NCT05212025

Adavosertib and Gemcitabine in Advanced Pancreatic

Phase 2 Single Arm Trial Testing Adavosertib and Gemcitabine in Platinum-Resistant Advanced Pancreatic Adenocarcinoma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: James Cleary, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to test the safety and effectiveness of combining Adavosertib and Gemcitabine in patients with pancreatic cancer. The names of the study drugs involved in this study are: * Adavosertib * Gemcitabine

Detailed description

This is an open label, single arm phase 2 trial evaluating adavosertib combined with gemcitabine in platinum-resistant advanced pancreatic cancer. Laboratory studies suggest that adavosertib and gemcitabine can impair the growth of cancers by interfering with the way cancer cells repair their DNA. The U.S. Food and Drug Administration (FDA) has not approved adavosertib as a treatment for any disease. The U.S. Food and Drug Administration (FDA) has approved gemcitabine as a treatment option for pancreatic cancer. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. It is expected that about 32 people will take part in this research study. The Lustgarten Foundation for Pancreatic Research and Stand Up to Cancer are supporting this research study by providing funding to conduct the study. AstraZeneca, a pharmaceutical company, is supplying the study drug, Adavosertib.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Adavosertib	Taken Orally
DRUG	Gemcitabine	Intravenous Infusion

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-06-01
• Completion: 2023-12-31
• First posted: 2022-01-27
• Last updated: 2022-06-14

Regulatory

• FDA-regulated drug study