Trials / Completed
CompletedNCT04861987
A Study of the Safety and PK of PCS6422 (Eniluracil) with Capecitabine in Patients with Advanced, Refractory GI Tract Tumors
A Phase 1b Dose-escalation Study of the Safety and Pharmacokinetics of Fixed-dose PCS6422 with Escalating Doses of Capecitabine Administered Orally to Patients with Advanced, Refractory Gastrointestinal Tract Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Processa Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is an open label, multicenter study in patients who have advanced, relapsed refractory GI cancer or are not relapsed/refractory but are intolerant to other therapies who, in the judgment of investigators, are candidates for fluoropyrimidine monotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PCS6422 and capecitabine | PCS6422 is an experimental drug that, when combined with capecitabine, may make the immune response more active against cancer. Capecitabine is a commonly used oral fluoropyrimidine. |
Timeline
- Start date
- 2021-06-18
- Primary completion
- 2024-06-12
- Completion
- 2024-09-09
- First posted
- 2021-04-27
- Last updated
- 2024-10-10
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04861987. Inclusion in this directory is not an endorsement.