
Safety and Immunologic Activity of Multiple Infusions of APN401
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Wake Forest University Health Sciences · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase I trial studies the side effects and best dose of APN401 in treating patients with pancreatic cancer, colorectal cancer, or other solid tumors that have spread to other places in the body or have come back. APN401 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVES: I. To determine the toxicities and establish the safety of multiple infusions of small interfering ribonucleic acid (siRNA)-transfected peripheral blood mononuclear cells APN401 (APN401). SECONDARY OBJECTIVES: I. To determine the immunologic effects of multiple infusions of APN401. II. To document clinical response and survival. OUTLINE: Patients receive siRNA-transfected peripheral blood mononuclear cells APN401 intravenously (IV) over 30 minutes on days 1, 29, and 57 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 5 years.
Conditions
- Metastatic Malignant Neoplasm in the Brain
- Metastatic Solid Neoplasm
- Recurrent Colorectal Carcinoma
- Recurrent Pancreatic Carcinoma
- Recurrent Solid Neoplasm
- Stage IV Colorectal Cancer
- Stage IV Pancreatic Cancer
- Stage IVA Colorectal Cancer
- Stage IVA Pancreatic Cancer
- Stage IVB Colorectal Cancer
- Stage IVB Pancreatic Cancer
- Unresectable Solid Neoplasm
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
| BIOLOGICAL | siRNA-transfected Peripheral Blood Mononuclear Cells (PBMC) APN401 | Given IV |
Timeline
- Start date
- 2017-04-28
- Primary completion
- 2019-07-31
- Completion
- 2020-12-08
- First posted
- 2017-03-22
- Last updated
- 2024-10-10
- Results posted
- 2024-10-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03087591. Inclusion in this directory is not an endorsement.