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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 18\

⁃ 80 years old, male or female;

• Locally advanced unresectable or metastatic PDAC confirmed by histopathology or cytopathology;

• Patients who have not received prior systemic therapy for locally advanced or metastatic pancreatic cancer;

• Patients with at least one measurable tumor lesion per RECIST v1.1;

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

• Expected survival time ≥ 12 weeks;

• Patients who have adequate organ function;

• Female subjects who are not pregnant or not breastfeeding. A negative pregnancy test for females of childbearing potential within 7 days prior to first dosing. Male and female subjects of childbearing potential must agree to use highly effective method of contraception during the entire course of the study and within 180 days after the end of the study.

• Subjects participate voluntarily and sign informed consent.

Locations
Other Locations
China
Chinese People's Liberation Army (PLA) General Hospital
RECRUITING
Beijing
Contact Information
Primary
Jianming Xu, M.D
Jianmingxu2014@163.com
13910866712
Time Frame
Start Date: 2024-03-19
Estimated Completion Date: 2026-10
Participants
Target number of participants: 120
Treatments
Experimental: CEND-1+ nab-paclitaxel + gemcitabine
Participants will receive nab-paclitaxel 125mg/m2; CEND1 3.2mg/kg IV; and then Gemcitabine 1000mg/m2, on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
Placebo_comparator: Placebo+ nab-paclitaxel + gemcitabine
Participants will receive nab-paclitaxel 125mg/m2; placebo IV; and then Gemcitabine 1000mg/m2, on Day 1, 8 and 15 of each cycle. Each cycle will be 28 days.
Related Therapeutic Areas
Sponsors
Leads: Qilu Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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