Trials / Terminated
TerminatedNCT05546411
A Trial of NIS793 With FOLFIRINOX in Pancreatic Cancer
A Phase 2 Study of Neoadjuvant NIS793 in Combination With mFOLFIRINOX in Resectable and Borderline Resectable Pancreatic Adenocarcinoma (PDAC)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Kimberly Perez, MD · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is being done to evaluate the safety and efficacy of adding NIS793 to standard of care FOLFIRINOX treatment for pancreatic cancer. The names of the study interventions involved in this study are: * NIS793 * FOLFIRINOX (Folinic acid/Leucovorin, 5-Fluorouracil, Irinotecan, and Oxaliplatin) Other interventions may include: * Chemoradiation Therapy * Surgery
Detailed description
This is a randomized phase 2 study evaluating the efficacy of NIS793, a TGF-beta inhibitor, when added to a standard chemotherapy program of modified FOLFIRINOX for people with previously-untreated, resectable or borderline resectable pancreatic adenocarcinoma. The U.S. Food and Drug Administration (FDA) has not approved NIS793 as a treatment for any disease. NIS793 works by blocking a molecule called TGF-beta. TGFbeta has been shown to promote the growth of pancreatic cancer and this study is examining if the addition of a TGF-beta blocking drug will allow the chemotherapy to work better against the cancer. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will be randomized into two groups of: * Arm A will receive standard chemotherapy, mFOLFIRINOX, in combination with NIS793. * Arm B will receive standard chemotherapy, mFOLFIRINOX. Based on study team determination, some participants may be offered chemoradiation following completion of chemotherapy and/or surgery following either completion of chemotherapy or chemoradiation. Study treatment is expected to last up to 16 weeks unless disease symptom worsens . It is expected that about 45 people will take part in this research study.
Conditions
- Pancreatic Cancer
- Resectable Pancreatic Cancer
- Borderline Resectable Pancreatic Adenocarcinoma
- Pancreatic Adenocarcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | mFOLFIRINOX | Combination of the drugs 5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Leucovorin given by intravenous infusion |
| DRUG | 5-Fluorouracil (5-FU) | Part of the FOLFIRINOX drug combination, given by intravenous infusion |
| DRUG | Oxaliplatin | Part of the FOLFIRINOX drug combination, given by intravenous infusion |
| DRUG | Irinotecan | Part of the FOLFIRINOX drug combination, given by intravenous infusion |
| DRUG | Leucovorin | Part of the FOLFIRINOX drug combination, given by intravenous infusion |
| DRUG | NIS793 | Given by intravenous infusion |
| RADIATION | Chemoradiation | Combination of Chemo (Capecitabine) and Radiation Therapy |
| PROCEDURE | Surgery | Surgical removal of tumor |
Timeline
- Start date
- 2023-01-06
- Primary completion
- 2023-08-16
- Completion
- 2023-10-13
- First posted
- 2022-09-19
- Last updated
- 2024-12-17
- Results posted
- 2024-07-16
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05546411. Inclusion in this directory is not an endorsement.