Trials / Recruiting
RecruitingNCT06261359
A Study of CEND-1 With Chemotherapy as First-Line Therapy in Patients With Pancreatic Ductal Adenocarcinoma
A Phase II, Randomized, Double-blind, Multi-center, Placebo-Controlled Study of the Efficacy and Safety of CEND-1 in Combination With Chemotherapy as First-Line Therapy in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Qilu Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of CEND-1 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo as first-line treatment in patients with Locally Advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CEND-1 | CEND-1 will be provided as concentrate for solution to be administered via IV injection. |
| DRUG | Gemcitabine | Gemcitabine will be provided as solution to be administered via IV infusion. |
| DRUG | Nab paclitaxel | Nab-paclitaxel will be provided as solution to be administered via IV infusion. |
Timeline
- Start date
- 2024-03-19
- Primary completion
- 2025-04-01
- Completion
- 2026-10-01
- First posted
- 2024-02-15
- Last updated
- 2024-09-04
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06261359. Inclusion in this directory is not an endorsement.