Trials / Terminated
TerminatedNCT04193904
A Study of Live Biotherapeutic Product MRx0518 With Hypofractionated Radiation Therapy in Resectable Pancreatic Cancer
A Safety and Preliminary Efficacy Study of the Oral Live Biotherapeutic MRx0518 With Hypofractionated Preoperative Radiation for Resectable Pancreatic Cancer
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- 4D pharma plc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a single center, open-label, phase I study to evaluate the safety and preliminary efficacy of MRx0518 with preoperative hypofractionated radiation in 15 patients with resectable pancreatic cancer. Subjects will take MRx0518 daily for one week prior to the start of radiation therapy, throughout radiation and until surgical resection of the tumour.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MRx0518 | MRx0518 is a live biotherapeutic product consisting of a lyophilised formulation of a proprietary strain of bacterium. The study dosing regimen is one capsule two times per day for the duration of the treatment period. |
| RADIATION | Hypofractionated Preoperative Radiation | Radiation will be delivered as 30Gy/10 fractions over two weeks. |
Timeline
- Start date
- 2019-12-20
- Primary completion
- 2023-05-08
- Completion
- 2023-05-08
- First posted
- 2019-12-10
- Last updated
- 2023-06-02
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04193904. Inclusion in this directory is not an endorsement.